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TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) (TTEDD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00451321
Recruitment Status : Terminated
First Posted : March 23, 2007
Results First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Intervention Drug: Otelixizumab
Enrollment 88
Recruitment Details The study was conducted at 17 centers from United States and Canada during the period 31 July 2006 to 1 December 2011.
Pre-assignment Details Participants from all 7 cohorts who had received a total dose <3.0 milligrams (mg) were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort. Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Period Title: Overall Study
Started 8 15 18 19 7 9 6 6
Completed 1 10 0 7 0 0 0 0
Not Completed 7 5 18 12 7 9 6 6
Reason Not Completed
Lost to Follow-up             3             3             1             3             0             1             0             0
Withdrawal by Subject             3             1             0             4             0             0             0             0
Study closed/terminated             1             1             17             5             7             7             5             3
Sponsor decision to amend protocol             0             0             0             0             0             1             1             3
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg Total
Hide Arm/Group Description Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort. Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days. Total of all reporting groups
Overall Number of Baseline Participants 8 15 18 19 7 9 6 6 88
Hide Baseline Analysis Population Description
Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants 88 participants
29.8  (11.36) 42.3  (13.25) 18.9  (5.17) 34.6  (9.89) 36.1  (9.70) 28.9  (10.74) 37.2  (14.37) 28.8  (6.79) 31.6  (12.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants 88 participants
Female
6
  75.0%
5
  33.3%
5
  27.8%
9
  47.4%
4
  57.1%
5
  55.6%
3
  50.0%
2
  33.3%
39
  44.3%
Male
2
  25.0%
10
  66.7%
13
  72.2%
10
  52.6%
3
  42.9%
4
  44.4%
3
  50.0%
4
  66.7%
49
  55.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants 88 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
White
8
 100.0%
15
 100.0%
16
  88.9%
19
 100.0%
7
 100.0%
9
 100.0%
6
 100.0%
6
 100.0%
86
  97.7%
More than one race
0
   0.0%
0
   0.0%
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   1.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
The ‘All Subjects population’ was defined as all participants who received at least one dose of study medication and was used in all study population and safety analyses. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 18 19 7 9 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Any AEs
8
 100.0%
15
 100.0%
18
 100.0%
18
  94.7%
7
 100.0%
9
 100.0%
6
 100.0%
6
 100.0%
Any SAEs
1
  12.5%
2
  13.3%
1
   5.6%
0
   0.0%
0
   0.0%
1
  11.1%
1
  16.7%
2
  33.3%
2.Primary Outcome
Title Number of Participants With Cytokine Release AE
Hide Description AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Cytokine release AEs were defined as occurring during dosing or within a limited time window after the last dose.
Time Frame Up to Month 24
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 18 19 7 9 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
11
  73.3%
18
 100.0%
17
  89.5%
7
 100.0%
9
 100.0%
6
 100.0%
6
 100.0%
3.Primary Outcome
Title Number of Participants With Abnormal Hematology Values of Potential Clinical Concern (PCC)
Hide Description Hematology parameters: hemoglobin, white blood cell (WBC) count, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelet count, mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.
Time Frame Up to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 18 19 7 9 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Lymphocytes, low
4
  50.0%
12
  80.0%
18
 100.0%
17
  89.5%
7
 100.0%
9
 100.0%
5
  83.3%
5
  83.3%
WBC, low
3
  37.5%
4
  26.7%
12
  66.7%
5
  26.3%
3
  42.9%
5
  55.6%
3
  50.0%
4
  66.7%
Hemoglobin, high
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Neutrophils, low
1
  12.5%
2
  13.3%
11
  61.1%
1
   5.3%
3
  42.9%
2
  22.2%
3
  50.0%
2
  33.3%
Platelets, low
0
   0.0%
2
  13.3%
4
  22.2%
2
  10.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Platelets, high
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
1
  11.1%
1
  16.7%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Abnormal Clinical Chemistry Values of PCC
Hide Description Clinical chemistry parameters: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transferase, lactate dehydrogenase, lipids, blood urea nitrogen, creatinine, uric acid, sodium, potassium, chloride, carbon dioxide, creatinine phosphokinase, albumin, calcium, magnesium, glucose, phosphate, bicarbonate and total protein were assessed for abnormal PCC values. Data for abnormal parameters (high and low) is presented. Only those parameters for which at least one value of PCC was reported are summarized.
Time Frame Up to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 18 19 7 9 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
ALT, high
1
  12.5%
1
   6.7%
2
  11.1%
1
   5.3%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
AST, high
1
  12.5%
0
   0.0%
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fasting glucose, high
1
  12.5%
0
   0.0%
1
   5.6%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
Fasting glucose, low
0
   0.0%
2
  13.3%
0
   0.0%
2
  10.5%
1
  14.3%
2
  22.2%
1
  16.7%
0
   0.0%
Potassium, high
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bicarbonate, high
0
   0.0%
0
   0.0%
2
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Bicarbonate, low
0
   0.0%
1
   6.7%
1
   5.6%
0
   0.0%
1
  14.3%
1
  11.1%
0
   0.0%
0
   0.0%
Calcium, low
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
1
  16.7%
1
  16.7%
Magnesium, high
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Alkaline phosphatase, high
0
   0.0%
0
   0.0%
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Total billirubin, high
0
   0.0%
0
   0.0%
1
   5.6%
2
  10.5%
0
   0.0%
0
   0.0%
1
  16.7%
1
  16.7%
5.Primary Outcome
Title Number of Participants With Abnormal Urinalysis Dipstick Results
Hide Description Urinalysis parameters: Occult blood, Glucose urine, Ketones, Leukocyte esterase, Nitrite, pH, Protein urine were assessed. Abnormal values for occult blood and ketones were presented as 1+, 2+ and 3+ (the plus sign increases with a higher level of parameters: 1+=slightly positive, 2+=positive, 3+=high positive). Abnormal glucose urine values were presented as 50, 100, 250 and 1000 mg/dL. Abnormal nitrite values were presented as ‘positive’, and abnormal urine protein values were presented as 30 and 100 mg/dL.
Time Frame Up to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 18 19 7 9 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Occult blood, Day 8, 3+
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Occult blood, Month 12, 1+
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
Occult blood, Month 12, 2+
0
   0.0%
0
   0.0%
0
   0.0%
3
  15.8%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
Occult blood, Month 12, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Occult blood, Month 24, 1+
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Occult blood, Month 24, 3+
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Occult blood, Month 36, 2+
1
  12.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Occult blood, Month 36, 3+
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine glucose, Day 8, 500
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine glucose, Month 12, 100
0
   0.0%
0
   0.0%
0
   0.0%
2
  10.5%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine glucose, Month 12, 1000
2
  25.0%
5
  33.3%
0
   0.0%
5
  26.3%
1
  14.3%
2
  22.2%
0
   0.0%
2
  33.3%
Urine glucose, Month 12, 250
0
   0.0%
1
   6.7%
0
   0.0%
2
  10.5%
1
  14.3%
1
  11.1%
1
  16.7%
1
  16.7%
Urine glucose, Month 12, 50
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine glucose, Month 24, 100
0
   0.0%
1
   6.7%
0
   0.0%
1
   5.3%
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
Urine glucose, Month 24, 1000
1
  12.5%
3
  20.0%
0
   0.0%
3
  15.8%
3
  42.9%
2
  22.2%
3
  50.0%
2
  33.3%
Urine glucose, Month 24, 250
0
   0.0%
3
  20.0%
0
   0.0%
1
   5.3%
2
  28.6%
1
  11.1%
1
  16.7%
1
  16.7%
Urine glucose, Month 24, 500
0
   0.0%
1
   6.7%
0
   0.0%
2
  10.5%
0
   0.0%
1
  11.1%
0
   0.0%
1
  16.7%
Urine glucose, Month 36, 1000
0
   0.0%
2
  13.3%
0
   0.0%
5
  26.3%
0
   0.0%
2
  22.2%
1
  16.7%
0
   0.0%
Urine glucose, Month 36, 250
0
   0.0%
2
  13.3%
0
   0.0%
2
  10.5%
0
   0.0%
1
  11.1%
1
  16.7%
0
   0.0%
Urine glucose, Month 36, 500
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
Urine glucose, Month 48, 100
0
   0.0%
1
   6.7%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine glucose, Month 48, 1000
1
  12.5%
3
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine glucose, Month 48, 250
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine ketones, Month 12, 1+
1
  12.5%
4
  26.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Urine ketones, Month 12, 2+
1
  12.5%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
1
  16.7%
0
   0.0%
Urine ketones, Month 12, 3+
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine ketones, Month 24, 1+
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
1
  11.1%
1
  16.7%
1
  16.7%
Urine ketones, Month 24, 2+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Urine ketones, Month 24, 3+
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Urine ketones, Month 36, 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Urine ketones, Month 36, 2+
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
Urine ketones, Month 48, 1+
0
   0.0%
1
   6.7%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Leukocyte esterase, Month 12, 1+
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
Leukocyte esterase, Month 12, 2+
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Leukocyte esterase, Month 24, 1+
0
   0.0%
1
   6.7%
0
   0.0%
1
   5.3%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Leukocyte esterase, Month 24, 3+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
Leukocyte esterase, Month 36, 1+
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Nitrite, Month 12, positive
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nitrite, Month 24, positive
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Nitrite, Month 36, positive
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Protein urine, Month 12, 30
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Protein urine, Month 24, 100
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Protein urine, Month 48, 30
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Mean Overall Maximum Cytokines Level
Hide Description Levels of cytokines: interferon (IFN)-gamma, interleukin (IL)-10, IL-6 and tumor necrosis factor (TNF)–alpha were assessed. One sample was collected at Baseline, on dose Day 1 at 1, 2, 3, and 8 hours post-end of infusion (EOI) and on all other dosing days at pre-dose, and 1, 2, 3, and 8 hour post-EOI. After the completion of dosing, on Day 21 and Week 8, only the IL-10 level was assessed in the cytokine blood sample.
Time Frame Up to Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects Population. Only those participants available for analysis for the particular parameter are presented. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 18 19 7 9 6 6
Mean (Standard Deviation)
Unit of Measure: Picograms per milliliter (pg/mL)
IFN-Gamma Number Analyzed 1 participants 1 participants 4 participants 3 participants 1 participants 1 participants 2 participants 3 participants
55.180 [1]   (NA) 20.170 [1]   (NA) 25.878  (19.0272) 20.410  (15.6070) 40.860 [1]   (NA) 9.730 [1]   (NA) 23.210  (12.7279) 30.463  (23.4652)
IL-10 Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
146.084  (337.2007) 44.609  (48.1712) 58.743  (59.6380) 75.879  (66.3559) 80.267  (51.6266) 82.786  (68.4322) 193.065  (225.7715) 82.547  (55.4185)
IL-6 Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
101.161  (193.9999) 71.748  (78.0909) 75.954  (63.2599) 83.739  (65.1953) 111.567  (115.1136) 121.862  (99.0309) 358.890  (544.0678) 186.593  (200.7019)
TNF-Alpha Number Analyzed 8 participants 15 participants 17 participants 19 participants 7 participants 9 participants 6 participants 6 participants
18.079  (10.2902) 23.071  (29.9426) 34.814  (40.1511) 27.225  (37.5837) 51.503  (36.9749) 69.678  (145.2403) 50.877  (74.6931) 44.232  (51.2616)
[1]
Only one participant was analyzed, hence no data.
7.Primary Outcome
Title Number of Participants With Positive Epstein Barr Virus (EBV) Viral Load
Hide Description EBV load was measured using quantitative polymerase chain reaction (PCR) method. If a participant had an EBV viral load of >100,000 copies/10^6 peripheral blood mononuclear cells (c/10^6 PBMC) lymphocytes at any time post-dose, the test was repeated immediately. Data for participants with abnormal viral load is presented.
Time Frame Up to Month 18
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 18 19 7 9 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Screening, 1-10000 Number Analyzed 8 participants 10 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
2
  25.0%
1
  10.0%
0
   0.0%
1
   5.3%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
Day 14, 1-10000 Number Analyzed 7 participants 14 participants 18 participants 19 participants 7 participants 8 participants 6 participants 5 participants
1
  14.3%
4
  28.6%
5
  27.8%
3
  15.8%
1
  14.3%
2
  25.0%
0
   0.0%
2
  40.0%
Day 21, 1-10000 Number Analyzed 7 participants 15 participants 17 participants 18 participants 7 participants 9 participants 6 participants 6 participants
0
   0.0%
6
  40.0%
4
  23.5%
3
  16.7%
3
  42.9%
3
  33.3%
1
  16.7%
2
  33.3%
Day 21, >10000 Number Analyzed 7 participants 15 participants 17 participants 18 participants 7 participants 9 participants 6 participants 6 participants
1
  14.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 28, 1-10000 Number Analyzed 7 participants 15 participants 18 participants 18 participants 6 participants 8 participants 6 participants 6 participants
2
  28.6%
3
  20.0%
6
  33.3%
1
   5.6%
3
  50.0%
0
   0.0%
2
  33.3%
2
  33.3%
Week 6, 1-10000 Number Analyzed 7 participants 14 participants 18 participants 17 participants 7 participants 9 participants 6 participants 5 participants
1
  14.3%
3
  21.4%
1
   5.6%
2
  11.8%
0
   0.0%
2
  22.2%
0
   0.0%
1
  20.0%
Week 12, 1-10000 Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 8 participants 6 participants 6 participants
0
   0.0%
0
   0.0%
2
  11.1%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Month 6, 1-10000 Number Analyzed 4 participants 14 participants 17 participants 19 participants 7 participants 8 participants 6 participants 6 participants
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
0
   0.0%
2
  33.3%
Month 18, 1-10000 Number Analyzed 3 participants 10 participants 5 participants 15 participants 6 participants 8 participants 6 participants 5 participants
1
  33.3%
0
   0.0%
0
   0.0%
2
  13.3%
1
  16.7%
1
  12.5%
1
  16.7%
0
   0.0%
Month 12, 1-10000 Number Analyzed 4 participants 10 participants 13 participants 19 participants 6 participants 8 participants 6 participants 6 participants
1
  25.0%
1
  10.0%
0
   0.0%
2
  10.5%
1
  16.7%
4
  50.0%
0
   0.0%
0
   0.0%
8.Secondary Outcome
Title Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUClast) of Otelixizumab
Hide Description Pharmacokinetic (PK) samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 micrograms per milliliter (µg/mL). The ‘PK summary Population' was defined as participants in the ‘All Subjects’ Population for whom a pharmacokinetic sample was obtained and analyzed, and who received the full scheduled dose, as specified in the protocol. Only those participants available at the specified time points were analyzed.
Time Frame At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-start of infusion (SOI). On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.
Hide Outcome Measure Data
Hide Analysis Population Description
PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 14 0 15 7 9 6 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*micrograms per milliliter
Day 1 Number Analyzed 0 participants 0 participants 0 participants 3 participants 1 participants 0 participants 0 participants 0 participants
0.03961
(139.9399%)
0.89984 [1] 
(NA%)
Day 4 Number Analyzed 0 participants 2 participants 0 participants 12 participants 3 participants 1 participants 4 participants 2 participants
0.01791
(48.7376%)
0.02752
(78.0203%)
0.06047
(809.8761%)
0.02595 [1] 
(NA%)
0.01701
(47.9050%)
0.01370
(3.6149%)
Day 7 Number Analyzed 0 participants 9 participants 0 participants 13 participants 4 participants 3 participants 6 participants 2 participants
0.01789
(66.5077%)
0.08946
(161.9423%)
0.15744
(1108.625%)
0.02332
(27.3059%)
0.19563
(665.7708%)
0.20039
(80.3599%)
Day 8 Number Analyzed 0 participants 10 participants 0 participants 13 participants 4 participants 6 participants 6 participants 3 participants
0.01848
(73.4326%)
0.14250
(93.2214%)
0.08367
(280.2741%)
0.06685
(188.0044%)
0.62938
(256.4433%)
1.34488
(567.3411%)
[1]
Only one participant was analyzed.
9.Secondary Outcome
Title Maximum Plasma Drug Concentration (Cmax) of Otelixizumab
Hide Description PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.
Time Frame At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.
Hide Outcome Measure Data
Hide Analysis Population Description
PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 14 0 15 7 9 6 3
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg/mL
Day 1 Number Analyzed 0 participants 0 participants 0 participants 3 participants 1 participants 0 participants 0 participants 0 participants
0.04399
(124.5265%)
0.06370 [1] 
(NA%)
Day 4 Number Analyzed 0 participants 2 participants 0 participants 12 participants 3 participants 1 participants 4 participants 2 participants
0.03050
(42.9529%)
0.03862
(41.1649%)
0.03041
(30.4698%)
0.03460 [1] 
(NA%)
0.03160
(39.9688%)
0.02739
(3.6149%)
Day 7 Number Analyzed 0 participants 9 participants 0 participants 13 participants 4 participants 3 participants 6 participants 2 participants
0.02660
(37.1463%)
0.06715
(41.7413%)
0.05054
(41.4392%)
0.03075
(26.2309%)
0.12211
(118.6807%)
0.12601
(68.8972%)
Day 8 Number Analyzed 0 participants 10 participants 0 participants 13 participants 4 participants 6 participants 6 participants 3 participants
0.02988
(41.3271%)
0.06455
(45.7850%)
0.05519
(77.5056%)
0.03773
(41.5855%)
0.15106
(122.2439%)
0.23138
(254.9093%)
[1]
Only one participant was analyzed.
10.Secondary Outcome
Title Time of Last Quantifiable Drug Concentration (Tlast) and Time of Occurrence of Maximum Plasma Drug Concentration (Tmax) of Otelixizumab
Hide Description PK samples were obtained at Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour SOI. On Dose Day 5, samples were collected at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI. The lower limit of quantification was 0.019 µg/mL. Only those participants available at the specified time points were analyzed.
Time Frame At Baseline, and on all dose days except the final dose day, at pre-dose, EOI, and 4 hour post-SOI. On Dose Day 5, at pre-dose, EOI, and 3.5, 4, 5, and 8-10 hour post-SOI.
Hide Outcome Measure Data
Hide Analysis Population Description
PK summary Population. A limited comparison of the PK of free serum otelixizumab in adolescents and adults was attempted using the cumulative 3.1 mg dose regimen. However, there were insufficient quantifiable concentrations obtained in either group to allow meaningful conclusions to be drawn. Data for only quantifiable concentration is presented.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 14 0 15 7 9 6 3
Median (Full Range)
Unit of Measure: hour
tlast, Day 1 Number Analyzed 0 participants 0 participants 0 participants 3 participants 1 participants 0 participants 0 participants 0 participants
2.150
(2.08 to 4.05)
22.250
(22.25 to 22.25)
tlast, Day 4 Number Analyzed 0 participants 2 participants 0 participants 12 participants 3 participants 1 participants 4 participants 2 participants
2.175
(2.13 to 2.22)
2.133
(2.03 to 4.58)
2.250
(2.25 to 23.58)
2.500
(2.50 to 2.50)
2.075
(2.00 to 2.17)
2.000
(2.00 to 2.00)
tlast, Day 7 Number Analyzed 0 participants 9 participants 0 participants 13 participants 4 participants 3 participants 6 participants 2 participants
2.217
(2.00 to 4.00)
4.000
(2.00 to 23.67)
12.375
(2.25 to 23.47)
2.517
(2.50 to 2.53)
4.000
(2.00 to 20.70)
4.000
(4.00 to 4.00)
tlast, Day 8 Number Analyzed 0 participants 10 participants 0 participants 13 participants 4 participants 6 participants 6 participants 3 participants
2.075
(2.00 to 4.00)
5.033
(2.00 to 10.00)
3.250
(1.75 to 8.32)
3.500
(2.00 to 8.53)
10.000
(4.03 to 10.17)
12.000
(6.00 to 12.03)
tmax, Day 1 Number Analyzed 0 participants 0 participants 0 participants 3 participants 1 participants 0 participants 0 participants 0 participants
2.083
(2.00 to 2.15)
2.42
(2.42 to 2.42)
tmax, Day 4 Number Analyzed 0 participants 2 participants 0 participants 12 participants 3 participants 1 participants 4 participants 2 participants
2.175
(2.13 to 2.22)
2.108
(1.92 to 2.53)
2.250
(2.25 to 2.30)
2.500
(2.50 to 2.50)
2.075
(2.00 to 2.17)
2.000
(2.00 to 2.00)
tmax, Day 7 Number Analyzed 0 participants 9 participants 0 participants 13 participants 4 participants 3 participants 6 participants 2 participants
2.100
(2.00 to 2.33)
2.083
(2.00 to 2.20)
2.308
(2.25 to 22.47)
2.517
(2.50 to 2.53)
2.033
(2.00 to 2.33)
3.042
(2.08 to 4.00)
tmax, Day 8 Number Analyzed 0 participants 10 participants 0 participants 13 participants 4 participants 6 participants 6 participants 3 participants
2.075
(2.00 to 2.27)
2.167
(2.00 to 2.75)
2.000
(1.75 to 3.28)
2.000
(2.00 to 2.50)
3.500
(2.00 to 4.12)
4.000
(4.00 to 4.03)
11.Secondary Outcome
Title Mean Lymphocytes Subsets (CD19+ B Cells, CD4+CD25hiFoxP3+ T Cells, CD8+CD25+FoxP3+ T Cells) Count
Hide Description One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD19+ B cells, CD4+CD25hiFoxP3+ T cells, CD8+CD25+FoxP3+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented. The ‘Pharmacodynamic (PD) summary population' was defined as participants in the ‘All Subjects’ Population for whom a PD sample was obtained and analyzed and who received the full scheduled dose, as specified in the protocol.
Time Frame Day 8 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 14 0 18 7 9 6 4
Mean (Standard Deviation)
Unit of Measure: Cells per microliter
CD19+ B Cells, Baseline Number Analyzed 0 participants 12 participants 0 participants 17 participants 6 participants 8 participants 6 participants 4 participants
0.187  (0.1360) 0.247  (0.1029) 0.288  (0.1173) 0.393  (0.2125) 0.200  (0.0873) 0.220  (0.0922)
CD19+ B Cells, Day 8, pre-dose Number Analyzed 0 participants 14 participants 0 participants 18 participants 7 participants 9 participants 6 participants 4 participants
0.182  (0.1697) 0.180  (0.0627) 0.146  (0.0305) 0.203  (0.1019) 0.099  (0.0468) 0.151  (0.0906)
CD19+ B Cells, Day 8, 15 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.170  (0.0446)
CD19+ B Cells, Day 8, 30 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.204  (0.1094)
CD19+ B Cells, Day 8, 2 hours Number Analyzed 0 participants 14 participants 0 participants 17 participants 0 participants 0 participants 6 participants 4 participants
0.177  (0.1528) 0.162  (0.0570) 0.087  (0.0604) 0.099  (0.0869)
CD19+ B Cells, Day 8, 2.25 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.156  (0.0602)
CD19+ B Cells, Day 8, 2.5 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 8 participants 0 participants 0 participants
0.161  (0.0737)
CD19+ B Cells, Day 8, 4 hours Number Analyzed 0 participants 13 participants 0 participants 17 participants 0 participants 0 participants 6 participants 4 participants
0.186  (0.1314) 0.167  (0.0699) 0.084  (0.0523) 0.083  (0.0465)
CD19+ B Cells, Day 28 Number Analyzed 0 participants 14 participants 0 participants 16 participants 6 participants 8 participants 6 participants 4 participants
0.198  (0.1978) 0.210  (0.0634) 0.156  (0.0553) 0.279  (0.1558) 0.167  (0.0470) 0.153  (0.0783)
CD4+CD25hiFoxP3+T cells, Baseline Number Analyzed 0 participants 12 participants 0 participants 18 participants 6 participants 8 participants 6 participants 4 participants
0.0138  (0.01010) 0.0099  (0.01142) 0.0180  (0.00865) 0.0165  (0.01262) 0.0089  (0.00948) 0.0379  (0.02839)
CD4+CD25hiFoxP3+T cells, Day 8, pre-dose Number Analyzed 0 participants 14 participants 0 participants 18 participants 7 participants 9 participants 6 participants 4 participants
0.0062  (0.00497) 0.0039  (0.00425) 0.0056  (0.00488) 0.0105  (0.00693) 0.0028  (0.00180) 0.0237  (0.01067)
CD4+CD25hiFoxP3+T cells, Day 8, 15 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.0039  (0.00549)
CD4+CD25hiFoxP3+T cells, Day 8, 30 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.0033  (0.00283)
CD4+CD25hiFoxP3+T cells, Day 8, 2 hours Number Analyzed 0 participants 14 participants 0 participants 17 participants 0 participants 0 participants 6 participants 4 participants
0.0035  (0.00336) 0.0015  (0.00265) 0.0013  (0.00178) 0.0055  (0.00466)
CD4+CD25hiFoxP3+T cells, Day 8, 2.25 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.0034  (0.00409)
CD4+CD25hiFoxP3+T cells, Day 8, 2.5 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.0027  (0.00293)
CD4+CD25hiFoxP3+T cells, Day 8, 4 hours Number Analyzed 0 participants 13 participants 0 participants 18 participants 0 participants 0 participants 6 participants 4 participants
0.0038  (0.00380) 0.0017  (0.00285) 0.0012  (0.00125) 0.0047  (0.00379)
CD4+CD25hiFoxP3+T cells, Day 28 Number Analyzed 0 participants 14 participants 0 participants 15 participants 6 participants 8 participants 6 participants 4 participants
0.0132  (0.01176) 0.0096  (0.01231) 0.0163  (0.00740) 0.0200  (0.01421) 0.0163  (0.00635) 0.0253  (0.01205)
CD8+CD25+FoxP3+T cells, Baseline Number Analyzed 0 participants 12 participants 0 participants 18 participants 6 participants 8 participants 6 participants 4 participants
0.0001  (0.00264) 0.0032  (0.00699) 0.0230  (0.03795) -0.0086  (0.02386) 0.0020  (0.00153) 0.0027  (0.00825)
CD8+CD25+FoxP3+T cells, Day 8, pre-dose Number Analyzed 0 participants 14 participants 0 participants 18 participants 7 participants 9 participants 6 participants 4 participants
0.0006  (0.00211) 0.0011  (0.00302) 0.0048  (0.01791) 0.0054  (0.00563) 0.0000  (0.00213) -0.0006  (0.00360)
CD8+CD25+FoxP3+T cells, Day 8, 15 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.0096  (0.01322)
CD8+CD25+FoxP3+T cells, Day 8, 30 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.0138  (0.03663)
CD8+CD25+FoxP3+T cells, Day 8, 2 hours Number Analyzed 0 participants 14 participants 0 participants 17 participants 0 participants 0 participants 6 participants 4 participants
0.0020  (0.00241) 0.0005  (0.00291) -0.0001  (0.00187) 0.0036  (0.00420)
CD8+CD25+FoxP3+T cells, Day 8, 2.25 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
-0.0057  (0.01376)
CD8+CD25+FoxP3+T cells, Day 8, 2.5 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.0045  (0.01405)
CD8+CD25+FoxP3+T cells, Day 8, 4 hours Number Analyzed 0 participants 13 participants 0 participants 18 participants 0 participants 0 participants 6 participants 4 participants
0.0052  (0.01082) -0.0006  (0.00443) 0.0007  (0.00085) 0.0008  (0.00459)
CD8+CD25+FoxP3+T cells, Day 28 Number Analyzed 0 participants 14 participants 0 participants 16 participants 6 participants 8 participants 6 participants 4 participants
0.0036  (0.00443) -0.0045  (0.01304) 0.0037  (0.01012) 0.0005  (0.01527) 0.0004  (0.00382) 0.0105  (0.01099)
12.Secondary Outcome
Title Mean Lymphocytes Subsets (CD4+ T Cells, CD8+ T Cells) Count
Hide Description One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. To obtain absolute counts for each lymphocyte subset (CD4+ T cells, CD8+ T cells) the proportion of total lymphocytes constituting that subset was multiplied by the total count for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Time Frame Day 8 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 14 17 18 7 9 6 4
Mean (Standard Deviation)
Unit of Measure: Cells per microliter
CD4+ T cells, Baseline Number Analyzed 0 participants 12 participants 16 participants 18 participants 6 participants 8 participants 6 participants 4 participants
0.943  (0.2982) 0.841  (0.2111) 0.959  (0.2726) 0.802  (0.1535) 0.929  (0.1879) 0.961  (0.5173) 1.007  (0.2653)
CD4+ T cells, Day 8 Number Analyzed 0 participants 0 participants 17 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0.636  (0.1741)
CD4+ T cells, Day 8, pre-dose Number Analyzed 0 participants 14 participants 0 participants 18 participants 7 participants 9 participants 6 participants 4 participants
0.463  (0.1928) 0.416  (0.1511) 0.327  (0.1175) 0.329  (0.1348) 0.188  (0.0867) 0.386  (0.1154)
CD4+ T cells, Day 8, 15 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.233  (0.1504)
CD4+ T cells, Day 8, 30 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.113  (0.0779)
CD4+ T cells, Day 8, 2 hours Number Analyzed 0 participants 14 participants 0 participants 17 participants 0 participants 0 participants 6 participants 4 participants
0.296  (0.1341) 0.210  (0.1781) 0.108  (0.1202) 0.099  (0.0553)
CD4+ T cells, Day 8, 2.25 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.218  (0.1569)
CD4+ T cells, Day 8, 2.5 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.117  (0.0502)
CD4+ T cells, Day 8, 4 hours Number Analyzed 0 participants 13 participants 0 participants 18 participants 0 participants 0 participants 6 participants 4 participants
0.397  (0.1779) 0.267  (0.1799) 0.126  (0.0962) 0.112  (0.0469)
CD4+ T cells, Day 28 Number Analyzed 0 participants 14 participants 15 participants 16 participants 6 participants 8 participants 6 participants 4 participants
0.835  (0.2971) 0.812  (0.2211) 0.978  (0.3193) 0.743  (0.1846) 0.797  (0.1824) 0.927  (0.2153) 0.689  (0.2199)
CD8+ T cells, Baseline Number Analyzed 0 participants 12 participants 16 participants 18 participants 6 participants 8 participants 6 participants 4 participants
0.586  (0.2370) 0.442  (0.1404) 0.425  (0.1213) 0.466  (0.1720) 0.519  (0.2813) 0.437  (0.1761) 0.638  (0.1711)
CD8+ T cells, Day 8 Number Analyzed 0 participants 0 participants 17 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0.324  (0.1370)
CD8+ T cells, Day 8, pre-dose Number Analyzed 0 participants 14 participants 0 participants 18 participants 7 participants 9 participants 6 participants 4 participants
0.242  (0.1133) 0.192  (0.0873) 0.149  (0.0297) 0.161  (0.0815) 0.143  (0.1248) 0.298  (0.1108)
CD8+ T cells, Day 8, 15 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.124  (0.0577)
CD8+ T cells, Day 8, 30 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.093  (0.0558)
CD2+ T cells, Day 8, 2 hours Number Analyzed 0 participants 14 participants 0 participants 17 participants 0 participants 0 participants 6 participants 4 participants
0.183  (0.1143) 0.134  (0.0981) 0.072  (0.0776) 0.121  (0.0731)
CD8+ T cells, Day 8, 2.25 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
0.120  (0.0563)
CD8+ T cells, Day 8, 2.5 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
0.076  (0.0323)
CD8+ T cells, Day 8, 4 hours Number Analyzed 0 participants 13 participants 0 participants 18 participants 0 participants 0 participants 6 participants 4 participants
0.211  (0.1255) 0.150  (0.1013) 0.095  (0.0857) 0.138  (0.0313)
CD8+ T cells, Day 28 Number Analyzed 0 participants 14 participants 15 participants 16 participants 6 participants 8 participants 6 participants 4 participants
0.533  (0.1924) 0.460  (0.1578) 0.510  (0.2168) 0.378  (0.0906) 0.444  (0.1838) 0.779  (0.3551) 0.507  (0.1596)
13.Secondary Outcome
Title Mean CD4+/CD8+ Ratio
Hide Description One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. CD4+/CD8+ ratio was determined by dividing the absolute count of CD4+ T cells by the absolute count of CD8+ T cells for the same participant at the same time point. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Time Frame Day 8 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 14 17 18 7 9 6 4
Mean (Standard Deviation)
Unit of Measure: Ratio
Baseline Number Analyzed 0 participants 13 participants 16 participants 18 participants 6 participants 8 participants 6 participants 4 participants
1.95  (0.952) 2.00  (0.551) 2.35  (0.783) 1.81  (0.339) 2.14  (0.846) 2.38  (1.099) 1.64  (0.465)
Day 8 Number Analyzed 0 participants 0 participants 17 participants 0 participants 0 participants 0 participants 0 participants 0 participants
2.12  (0.531)
Day 8, pre-dose Number Analyzed 0 participants 14 participants 0 participants 18 participants 7 participants 9 participants 6 participants 4 participants
2.15  (0.965) 2.36  (0.958) 2.15  (0.467) 2.12  (0.564) 1.80  (0.932) 1.34  (0.276)
Day 8, 15 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
1.72  (0.684)
Day 8, 30 minutes Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
1.17  (0.547)
Day 8, 2 hours Number Analyzed 0 participants 14 participants 0 participants 18 participants 0 participants 0 participants 6 participants 4 participants
1.82  (0.740) 1.51  (0.728) 1.62  (1.163) 0.85  (0.255)
Day 8, 2.25 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 7 participants 0 participants 0 participants 0 participants
1.72  (0.731)
Day 8, 2.5 hours Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 9 participants 0 participants 0 participants
1.56  (0.441)
Day 8, 4 hours Number Analyzed 0 participants 14 participants 0 participants 18 participants 0 participants 0 participants 6 participants 4 participants
2.11  (0.906) 1.86  (0.873) 1.72  (1.079) 0.80  (0.239)
Day 8, 10 hours Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants
1.36 [1]   (NA)
Day 28 Number Analyzed 0 participants 14 participants 16 participants 16 participants 6 participants 8 participants 6 participants 4 participants
1.69  (0.684) 1.87  (0.339) 2.08  (0.838) 2.00  (0.357) 2.02  (0.829) 1.61  (1.263) 1.38  (0.319)
[1]
Only one participant was analyzed, hence no data.
14.Secondary Outcome
Title Percent Lymphocytes Subsets (CD25+CD8+Tregs) Count
Hide Description One sample was collected at the screening visit and at Baseline. On dose Day 1, samples were collected at EOI and 4 hour post-SOI. On all other dosing days, samples were collected at pre-dose, EOI and 4 hour post-SOI. The data was collected on Baseline, Days 1 to 8, Days 14, 21, 28, Weeks 6, 8, 10, 12, Months 4, 5, 6, 12, 24, 36 and 48. However data for Days 8 and 28 is presented.
Time Frame Day 8 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
PD summary Population. Only those participants available at the specified time points were analyzed. Data for only quantifiable concentration is presented.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 0 17 0 0 0 0 0
Mean (Standard Deviation)
Unit of Measure: Percentage of lymphocytes
Baseline Number Analyzed 0 participants 0 participants 16 participants 0 participants 0 participants 0 participants 0 participants 0 participants
20.71  (25.324)
Day 8 Number Analyzed 0 participants 0 participants 17 participants 0 participants 0 participants 0 participants 0 participants 0 participants
22.08  (23.486)
Day 28 Number Analyzed 0 participants 0 participants 16 participants 0 participants 0 participants 0 participants 0 participants 0 participants
35.62  (28.538)
15.Secondary Outcome
Title Amounts of Cell-bound Otelixizumab on CD4+ and CD8+ T Cells
Hide Description Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Time Frame At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Hide Outcome Measure Data
Hide Analysis Population Description
PD summary Population. Data was not collected for this endpoint.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
16.Secondary Outcome
Title Saturation of CD4+ and CD8+ T Cells With Otelixizumab
Hide Description Samples were planned to analyze at the screening visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Time Frame At the screening visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Hide Outcome Measure Data
Hide Analysis Population Description
PD summary Population. Data was not collected for this endpoint.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title CD3/TCR Complexes on CD4+ and CD8+ T Cells
Hide Description Samples were planned to analyze at the Screen visit and at Baseline. Further on dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Time Frame At the Screen visit and at Baseline. On dose Day 1, at EOI and 4 hour post-SOI. On all other dosing days, at pre-dose, EOI and 4 hour post-SOI up to 48 months.
Hide Outcome Measure Data
Hide Analysis Population Description
PD summary Population. Data was not collected for this endpoint.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Number of Participants With Detectable Anti-otelixizumab Antiglobulin Response
Hide Description Anti-otelixizumab antibody levels were determined by ELISA. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.
Time Frame Up to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Immunogenicity data was not collected for Cohort 5 (5 day dosing) participants.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 0 19 7 9 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
   5.3%
0
   0.0%
0
   0.0%
2
  33.3%
0
   0.0%
19.Secondary Outcome
Title Number of Participants With Use of Analgesics, Antihistamines and IV Hydration as Concomitant Medication During Dosing Days
Hide Description Ibuprofen (analgesic) was given orally as follows: 400-800 mg 2 hour before SOI, 400-800 mg 2 hour after SOI, 400-800 mg 6 hour after SOI, and 400-800 mg at bedtime. If ibuprofen was contraindicated, acetaminophen was used in place of ibuprofen. Acetaminophen doses were adjusted so as it did not exceed 1000 mg per 6 hour or 4000 mg per day. A non-sedating antihistamine (cetirizine) was administered approximately 1 hour prior to each infusion of study drug. The recommended initial dose of cetirizine was 5 mg or 10 mg per day in adults and children aged 12 years and older. Normal saline solution was administered IV as needed to maintain hydration.
Time Frame Up to Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 8 15 18 19 7 9 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
Day 1, Analgesics Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
8
 100.0%
11
  73.3%
18
 100.0%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 1, Antihistamines Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
8
 100.0%
11
  73.3%
18
 100.0%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 1, IV Saline Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
6
  75.0%
13
  86.7%
13
  72.2%
16
  84.2%
3
  42.9%
3
  33.3%
3
  50.0%
5
  83.3%
Day 2, Analgesics Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
8
 100.0%
11
  73.3%
17
  94.4%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 2, Antihistamines Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
8
 100.0%
11
  73.3%
18
 100.0%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 2, IV Saline Number Analyzed 8 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
7
  87.5%
13
  86.7%
14
  77.8%
18
  94.7%
4
  57.1%
2
  22.2%
3
  50.0%
5
  83.3%
Day 3, Analgesics Number Analyzed 7 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
7
 100.0%
11
  73.3%
18
 100.0%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 3, Antihistamines Number Analyzed 7 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
7
 100.0%
11
  73.3%
18
 100.0%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 3, IV Saline Number Analyzed 7 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
6
  85.7%
13
  86.7%
14
  77.8%
17
  89.5%
4
  57.1%
3
  33.3%
3
  50.0%
5
  83.3%
Day 4, Analgesics Number Analyzed 5 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
5
 100.0%
11
  73.3%
18
 100.0%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 4, Antihistamines Number Analyzed 5 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
5
 100.0%
11
  73.3%
18
 100.0%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 4, IV Saline Number Analyzed 5 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
5
 100.0%
13
  86.7%
14
  77.8%
17
  89.5%
4
  57.1%
4
  44.4%
3
  50.0%
6
 100.0%
Day 5, Analgesics Number Analyzed 2 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
2
 100.0%
11
  73.3%
17
  94.4%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 5, Antihistamines Number Analyzed 2 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
2
 100.0%
11
  73.3%
17
  94.4%
18
  94.7%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 5, IV Saline Number Analyzed 2 participants 15 participants 18 participants 19 participants 7 participants 9 participants 6 participants 6 participants
2
 100.0%
13
  86.7%
14
  77.8%
17
  89.5%
4
  57.1%
5
  55.6%
2
  33.3%
6
 100.0%
Day 6, Analgesics Number Analyzed 1 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 6 participants
1
 100.0%
15
 100.0%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 6, Antihistamines Number Analyzed 1 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 6 participants
1
 100.0%
11
  73.3%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 6, IV Saline Number Analyzed 8 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 6 participants
0
   0.0%
13
  86.7%
17
  89.5%
4
  57.1%
3
  33.3%
2
  33.3%
6
 100.0%
Day 7, Analgesics Number Analyzed 0 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 6 participants
11
  73.3%
19
 100.0%
4
  57.1%
6
  66.7%
3
  50.0%
6
 100.0%
Day 7, Antihistamines Number Analyzed 0 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 6 participants
11
  73.3%
19
 100.0%
3
  42.9%
6
  66.7%
3
  50.0%
6
 100.0%
Day 7, IV Saline Number Analyzed 0 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 6 participants
14
  93.3%
18
  94.7%
4
  57.1%
3
  33.3%
3
  50.0%
6
 100.0%
Day 8, Analgesics Number Analyzed 0 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 5 participants
12
  80.0%
18
  94.7%
4
  57.1%
6
  66.7%
3
  50.0%
5
 100.0%
Day 8, Antihistamines Number Analyzed 0 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 5 participants
12
  80.0%
19
 100.0%
4
  57.1%
5
  55.6%
2
  33.3%
5
 100.0%
Day 8, IV Saline Number Analyzed 0 participants 15 participants 0 participants 19 participants 7 participants 9 participants 6 participants 5 participants
14
  93.3%
18
  94.7%
4
  57.1%
3
  33.3%
3
  50.0%
5
 100.0%
20.Secondary Outcome
Title Change From Baseline in Percent Glycosylated Hemoglobin (HbA1c)
Hide Description Participants were seen weekly during the first 4 weeks post-dose and then every other week through Week 12. After Week 12, visits occurred every 1 to 3 months through Month 18, which completes the Core Study up to Month 48 (follow up). Day 1 pre-dose value was considered as Baseline value. Change from Baseline was post-Baseline value minus Baseline value.
Time Frame Baseline and up to Month 48
Hide Outcome Measure Data
Hide Analysis Population Description
PD summary Population. Only those participants available at the specified time points were analyzed. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. Data for only quantifiable concentration is presented.
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description:
Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort.
Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days.
Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days.
Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days.
Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days.
Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
Overall Number of Participants Analyzed 0 14 17 18 7 9 6 4
Mean (Standard Deviation)
Unit of Measure: Percentage of glycosylated hemoglobin
Day 28 Number Analyzed 0 participants 13 participants 16 participants 17 participants 5 participants 7 participants 6 participants 4 participants
-0.58  (0.656) -0.44  (0.788) -0.41  (0.404) -0.44  (0.416) -0.60  (0.624) -0.88  (0.578) -0.53  (0.737)
Week 6 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 1 participants 0 participants
0.10 [1]   (NA) -0.20 [1]   (NA)
Week 8 Number Analyzed 0 participants 13 participants 16 participants 17 participants 6 participants 8 participants 6 participants 4 participants
-0.69  (0.825) -0.48  (1.187) -0.19  (0.749) -0.48  (0.618) -0.64  (0.838) -0.90  (1.277) -0.72  (1.124)
Week 10 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
-0.10 [1]   (NA)
Week 12 Number Analyzed 0 participants 13 participants 16 participants 17 participants 6 participants 7 participants 6 participants 4 participants
-0.35  (0.670) -0.15  (1.272) 0.19  (0.534) -0.37  (0.784) -0.64  (1.180) -0.55  (1.063) -0.30  (1.494)
Month 4 Number Analyzed 0 participants 12 participants 14 participants 16 participants 6 participants 7 participants 6 participants 4 participants
0.08  (0.890) 0.35  (1.575) 0.39  (0.545) -0.18  (1.061) 0.39  (1.497) -0.17  (1.124) 0.05  (1.196)
Month 5 Number Analyzed 0 participants 12 participants 15 participants 17 participants 6 participants 6 participants 6 participants 4 participants
0.10  (0.867) 0.76  (1.790) 0.42  (0.797) 0.13  (0.999) 0.63  (1.435) -0.07  (0.983) 0.55  (1.338)
Month 6 Number Analyzed 0 participants 12 participants 15 participants 17 participants 5 participants 7 participants 6 participants 4 participants
-0.23  (0.819) 0.43  (1.479) 0.22  (1.274) -0.28  (0.743) 0.61  (1.655) -0.25  (0.985) 0.00  (1.699)
Month 9 Number Analyzed 0 participants 12 participants 15 participants 17 participants 6 participants 7 participants 5 participants 4 participants
-0.43  (0.878) 1.03  (1.589) 0.26  (1.118) 0.10  (1.307) 0.19  (1.558) -0.64  (1.076) -0.00  (2.304)
Month 12 Number Analyzed 0 participants 10 participants 12 participants 17 participants 5 participants 6 participants 6 participants 4 participants
-0.27  (0.800) 1.31  (1.729) 0.36  (1.330) 0.90  (1.938) 0.90  (2.045) -0.23  (0.784) 0.35  (2.412)
Month 16 Number Analyzed 0 participants 9 participants 9 participants 14 participants 6 participants 7 participants 5 participants 3 participants
-0.36  (0.886) 0.93  (1.542) 0.45  (1.591) 0.20  (1.284) 1.33  (2.368) 0.06  (0.573) 0.00  (2.358)
Month 18 Number Analyzed 0 participants 9 participants 4 participants 13 participants 6 participants 7 participants 6 participants 4 participants
-0.24  (1.184) 0.27  (1.087) 0.58  (1.476) 0.15  (1.323) 1.06  (2.277) -0.33  (1.253) 0.42  (2.138)
Month 24 Number Analyzed 0 participants 10 participants 0 participants 12 participants 6 participants 7 participants 6 participants 3 participants
-0.32  (1.172) 0.31  (1.059) 0.38  (1.714) 1.66  (3.730) -0.25  (1.141) 0.20  (2.117)
Month 36 Number Analyzed 0 participants 8 participants 0 participants 10 participants 1 participants 6 participants 6 participants 0 participants
-0.21  (1.212) 0.85  (1.090) -0.10 [1]   (NA) 2.03  (3.063) -0.55  (1.677)
Month 48 Number Analyzed 0 participants 7 participants 0 participants 4 participants 0 participants 0 participants 0 participants 0 participants
-0.24  (0.648) 0.20  (1.254)
[1]
Only one participant was analyzed, hence no data.
Time Frame All SAEs and non-SAEs were collected up to Month 24
Adverse Event Reporting Description SAEs and non-SAEs were reported for All subjects Population. Participants from all 7 cohorts who had received a total dose <3.0 mg were analyzed as a separate treatment group. All other participants were analyzed according to the planned dose based on the cohort they belonged to.
 
Arm/Group Title Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Hide Arm/Group Description Participants from any of the 7 cohorts [3.1 mg, 3.1 mg (5 days), 4.35 mg, 4.35 mg (ITC-5), 4.35 mg (ITC-30), 6.85 mg and 8.85 mg] receiving a total Otelixizumab dose <3.0 mg during the study were analyzed in this cohort. Participants in cohort 1 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg and then 0.5 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. Participants in cohort 5 received one dose per day of Otelixizumab with doses 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg and 1.1 mg as IV infusion administered over 30 minutes for 5 consecutive days. Participants in cohort 2 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 mg x 5 as IV infusion administered over 2 hours for 8 consecutive days. Participants in ITC-15 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 15 minutes for 8 consecutive days. Participants in ITC-30 cohort received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, then 0.75 x 5 as IV infusion administered over 30 minutes for 8 consecutive days. Participants in cohort 3 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg and 1.75 mg as IV infusion administered over 2 hours for 8 consecutive days. Participants in cohort 4 received one dose per day of Otelixizumab with doses 0.1 mg, 0.2 mg, 0.3 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.50 mg and 3.75 mg as IV infusion administered over 2 hours for 8 consecutive days.
All-Cause Mortality
Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)   0/15 (0.00%)   0/18 (0.00%)   0/19 (0.00%)   0/7 (0.00%)   0/9 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/8 (12.50%)   2/15 (13.33%)   1/18 (5.56%)   0/19 (0.00%)   0/7 (0.00%)   1/9 (11.11%)   1/6 (16.67%)   2/6 (33.33%) 
Cardiac disorders                 
Coronary artery stenosis  1  0/8 (0.00%)  1/15 (6.67%)  0/18 (0.00%)  0/19 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Infections and infestations                 
Meningitis enteroviral  1  0/8 (0.00%)  0/15 (0.00%)  1/18 (5.56%)  0/19 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Urinary tract infection  1  1/8 (12.50%)  0/15 (0.00%)  0/18 (0.00%)  0/19 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications                 
Limb crushing injury  1  0/8 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/19 (0.00%)  0/7 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders                 
Diabetic ketoacidosis  1  0/8 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/19 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/6 (16.67%) 
Dehydration  1  0/8 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/19 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
Hyperglycaemia  1  0/8 (0.00%)  1/15 (6.67%)  0/18 (0.00%)  0/19 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                 
Breast cancer  1  0/8 (0.00%)  1/15 (6.67%)  0/18 (0.00%)  0/19 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/6 (0.00%) 
Nervous system disorders                 
Speech disorder  1  0/8 (0.00%)  0/15 (0.00%)  0/18 (0.00%)  0/19 (0.00%)  0/7 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/6 (16.67%) 
1
Term from vocabulary, MedDRA version 15.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Otelixizumab <3.0 mg Otelixizumab 3.1 mg Otelixizumab 3.1 mg (5 Days) Otelixizumab 4.35 mg Otelixizumab 4.35 mg (ITC-15) Otelixizumab 4.35 mg (ITC-30) Otelixizumab 6.85 mg Otelixizumab 8.85 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/8 (100.00%)   15/15 (100.00%)   18/18 (100.00%)   18/19 (94.74%)   7/7 (100.00%)   9/9 (100.00%)   6/6 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders                 
Anaemia  1