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Phase IIa Study of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT02738775
Recruitment Status : Completed
First Posted : April 14, 2016
Results First Posted : July 15, 2021
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
TG Therapeutics, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Multiple Sclerosis
Interventions Biological: Ublituximab
Drug: Placebo
Enrollment 49
Recruitment Details  
Pre-assignment Details A total of 49 participants were randomized in this study. One participant was treated with placebo only; 12 participants were treated with placebo prior to treatment with ublituximab.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description Participant received intravenous (IV) infusion of ublituximab 150 milligrams (mg)/4 hour (hr) on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Period Title: Overall Study
Started 8 8 8 9 8 8
Initially Treated With Placebo 0 0 0 1 0 0
Completed 8 6 8 8 8 7
Not Completed 0 2 0 1 0 1
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0
Adverse Event             0             0             0             1             0             0
Pregnancy             0             1             0             0             0             0
Missing             0             0             0             0             0             1
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Total
Hide Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Total of all reporting groups
Overall Number of Baseline Participants 8 8 8 8 8 8 48
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) population included all participants who received at least one dose of ublituximab.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 48 participants
42.4  (12.09) 34.3  (9.13) 44.9  (9.06) 35.1  (9.22) 43.5  (6.39) 36.5  (8.33) 39.4  (9.70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 48 participants
Female
5
  62.5%
6
  75.0%
5
  62.5%
5
  62.5%
8
 100.0%
3
  37.5%
32
  66.7%
Male
3
  37.5%
2
  25.0%
3
  37.5%
3
  37.5%
0
   0.0%
5
  62.5%
16
  33.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 48 participants
Hispanic or Latino
0
   0.0%
2
  25.0%
1
  12.5%
2
  25.0%
1
  12.5%
3
  37.5%
9
  18.8%
Not Hispanic or Latino
8
 100.0%
6
  75.0%
7
  87.5%
6
  75.0%
7
  87.5%
5
  62.5%
39
  81.3%
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%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants 48 participants
Black or African American 2 0 2 2 0 1 7
White 6 7 6 6 8 6 39
Other 0 1 0 0 0 1 2
1.Primary Outcome
Title Responder Rate of B-Cell Depletion at Week 4
Hide Description Responders Rate is defined as percentage of participants with greater than or equal to (≥) 95% reduction of B cells (cluster of differentiation 19 positive [CD19+] cells) within 2 weeks after the second infusion (Day 15).
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.5
(47.35 to 99.68)
100.0
(63.06 to 100)
87.5
(47.35 to 99.68)
100.0
(63.06 to 100)
100.0
(63.06 to 100)
100.0
(63.06 to 100)
2.Secondary Outcome
Title Number of New Gadolinium (Gd)-Enhancing T1 Lesions at Weeks 24 and 48
Hide Description The Gd-enhancing T1 lesions were evaluated using magnetic resonance imaging (MRI) technique.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 7 8 8 8 7
Mean (Standard Deviation)
Unit of Measure: lesions
Week 24 0.0  (0.00) 0.0  (0.00) 0.0  (0.00) 0.0  (0.00) 0.0  (0.00) 0.0  (0.00)
Week 48 0.0  (0.00) 0.0  (0.00) 0.0  (0.00) 0.0  (0.00) 0.0  (0.00) 0.0  (0.00)
3.Secondary Outcome
Title Number of New or Enlarging T2 Lesions at Weeks 24 and 48
Hide Description The new or enlarging T2 lesions were evaluated using MRI technique.
Time Frame Weeks 24 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab. Overall number of participants analyzed signifies participants who were evaluable for this outcome measure.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg / 3 hr on Day 1, 600 mg / 1 hr on Day 15 and 600 mg / 1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 7 8 8 8 7
Mean (Standard Deviation)
Unit of Measure: lesions
Week 24 0.38  (0.52) 0.29  (0.49) 0.00  (0.00) 0.25  (0.71) 0.00  (0.00) 0.14  (0.38)
Week 48 0.25  (0.71) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00) 0.00  (0.00)
4.Secondary Outcome
Title Annualized Relapse Rate (ARR)
Hide Description ARR at Week 48 is calculated as the ratio of the sum of all participants confirmed relapse counts divided by the sum of all participants treatment duration (in years).
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg / 1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Measure Type: Number
Unit of Measure: relapses per participant-years
0.28 0.00 0.14 0.14 0.00 0.00
5.Secondary Outcome
Title Relapse Rate Reduction (RRR)
Hide Description RRR was calculated as the percentage reduction from baseline ARR to ARR at Week 48.
Time Frame Baseline to Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Measure Type: Number
Unit of Measure: percentage reduction
75.55 100.00 87.80 89.04 100.00 100.00
6.Secondary Outcome
Title Percentage of Relapse Free Participants
Hide Description Participant was considered as free of clinical relapse if participant had no confirmed clinical relapse before treatment discontinuation/until end of Week 48. Relapses are defined as the occurrence of new or worsening neurological symptoms attributable to multiple sclerosis (MS), and immediately preceded by a stable or improving neurological state of at least 30 days.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg / 1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
75.0
(34.91 to 96.81)
100.0
(63.06 to 100)
87.5
(47.35 to 99.68)
87.5
(47.35 to 99.68)
100.0
(63.06 to 100)
100.0
(63.06 to 100)
7.Secondary Outcome
Title Change From Baseline in B Cells (CD19+), Memory (CD19+CD27+) and Naïve (CD19+CD27-[Negative]) B Cells
Hide Description Cluster of Differentiation (CD)19 is a marker of B cells, the protein has been used to diagnose cancers that arise from this type of cell - notably B cell lymphomas, acute lymphoblastic leukemia (ALL), and chronic lymphocytic leukemia (CLL). The majority of B cell malignancies express normal to high levels of CD19. Memory B cell is a type of B lymphocyte that forms part of the adaptive immune system. These cells develop within germinal centers of the secondary lymphoid organs. Their function is to memorize the characteristics of the antigen that activated their parent B cell during initial infection such that if the memory B cell later encounters the same antigen, it triggers an accelerated and robust secondary immune response. A naive B cell is a B cell that has not been exposed to an antigen. Once exposed to an antigen, the naive B cell either becomes a memory B cell or a plasma cell that secretes antibodies specific to the antigen that was originally bound.
Time Frame Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 plus 2 days, Weeks 25, 28, 36, 40, 44 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: percentage of cells
B Cells (CD19+): Baseline Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
7.40  (4.108) 7.89  (3.899) 7.24  (4.586) 8.11  (2.696) 5.71  (2.368) 6.78  (2.097)
B Cells (CD19+): Change from Baseline to Week 1 Day 2 Number Analyzed 8 participants 7 participants 7 participants 8 participants 8 participants 8 participants
-6.55  (3.920) -8.29  (3.850) -6.54  (4.715) -7.95  (2.719) -5.66  (2.347) -6.70  (2.123)
B Cells (CD19+): Change from Baseline to Week 2 Number Analyzed 7 participants 8 participants 8 participants 6 participants 8 participants 8 participants
-7.52  (3.175) -7.80  (3.878) -7.13  (4.617) -6.95  (1.806) -5.68  (2.362) -6.73  (2.090)
B Cells (CD19+): Change from Baseline to Week 3 Day 15 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
-7.27  (4.053) -7.80  (3.830) -7.17  (4.592) -8.03  (2.714) -5.69  (2.369) -6.72  (2.080)
B Cells (CD19+): Change from Baseline to Week 4 Number Analyzed 8 participants 8 participants 7 participants 8 participants 7 participants 8 participants
-7.28  (4.127) -7.79  (3.859) -6.82  (4.889) -8.03  (2.717) -6.03  (2.322) -6.71  (2.102)
B Cells (CD19+): Change from Baseline to Week 8 Number Analyzed 8 participants 8 participants 8 participants 7 participants 8 participants 8 participants
-7.29  (4.102) -7.79  (3.886) -7.15  (4.625) -8.03  (3.032) -5.69  (2.358) -6.70  (2.065)
B Cells (CD19+): Change from Baseline to Week 12 Number Analyzed 6 participants 8 participants 8 participants 7 participants 7 participants 7 participants
-7.47  (4.592) -7.77  (3.823) -7.17  (4.617) -8.45  (2.644) -5.35  (2.317) -7.14  (1.820)
B Cells (CD19+): Change from Baseline to Week 16 Number Analyzed 7 participants 7 participants 7 participants 8 participants 8 participants 7 participants
-7.01  (4.352) -7.53  (4.110) -7.75  (4.628) -7.83  (2.667) -5.68  (2.375) -6.89  (2.178)
B Cells (CD19+): Change from Baseline to Week 20 Number Analyzed 8 participants 6 participants 6 participants 8 participants 7 participants 8 participants
-7.23  (4.116) -8.07  (4.449) -7.18  (4.637) -7.58  (2.740) -5.70  (2.534) -6.65  (2.200)
B Cells (CD19+): Change from Baseline to Week 24 Number Analyzed 8 participants 8 participants 7 participants 7 participants 8 participants 6 participants
-7.21  (4.068) -7.53  (3.399) -7.76  (4.478) -7.39  (2.940) -5.65  (2.377) -5.62  (1.992)
B Cells (CD19+): Change from Baseline to Week 24 Plus 2 Days Number Analyzed 8 participants 6 participants 5 participants 7 participants 6 participants 5 participants
-7.31  (4.108) -6.45  (2.919) -7.98  (4.430) -7.88  (2.895) -6.29  (2.403) -7.47  (1.983)
B Cells (CD19+): Change from Baseline to Week 25 Number Analyzed 7 participants 7 participants 7 participants 8 participants 7 participants 5 participants
-6.45  (3.698) -8.20  (4.007) -7.88  (4.512) -8.06  (2.694) -5.57  (2.544) -7.47  (2.008)
B Cells (CD19+): Change from Baseline to Week 28 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 7 participants
-7.31  (4.106) -6.81  (2.844) -7.18  (4.597) -8.00  (2.699) -5.65  (2.360) -6.64  (2.258)
B Cells (CD19+): Change from Baseline to Week 36 Number Analyzed 8 participants 7 participants 8 participants 6 participants 7 participants 7 participants
-7.32  (4.082) -6.79  (2.820) -7.18  (4.601) -8.48  (2.905) -5.69  (2.530) -6.64  (2.255)
B Cells (CD19+): Change from Baseline to Week 40 Number Analyzed 5 participants 7 participants 8 participants 6 participants 8 participants 7 participants
-5.40  (3.828) -6.74  (2.838) -7.15  (4.567) -7.77  (3.132) -5.65  (2.343) -6.56  (2.299)
B Cells (CD19+): Change from Baseline to Week 44 Number Analyzed 8 participants 7 participants 8 participants 7 participants 8 participants 7 participants
-7.32  (4.092) -6.74  (2.801) -7.05  (4.546) -8.06  (2.860) -5.65  (2.341) -6.59  (2.296)
B Cells (CD19+): Change from Baseline to Week 48 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 5 participants
-7.25  (4.086) -6.71  (2.854) -6.87  (4.542) -7.73  (2.621) -5.67  (2.342) -7.39  (2.174)
Memory (CD19+CD27+): Baseline Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
0.38  (0.337) 0.92  (0.722) 0.90  (1.010) 0.68  (0.457) 0.88  (0.997) 0.60  (0.367)
Memory (CD19+CD27+): Change from Baseline to Week 1 Day 2 Number Analyzed 8 participants 7 participants 7 participants 8 participants 8 participants 8 participants
-0.28  (0.279) -0.92  (0.728) -0.90  (1.098) -0.59  (0.480) -0.85  (1.001) -0.54  (0.357)
Memory (CD19+CD27+): Change from Baseline to Week 2 Number Analyzed 7 participants 8 participants 8 participants 6 participants 8 participants 8 participants
-0.32  (0.354) -0.86  (0.713) -0.83  (1.032) -0.46  (0.411) -0.86  (1.003) -0.57  (0.357)
Memory (CD19+CD27+): Change from Baseline to Week 3 Day 15 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
-0.31  (0.285) -0.86  (0.694) -0.86  (1.007) -0.63  (0.468) -0.87  (1.001) -0.57  (0.382)
Memory (CD19+CD27+): Change from Baseline to Week 4 Number Analyzed 8 participants 8 participants 7 participants 8 participants 7 participants 8 participants
-0.31  (0.347) -0.85  (0.690) -0.64  (0.910) -0.64  (0.465) -0.91  (1.072) -0.55  (0.396)
Memory (CD19+CD27+): Change from Baseline to Week 8 Number Analyzed 8 participants 8 participants 8 participants 7 participants 8 participants 8 participants
-0.32  (0.331) -0.86  (0.736) -0.85  (1.030) -0.64  (0.552) -0.87  (0.994) -0.55  (0.381)
Memory (CD19+CD27+): Change from Baseline to Week 12 Number Analyzed 6 participants 8 participants 8 participants 7 participants 7 participants 7 participants
-0.36  (0.364) -0.83  (0.668) -0.87  (1.019) -0.69  (0.494) -0.92  (1.068) -0.60  (0.381)
Memory (CD19+CD27+): Change from Baseline to Week 16 Number Analyzed 7 participants 7 participants 7 participants 8 participants 8 participants 7 participants
-0.30  (0.355) -0.92  (0.769) -0.93  (1.068) -0.65  (0.456) -0.87  (1.004) -0.56  (0.427)
Memory (CD19+CD27+): Change from Baseline to Week 20 Number Analyzed 8 participants 6 participants 6 participants 8 participants 7 participants 8 participants
-0.27  (0.335) -0.86  (0.849) -1.07  (1.101) -0.64  (0.431) -0.88  (1.064) -0.52  (0.421)
Memory (CD19+CD27+): Change from Baseline to Week 24 Number Analyzed 8 participants 8 participants 7 participants 7 participants 8 participants 6 participants
-0.30  (0.340) -0.84  (0.656) -0.96  (1.038) -0.69  (0.442) -0.86  (1.007) -0.59  (0.444)
Memory (CD19+CD27+): Change from Baseline to Week 24 Plus 2 Days Number Analyzed 8 participants 6 participants 5 participants 7 participants 6 participants 5 participants
-0.34  (0.330) -0.74  (0.434) -0.76  (0.875) -0.59  (0.469) -0.91  (1.168) -0.65  (0.469)
Memory (CD19+CD27+): Change from Baseline to Week 25 Number Analyzed 7 participants 7 participants 7 participants 8 participants 7 participants 6 participants
-0.28  (0.371) -0.97  (0.738) -0.98  (1.057) -0.65  (0.465) -0.95  (1.033) -0.61  (0.404)
Memory (CD19+CD27+): Change from Baseline to Week 28 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 7 participants
-0.34  (0.336) -0.68  (0.442) -0.87  (1.021) -0.62  (0.508) -0.85  (0.971) -0.60  (0.368)
Memory (CD19+CD27+): Change from Baseline to Week 36 Number Analyzed 8 participants 7 participants 8 participants 6 participants 7 participants 7 participants
-0.34  (0.322) -0.68  (0.436) -0.87  (1.020) -0.75  (0.495) -0.88  (1.069) -0.59  (0.400)
Memory (CD19+CD27+): Change from Baseline to Week 40 Number Analyzed 5 participants 7 participants 8 participants 6 participants 8 participants 7 participants
-0.20  (0.086) -0.68  (0.441) -0.86  (1.012) -0.62  (0.450) -0.85  (0.975) -0.57  (0.424)
Memory (CD19+CD27+): Change from Baseline to Week 44 Number Analyzed 8 participants 7 participants 8 participants 7 participants 8 participants 6 participants
-0.34  (0.341) -0.66  (0.429) -0.85  (0.997) -0.69  (0.462) -0.85  (1.008) -0.62  (0.444)
Memory (CD19+CD27+): Change from Baseline to Week 48 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 5 participants
-0.32  (0.344) -0.65  (0.463) -0.83  (0.983) -0.62  (0.433) -0.86  (1.007) -0.71  (0.414)
Naïve (CD19+CD27-): Baseline Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
6.92  (3.837) 7.30  (3.188) 6.26  (4.043) 7.00  (2.135) 4.73  (2.206) 6.11  (2.096)
Naïve (CD19+CD27-): Change from Baseline to Week 1 Day 2 Number Analyzed 8 participants 7 participants 7 participants 8 participants 8 participants 8 participants
-6.18  (3.665) -7.29  (3.427) -5.56  (3.954) -6.93  (2.132) -4.72  (2.203) -6.09  (2.100)
Naïve (CD19+CD27-): Change from Baseline to Week 2 Number Analyzed 7 participants 8 participants 8 participants 6 participants 8 participants 8 participants
-7.09  (2.899) -7.27  (3.177) -6.23  (4.058) -6.18  (1.723) -4.73  (2.205) -6.10  (2.089)
Naïve (CD19+CD27-): Change from Baseline to Week 3 Day 15 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
-6.86  (3.805) -7.27  (3.161) -6.23  (4.043) -6.97  (2.137) -4.73  (2.205) -6.09  (2.081)
Naïve (CD19+CD27-): Change from Baseline to Week 4 Number Analyzed 8 participants 8 participants 7 participants 8 participants 7 participants 8 participants
-6.87  (3.836) -7.26  (3.173) -6.13  (4.342) -6.96  (2.134) -5.02  (2.211) -6.09  (2.092)
Naïve (CD19+CD27-): Change from Baseline to Week 8 Number Analyzed 8 participants 8 participants 8 participants 7 participants 8 participants 8 participants
-6.88  (3.831) -7.26  (3.173) -6.22  (4.057) -6.99  (2.322) -4.73  (2.203) -6.08  (2.093)
Naïve (CD19+CD27-): Change from Baseline to Week 12 Number Analyzed 6 participants 8 participants 8 participants 7 participants 7 participants 7 participants
-7.00  (4.287) -7.26  (3.175) -6.23  (4.061) -7.29  (2.060) -4.36  (2.100) -6.47  (1.907)
Naïve (CD19+CD27-): Change from Baseline to Week 16 Number Analyzed 7 participants 7 participants 7 participants 8 participants 8 participants 7 participants
-6.61  (4.067) -7.00  (3.341) -6.74  (4.085) -6.76  (2.098) -4.73  (2.209) -6.27  (2.184)
Naïve (CD19+CD27-): Change from Baseline to Week 20 Number Analyzed 8 participants 6 participants 6 participants 8 participants 7 participants 8 participants
-6.87  (3.828) -7.67  (3.234) -6.02  (3.994) -6.52  (2.214) -4.73  (2.377) -6.06  (2.139)
Naïve (CD19+CD27-): Change from Baseline to Week 24 Number Analyzed 8 participants 8 participants 7 participants 7 participants 8 participants 6 participants
-6.81  (3.788) -7.02  (2.809) -6.71  (4.024) -6.26  (2.275) -4.71  (2.207) -4.96  (1.658)
Naïve (CD19+CD27-): Change from Baseline to Week 24 Plus 2 Days Number Analyzed 8 participants 6 participants 5 participants 7 participants 6 participants 5 participants
-6.87  (3.842) -6.18  (2.666) -7.15  (4.231) -6.81  (2.272) -5.28  (2.286) -6.74  (2.156)
Naïve (CD19+CD27-): Change from Baseline to Week 25 Number Analyzed 7 participants 7 participants 7 participants 8 participants 7 participants 5 participants
-6.13  (3.473) -7.61  (3.257) -6.81  (4.012) -6.98  (2.132) -4.52  (2.305) -6.74  (2.148)
Naïve (CD19+CD27-): Change from Baseline to Week 28 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 7 participants
-6.87  (3.837) -6.53  (2.612) -6.24  (4.047) -6.95  (2.139) -4.71  (2.208) -5.97  (2.235)
Naïve (CD19+CD27-): Change from Baseline to Week 36 Number Analyzed 8 participants 7 participants 8 participants 6 participants 7 participants 7 participants
-6.89  (3.830) -6.52  (2.594) -6.23  (4.051) -7.22  (2.249) -4.72  (2.374) -5.97  (2.233)
Naïve (CD19+CD27-): Change from Baseline to Week 40 Number Analyzed 5 participants 7 participants 8 participants 6 participants 8 participants 7 participants
-5.18  (3.740) -6.46  (2.565) -6.21  (4.042) -6.63  (2.419) -4.72  (2.204) -5.92  (2.266)
Naïve (CD19+CD27-): Change from Baseline to Week 44 Number Analyzed 8 participants 7 participants 8 participants 7 participants 8 participants 7 participants
-6.89  (3.831) -6.48  (2.573) -6.13  (4.050) -6.98  (2.283) -4.72  (2.204) -5.94  (2.248)
Naïve (CD19+CD27-): Change from Baseline to Week 48 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 5 participants
-6.83  (3.809) -6.46  (2.580) -5.96  (4.091) -6.69  (2.060) -4.73  (2.205) -6.60  (2.292)
8.Secondary Outcome
Title Change From Baseline in Sustained B Cell
Hide Description Sustained B cell reduction is defined as B-cell reductions achieved on pre-dose at Week 24 and Week 48.
Time Frame Baseline to pre-dose at Week 24 and Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: percentage of cells
Baseline Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
7.40  (4.108) 7.89  (3.899) 7.24  (4.586) 8.11  (2.696) 5.71  (2.368) 6.78  (2.097)
Change at Pre-dose at Week 24 Number Analyzed 8 participants 8 participants 7 participants 7 participants 8 participants 6 participants
-7.21  (4.068) -7.53  (3.399) -7.76  (4.478) -7.39  (2.940) -5.65  (2.377) -5.62  (1.992)
Change at Pre-dose at Week 48 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 5 participants
-7.25  (4.086) -6.71  (2.854) -6.87  (4.542) -7.73  (2.621) -5.67  (2.342) -7.39  (2.174)
9.Secondary Outcome
Title Additional Immune Profiling-CD4+ (Cluster of Differentiation 4 Positive)
Hide Description A blood sample was collected and was sent to the laboratory for analysis of CD4+.
Time Frame Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: cells per cubic millimeter (cells/mm^3)
Baseline Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
28.73  (12.195) 35.39  (4.628) 24.34  (12.877) 25.75  (6.874) 22.70  (9.488) 22.27  (10.588)
Week 1 Day 2 Number Analyzed 8 participants 7 participants 7 participants 8 participants 8 participants 8 participants
22.71  (15.829) 27.52  (11.388) 19.51  (9.129) 16.98  (11.624) 16.49  (13.985) 14.15  (5.911)
Week 2 Number Analyzed 7 participants 8 participants 8 participants 6 participants 8 participants 8 participants
34.01  (7.190) 39.83  (8.829) 33.31  (4.862) 36.51  (9.289) 28.50  (8.173) 25.69  (8.761)
Week 3 Day 15 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 8 participants
23.74  (11.399) 26.51  (10.650) 22.60  (7.766) 27.68  (13.656) 19.88  (13.902) 24.57  (11.080)
Week 4 Number Analyzed 8 participants 8 participants 8 participants 8 participants 7 participants 8 participants
26.19  (11.922) 35.31  (11.530) 31.47  (8.658) 30.97  (12.840) 24.62  (8.087) 27.59  (11.016)
Week 8 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
29.74  (15.735) 31.46  (8.387) 29.64  (8.204) 30.95  (14.625) 27.73  (9.162) 24.59  (4.511)
Week 12 Number Analyzed 6 participants 8 participants 8 participants 8 participants 8 participants 7 participants
24.20  (8.152) 32.26  (7.118) 30.98  (11.476) 27.71  (9.209) 28.03  (12.045) 24.09  (8.087)
Week 16 Number Analyzed 7 participants 7 participants 7 participants 8 participants 8 participants 7 participants
24.03  (10.040) 31.55  (7.557) 19.19  (10.466) 31.27  (12.131) 27.37  (14.733) 17.85  (4.155)
Week 20 Number Analyzed 8 participants 6 participants 6 participants 8 participants 7 participants 8 participants
22.94  (9.492) 26.87  (11.629) 34.25  (8.928) 33.56  (8.537) 27.17  (7.908) 24.51  (13.149)
Week 24 Number Analyzed 8 participants 8 participants 7 participants 7 participants 8 participants 6 participants
29.24  (8.678) 29.36  (8.856) 31.33  (13.406) 29.12  (7.006) 26.71  (9.603) 17.41  (7.523)
Week 24 Plus 2 Days Number Analyzed 8 participants 6 participants 5 participants 7 participants 6 participants 5 participants
26.25  (8.120) 27.54  (5.269) 22.82  (17.385) 36.47  (12.548) 23.59  (6.912) 21.22  (8.474)
Week 25 Number Analyzed 7 participants 6 participants 7 participants 8 participants 7 participants 5 participants
30.70  (8.594) 27.31  (13.091) 35.42  (8.854) 28.46  (9.801) 27.96  (6.024) 17.57  (10.438)
Week 28 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 7 participants
20.03  (11.870) 31.70  (13.654) 29.71  (13.051) 23.57  (10.565) 23.09  (8.855) 21.64  (14.610)
Week 36 Number Analyzed 8 participants 7 participants 8 participants 7 participants 7 participants 7 participants
26.79  (14.209) 28.06  (9.436) 37.56  (8.664) 22.86  (8.413) 14.73  (5.916) 28.20  (15.386)
Week 40 Number Analyzed 5 participants 7 participants 8 participants 6 participants 8 participants 7 participants
25.31  (10.664) 30.91  (10.601) 28.45  (11.497) 28.10  (9.464) 18.17  (11.192) 26.68  (17.744)
Week 44 Number Analyzed 8 participants 7 participants 8 participants 7 participants 7 participants 7 participants
24.77  (6.469) 29.84  (9.013) 29.83  (10.774) 17.17  (9.920) 26.22  (14.340) 28.24  (12.190)
Week 48 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 5 participants
26.72  (6.914) 32.92  (6.697) 21.90  (7.779) 22.60  (8.935) 30.85  (13.016) 27.03  (7.844)
10.Secondary Outcome
Title Additional Immune Profiling-CD8+ (Cluster of Differentiation 8 Positive)
Hide Description A blood sample was collected and was sent to the laboratory for analysis of CD8+.
Time Frame Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: cells/mm^3
Baseline Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
16.80  (5.324) 17.50  (5.222) 9.97  (4.877) 12.25  (2.374) 8.72  (3.590) 12.83  (6.576)
Week 1 Day 2 Number Analyzed 8 participants 7 participants 7 participants 8 participants 8 participants 8 participants
10.04  (6.698) 12.06  (6.524) 6.87  (2.746) 5.93  (2.748) 5.14  (2.779) 7.61  (5.157)
Week 2 Number Analyzed 7 participants 8 participants 8 participants 6 participants 8 participants 8 participants
17.03  (3.654) 16.96  (7.869) 13.22  (3.141) 14.68  (2.377) 11.14  (4.767) 14.22  (9.157)
Week 3 Day 15 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 8 participants
12.14  (6.646) 11.88  (6.580) 9.21  (4.780) 12.10  (6.033) 7.22  (4.103) 12.50  (6.536)
Week 4 Number Analyzed 8 participants 8 participants 8 participants 8 participants 7 participants 8 participants
13.89  (5.715) 14.89  (7.815) 11.78  (3.263) 13.70  (5.296) 9.89  (2.120) 13.49  (5.214)
Week 8 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
15.92  (8.489) 13.91  (5.074) 10.97  (3.012) 12.80  (7.567) 9.63  (3.056) 12.62  (5.613)
Week 12 Number Analyzed 6 participants 8 participants 8 participants 8 participants 7 participants 7 participants
15.21  (8.122) 17.21  (6.807) 11.83  (5.397) 11.06  (3.773) 8.93  (4.185) 14.87  (9.608)
Week 16 Number Analyzed 7 participants 7 participants 7 participants 8 participants 8 participants 7 participants
16.25  (6.951) 13.87  (7.431) 6.76  (3.613) 12.51  (3.827) 10.63  (6.203) 10.86  (5.193)
Week 20 Number Analyzed 8 participants 6 participants 6 participants 8 participants 7 participants 8 participants
15.04  (7.197) 10.35  (5.998) 10.04  (3.132) 13.71  (3.450) 10.29  (5.150) 12.98  (7.476)
Week 24 Number Analyzed 8 participants 8 participants 7 participants 7 participants 8 participants 6 participants
15.83  (4.047) 13.77  (5.509) 11.59  (5.417) 12.22  (5.372) 12.05  (6.859) 9.45  (6.093)
Week 24 Plus 2 Days Number Analyzed 8 participants 6 participants 5 participants 7 participants 6 participants 5 participants
14.70  (3.655) 13.28  (6.727) 7.05  (4.656) 15.52  (5.839) 8.90  (1.508) 9.41  (3.298)
Week 25 Number Analyzed 7 participants 6 participants 7 participants 8 participants 7 participants 5 participants
15.38  (6.717) 12.48  (4.475) 12.07  (4.773) 11.60  (4.172) 9.78  (2.395) 8.94  (6.287)
Week 28 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 7 participants
11.15  (4.599) 12.84  (5.522) 10.63  (6.617) 11.02  (3.030) 9.32  (2.121) 9.71  (3.160)
Week 36 Number Analyzed 8 participants 7 participants 8 participants 7 participants 7 participants 7 participants
12.92  (7.721) 11.95  (5.493) 12.46  (2.840) 10.11  (4.527) 6.92  (3.158) 11.59  (2.584)
Week 40 Number Analyzed 5 participants 7 participants 8 participants 6 participants 8 participants 7 participants
14.63  (3.687) 12.77  (7.654) 9.82  (3.926) 11.59  (4.485) 7.93  (2.207) 10.30  (4.027)
Week 44 Number Analyzed 8 participants 7 participants 8 participants 7 participants 7 participants 7 participants
14.41  (6.085) 11.46  (2.451) 9.91  (3.937) 8.67  (5.073) 9.59  (3.922) 11.87  (3.352)
Week 48 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 5 participants
13.28  (6.673) 12.79  (5.232) 7.42  (2.276) 9.86  (5.260) 11.68  (5.757) 13.50  (3.412)
11.Secondary Outcome
Title Additional Immune Profiling-Interleukin 10 (IL10)
Hide Description A blood sample was collected and was sent to the laboratory for analysis of IL-10. IL-10 is an anti-inflammatory cytokine that maintains the balance of the immune response, allowing the clearance of infection while minimizing damage to the host.
Time Frame Baseline, Weeks 2, 4, 12, 20, 24, 25, 36, 44 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: picogram per milliliter (pg/ml)
Baseline Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
0.25  (0.175) 0.37  (0.343) 0.41  (0.459) 0.40  (0.247) 0.13  (0.129) 0.09  (0.120)
Week 2 Number Analyzed 7 participants 6 participants 7 participants 6 participants 8 participants 7 participants
0.39  (0.258) 0.39  (0.350) 0.27  (0.184) 0.42  (0.070) 0.16  (0.143) 0.07  (0.120)
Week 4 Number Analyzed 8 participants 6 participants 6 participants 7 participants 7 participants 7 participants
0.53  (0.294) 0.42  (0.290) 0.40  (0.286) 0.34  (0.135) 0.62  (1.059) 0.25  (0.358)
Week 12 Number Analyzed 5 participants 7 participants 8 participants 8 participants 7 participants 7 participants
0.57  (0.599) 0.89  (1.223) 0.70  (0.783) 0.26  (0.422) 0.04  (0.028) 1.19  (1.147)
Week 20 Number Analyzed 7 participants 6 participants 6 participants 8 participants 7 participants 7 participants
0.24  (0.160) 0.65  (0.631) 0.24  (0.141) 0.13  (0.213) 0.57  (0.467) 0.64  (0.593)
Week 24 Number Analyzed 8 participants 7 participants 7 participants 8 participants 8 participants 6 participants
0.43  (0.454) 0.45  (0.363) 0.49  (0.635) 0.29  (0.325) 2.14  (3.329) 0.91  (0.778)
Week 25 Number Analyzed 4 participants 7 participants 5 participants 7 participants 5 participants 4 participants
0.32  (0.163) 0.40  (0.237) 0.18  (0.292) 0.24  (0.237) 1.31  (1.168) 1.36  (0.922)
Week 36 Number Analyzed 7 participants 7 participants 8 participants 7 participants 7 participants 6 participants
0.21  (0.124) 0.36  (0.543) 0.08  (0.068) 0.79  (0.769) 0.95  (0.535) 0.82  (0.303)
Week 44 Number Analyzed 8 participants 7 participants 8 participants 7 participants 8 participants 7 participants
0.15  (0.164) 0.35  (0.715) 2.77  (3.101) 1.25  (1.268) 0.65  (0.452) 2.11  (1.533)
Week 48 Number Analyzed 8 participants 7 participants 7 participants 8 participants 8 participants 5 participants
0.07  (0.063) 0.44  (0.551) 1.87  (1.465) 3.13  (5.552) 0.68  (0.773) 1.23  (0.568)
12.Secondary Outcome
Title Additional Immune Profiling-Natural Killer (NK) Cells
Hide Description A blood sample was collected and was sent to the laboratory for analysis of NK cells. Percentage of NK cells per ml of blood. NK cells are lymphocytes with the ability to kill tumor cells without deliberate immunization or activation.
Time Frame Baseline, Week 1 Day 2, Week 2, Week 3 Day 15, Weeks 4, 8, 12, 16, 20, 24, Week 24 Plus 2 Days, Weeks 25, 28, 36, 40, 44 and 48
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who received at least one dose of ublituximab. 'Number analyzed' signifies participants who were evaluable for this outcome measure at the specified timepoint.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 8 8 8 8 8 8
Mean (Standard Deviation)
Unit of Measure: percentage of cells/mL
Baseline Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
6.53  (2.829) 7.22  (4.469) 5.06  (2.618) 7.68  (3.724) 5.04  (2.719) 4.67  (1.946)
Week 1 Day 2 Number Analyzed 8 participants 7 participants 7 participants 8 participants 8 participants 8 participants
1.98  (1.597) 2.01  (2.465) 2.11  (1.386) 1.38  (0.680) 1.10  (0.372) 1.08  (0.980)
Week 2 Number Analyzed 7 participants 8 participants 8 participants 6 participants 8 participants 8 participants
7.34  (6.862) 6.03  (5.001) 6.27  (1.230) 7.93  (2.861) 6.17  (3.588) 4.09  (1.920)
Week 3 Day 15 Number Analyzed 8 participants 8 participants 8 participants 8 participants 8 participants 8 participants
4.99  (1.647) 6.62  (5.840) 5.63  (2.792) 5.93  (4.679) 3.50  (1.717) 4.40  (2.570)
Week 4 Number Analyzed 8 participants 8 participants 7 participants 8 participants 7 participants 8 participants
6.45  (3.189) 7.88  (8.131) 7.49  (2.242) 5.72  (2.458) 6.12  (5.440) 4.80  (3.352)
Week 8 Number Analyzed 8 participants 8 participants 8 participants 7 participants 8 participants 8 participants
6.22  (4.761) 7.53  (4.347) 6.79  (4.172) 4.80  (2.463) 4.81  (2.573) 6.21  (4.520)
Week 12 Number Analyzed 6 participants 8 participants 8 participants 7 participants 7 participants 7 participants
5.47  (2.114) 6.33  (3.053) 6.71  (2.328) 5.25  (2.494) 3.46  (1.469) 5.71  (2.446)
Week 16 Number Analyzed 7 participants 7 participants 7 participants 8 participants 8 participants 7 participants
10.49  (5.747) 5.28  (2.548) 5.91  (3.136) 5.34  (3.057) 5.58  (4.578) 7.34  (6.747)
Week 20 Number Analyzed 8 participants 6 participants 6 participants 8 participants 7 participants 8 participants
10.17  (7.791) 4.46  (2.638) 6.81  (4.994) 5.73  (2.105) 5.79  (3.144) 8.03  (7.391)
Week 24 Number Analyzed 8 participants 8 participants 7 participants 7 participants 8 participants 6 participants
6.70  (4.883) 6.51  (3.781) 5.84  (2.890) 4.55  (2.243) 8.51  (5.484) 9.81  (3.968)
Week 24 Plus 2 Days Number Analyzed 8 participants 6 participants 5 participants 7 participants 6 participants 5 participants
8.31  (9.513) 4.45  (4.072) 3.75  (2.422) 3.38  (1.684) 5.83  (3.711) 4.97  (1.110)
Week 25 Number Analyzed 7 participants 7 participants 7 participants 8 participants 7 participants 5 participants
11.45  (6.599) 6.56  (4.849) 5.91  (3.133) 3.71  (2.199) 6.51  (3.541) 8.34  (5.602)
Week 28 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 7 participants
8.06  (7.674) 5.47  (4.326) 5.69  (3.218) 4.73  (3.334) 8.29  (5.664) 6.95  (2.970)
Week 36 Number Analyzed 8 participants 7 participants 8 participants 6 participants 7 participants 7 participants
6.63  (3.648) 6.36  (7.256) 5.72  (1.275) 7.88  (5.515) 8.22  (5.772) 9.58  (7.535)
Week 40 Number Analyzed 5 participants 7 participants 8 participants 6 participants 8 participants 7 participants
9.17  (4.527) 4.67  (3.109) 5.20  (2.904) 6.18  (2.901) 6.64  (3.070) 6.90  (3.244)
Week 44 Number Analyzed 8 participants 7 participants 8 participants 7 participants 8 participants 7 participants
7.20  (7.764) 4.40  (3.481) 5.00  (1.733) 8.97  (6.008) 6.59  (4.777) 7.14  (3.195)
Week 48 Number Analyzed 8 participants 7 participants 8 participants 8 participants 8 participants 5 participants
3.84  (2.081) 5.23  (4.943) 6.72  (1.960) 6.94  (3.601) 7.05  (4.446) 6.10  (1.930)
13.Secondary Outcome
Title Pharmacokinetic Parameter: Plasma Concentration of Ublituximab
Hide Description Plasma concentration is defined as the measured concentration of ublituximab.
Time Frame Day 1 (pre-dose); Week 2; Day 15 (pre-dose); Weeks 4, 24 (pre-dose) and 25
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure is not reported here because as per pre-specified plan, the analysis includes pooled data from participants enrolled in multiple studies including those who were not enrolled in this study.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg /3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab.
Overall Number of Participants Analyzed 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the first dose of study medication through the end of the study (Up to 48 weeks)
Adverse Event Reporting Description Safety Population included all participants who received at least one dose of ublituximab. Participants who received Placebo in any Cohort are combined for safety analysis.
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Placebo
Hide Arm/Group Description Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/3 hr on Day 15 and 450 mg/1.5 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /3 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1.5 hr on Day 15 and 450 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1.5 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/4 hr on Day 1, 450 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /4 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg / 3 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /3 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/2 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /2 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of ublituximab 150 mg/1 hr on Day 1, 600 mg/1 hr on Day 15 and 600 mg/1 hr on Week 24. Some participants initially received placebo IV infusion /1 hr on Day 1 and /1 hr on Day 15 before receiving ublituximab. Participant received IV infusion of placebo on Day 1 and Day 15.
All-Cause Mortality
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Placebo
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%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/8 (0.00%)   0/13 (0.00%) 
Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Placebo
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%)   1/8 (12.50%)   2/8 (25.00%)   0/8 (0.00%)   0/8 (0.00%)   2/8 (25.00%)   0/13 (0.00%) 
Gastrointestinal disorders               
Diverticulum  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Hepatobiliary disorders               
Cholelithiasis  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Infections and infestations               
Appendicitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Nervous system disorders               
Seizure  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Pregnancy, puerperium and perinatal conditions               
Pregnancy  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Social circumstances               
Pregnancy of partner  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Placebo
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%)   7/8 (87.50%)   8/8 (100.00%)   8/8 (100.00%)   8/8 (100.00%)   8/8 (100.00%)   12/13 (92.31%) 
Blood and lymphatic system disorders               
Lymph node pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Cardiac disorders               
Angina pectoris  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Coronary artery disease  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Cyanosis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Ear and labyrinth disorders               
Vertigo  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Ear pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Eustachian tube dysfunction  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Eye disorders               
Vision blurred  1  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Blepharospasm  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Dacryostenosis acquired  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Eye inflammation  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Eye pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Eyelid oedema  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Visual impairment  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Gastrointestinal disorders               
Nausea  1  0/8 (0.00%)  3/8 (37.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  5/8 (62.50%)  2/13 (15.38%) 
Diarrhoea  1  1/8 (12.50%)  0/8 (0.00%)  2/8 (25.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Vomiting  1  1/8 (12.50%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  2/13 (15.38%) 
Constipation  1  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Dysphagia  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  3/8 (37.50%)  0/8 (0.00%)  2/13 (15.38%) 
Abdominal pain upper  1  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/13 (15.38%) 
Dyspepsia  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Abdominal discomfort  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  1/13 (7.69%) 
Toothache  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Abdominal pain  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Abdominal pain lower  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Dry mouth  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Food poisoning  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Gastritis  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
General disorders               
Fatigue  1  0/8 (0.00%)  3/8 (37.50%)  2/8 (25.00%)  4/8 (50.00%)  2/8 (25.00%)  3/8 (37.50%)  5/13 (38.46%) 
Pyrexia  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  2/8 (25.00%)  1/13 (7.69%) 
Pain  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/13 (7.69%) 
Chills  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Asthenia  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Influenza like illness  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Infusion site pain  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Mass  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Temperature intolerance  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Immune system disorders               
Seasonal allergy  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Infections and infestations               
Upper respiratory tract infection  1  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  3/8 (37.50%)  0/8 (0.00%)  1/13 (7.69%) 
Influenza  1  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  2/8 (25.00%)  0/8 (0.00%)  2/13 (15.38%) 
Sinusitis  1  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  3/8 (37.50%)  0/8 (0.00%)  0/8 (0.00%)  2/13 (15.38%) 
Nasopharyngitis  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  3/8 (37.50%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Fungal infection  1  1/8 (12.50%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Urinary tract infection  1  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Conjunctivitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Oral herpes  1  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Vulvovaginal mycotic infection  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Body tinea  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/13 (7.69%) 
Bronchitis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Bursitis infective  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Ear infection  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Gastroenteritis viral  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Kidney infection  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Laryngitis  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Localised infection  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Pneumonia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Staphylococcal infection  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Tooth infection  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Injury, poisoning and procedural complications               
Infusion related reaction  1  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  3/8 (37.50%)  1/8 (12.50%)  3/13 (23.08%) 
Contusion  1  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Fall  1  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Skin laceration  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Skin abrasion  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Wrist fracture  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Investigations               
White blood cell count decreased  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Blood creatinine increased  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Heart rate abnormal  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Heart rate increased  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Influenza B virus test positive  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Metabolism and nutrition disorders               
Dehydration  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Hypercholesterolaemia  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Vitamin B12 deficiency  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Vitamin D deficiency  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders               
Arthralgia  1  1/8 (12.50%)  2/8 (25.00%)  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  1/13 (7.69%) 
Back pain  1  3/8 (37.50%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Muscle spasms  1  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Musculoskeletal pain  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Muscle tightness  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Neck pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Pain in extremity  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Musculoskeletal stiffness  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Joint swelling  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Muscle twitching  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Muscular weakness  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Musculoskeletal chest pain  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)               
Melanocytic naevus  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Papilloma  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Nervous system disorders               
Headache  1  2/8 (25.00%)  3/8 (37.50%)  1/8 (12.50%)  2/8 (25.00%)  2/8 (25.00%)  2/8 (25.00%)  2/13 (15.38%) 
Hypoaesthesia  1  2/8 (25.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  3/8 (37.50%)  1/13 (7.69%) 
Dizziness  1  0/8 (0.00%)  3/8 (37.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  3/8 (37.50%)  3/13 (23.08%) 
Migraine  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Memory impairment  1  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Carpal tunnel syndrome  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Neuropathy peripheral  1  2/8 (25.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Tremor  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Sensory loss  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/13 (7.69%) 
Uhthoffs phenomenon  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Amnesia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Burning sensation  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Cognitive disorder  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Facial paralysis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Lethargy  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Multiple sclerosis relapse  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Muscle spasticity  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Myelitis transverse  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Neuralgia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Nystagmus  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Occipital neuralgia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Paraesthesia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/13 (7.69%) 
Sensory disturbance  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Vibratory sense increased  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Psychiatric disorders               
Depression  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Insomnia  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Mood swings  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Somnambulism  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Stress  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Renal and urinary disorders               
Bladder pain  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Dysuria  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Hypertonic bladder  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Reproductive system and breast disorders               
Menorrhagia  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Adenomyosis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Vaginal odour  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Throat irritation  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/8 (12.50%)  3/8 (37.50%)  0/8 (0.00%)  2/13 (15.38%) 
Cough  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  1/13 (7.69%) 
Oropharyngeal pain  1  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Dyspnoea  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/13 (15.38%) 
Rhinorrhoea  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/8 (12.50%)  0/8 (0.00%)  1/13 (7.69%) 
Asthma  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Dry throat  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Pulmonary congestion  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Sinus congestion  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Upper respiratory tract congestion  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Skin and subcutaneous tissue disorders               
Rash  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  2/8 (25.00%)  0/8 (0.00%)  1/13 (7.69%) 
Pruritus  1  0/8 (0.00%)  0/8 (0.00%)  2/8 (25.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Nail discolouration  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Dermatitis contact  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/13 (0.00%) 
Dry skin  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
Ecchymosis  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Eczema  1  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Psoriasis  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Rosacea  1  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Skin lesion  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  1/13 (7.69%) 
Vascular disorders               
Flushing  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  2/8 (25.00%)  1/13 (7.69%) 
Haematoma  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/13 (7.69%) 
Hot flush  1  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/13 (0.00%) 
Hypertension  1  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  0/8 (0.00%)  1/8 (12.50%)  0/8 (0.00%)  0/13 (0.00%) 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: TG Therapeutics Clinical Support Team
Organization: TG Therapeutics
Phone: 1-877-575-8489
EMail: clinicalsupport@tgtxinc.com
Layout table for additonal information
Responsible Party: TG Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02738775    
Other Study ID Numbers: TG1101-RMS-201
First Submitted: April 10, 2016
First Posted: April 14, 2016
Results First Submitted: June 22, 2021
Results First Posted: July 15, 2021
Last Update Posted: July 15, 2021