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Trial record 3 of 4 for:    KHK4083

Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

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: NCT02647866
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : March 5, 2020
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Kyowa Kirin, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Ulcerative Colitis
Digestive System Diseases
Colitis, Ulcerative
Colitis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Colonic Diseases
Autoimmune Disease
Abdominal Pain
Interventions Drug: KHK4083
Drug: Placebo
Enrollment 66
Recruitment Details Investigative sites in the US, Poland, Czech Republic, Russia, Romania, Serbia, and Hungary screened patients from January 2016 until June 2017, with the first patient enrolled in June 2016.
Pre-assignment Details A total of 109 patients were screened during the recruiting period. Subjects were enrolled into the study only if all inclusion criteria and none of the exclusion criteria were fulfilled.
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 Placebo
Hide Arm/Group Description Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Period Title: Overall Study
Started 9 10 9 21 17
Completed Induction Therapy 8 [1] 9 [2] 8 [3] 19 [4] 17 [5]
Completed Induction Therapy Follow-Up 5 1 2 0 2
Completed Long-Term Extension Therapy 3 [6] 0 0 0 0
Completed LTE Follow-up 2 0 0 0 0
Completed Open-Label Extension Therapy 0 7 [7] 4 [8] 17 [8] 13 [8]
Completed OLE Follow-up 0 6 4 14 10
Moved From LTE to OLE Therapy 0 5 0 0 2
Discontinued the Treatment 4 5 5 5 8
Discontinued the Study 5 4 5 6 8
Completed 4 6 4 15 9
Not Completed 5 4 5 6 8
Reason Not Completed
Adverse Event             0             0             2             2             1
Disease Worsening             3             1             0             0             1
Withdrawal by Subject             1             1             2             4             4
Physician Decision             0             1             1             0             2
Death             0             1             0             0             0
Subject moved to different country             1             0             0             0             0
[1]
Subjects received KHK4083 1.0 mg/kg for 12 weeks
[2]
Subjects received KHK4083 3.0 mg/kg for 12 weeks
[3]
Subjects received KHK4083 10.0 mg/kg for 12 weeks
[4]
Subjects received the maximum tolerated dose of KHK4083 10.0 mg/kg for 12 weeks
[5]
Subjects received Placebo for 12 weeks
[6]
10 add'l treatments of KHK4083 (same dose as Induction Therapy) as maintenance therapy.
[7]
10 add'l treatments of Open-Label KHK4083 (same dose as Induction Therapy) as maintenance therapy.
[8]
10 add'l treatments of Open-Label KHK4083 (same dose as Induction Therapy) as maintenance therapy
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 Placebo Total
Hide Arm/Group Description Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo. Total of all reporting groups
Overall Number of Baseline Participants 9 10 9 21 17 66
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 9 participants 21 participants 17 participants 66 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  77.8%
8
  80.0%
9
 100.0%
19
  90.5%
17
 100.0%
60
  90.9%
>=65 years
2
  22.2%
2
  20.0%
0
   0.0%
2
   9.5%
0
   0.0%
6
   9.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 9 participants 10 participants 9 participants 21 participants 17 participants 66 participants
47.3
(18 to 67)
46.1
(21 to 75)
41.2
(18 to 63)
41.1
(18 to 78)
33.8
(18 to 61)
40.8
(18 to 78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 9 participants 21 participants 17 participants 66 participants
Female
4
  44.4%
2
  20.0%
5
  55.6%
6
  28.6%
8
  47.1%
25
  37.9%
Male
5
  55.6%
8
  80.0%
4
  44.4%
15
  71.4%
9
  52.9%
41
  62.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 9 participants 21 participants 17 participants 66 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
9
 100.0%
10
 100.0%
9
 100.0%
21
 100.0%
17
 100.0%
66
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 10 participants 9 participants 21 participants 17 participants 66 participants
American Indian or Alaska Native
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%
Native Hawaiian or Other Pacific Islander
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%
0
   0.0%
0
   0.0%
1
   5.9%
1
   1.5%
White
9
 100.0%
10
 100.0%
9
 100.0%
21
 100.0%
16
  94.1%
65
  98.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Subjects With Treatment-related Adverse Events
Hide Description To determine the safety and tolerability of KHK4083
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - All randomized subjects who received any (even partial dose) investigational product (KHK4083 or placebo).
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
Overall Number of Participants Analyzed 9 10 9 21 49 17
Measure Type: Count of Participants
Unit of Measure: Participants
With Any TEAE
5
  55.6%
7
  70.0%
7
  77.8%
14
  66.7%
33
  67.3%
13
  76.5%
With Any Drug-related TEAE
3
  33.3%
2
  20.0%
3
  33.3%
3
  14.3%
11
  22.4%
2
  11.8%
With Any TEAE with an Outcome of Death
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
2.Primary Outcome
Title Number of Subjects With Treatment-related Serious Adverse Events
Hide Description To determine the safety and tolerability of KHK4083
Time Frame Up to 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set - All randomized subjects who received any (even partial dose) investigational product (KHK4083 or placebo).
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who received KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 9 10 9 21 49 17
Measure Type: Count of Participants
Unit of Measure: Participants
With Any Serious TEAE
1
  11.1%
1
  10.0%
1
  11.1%
3
  14.3%
6
  12.2%
3
  17.6%
With Any Drug-related Serious TEAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Who Died
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
3.Primary Outcome
Title Number of Subjects Who Show Improvement in the Mucosa at Week 12
Hide Description Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 22 37 15
Measure Type: Count of Participants
Unit of Measure: Participants
mMES Improvement
2
  28.6%
4
  50.0%
9
  40.9%
15
  40.5%
5
  33.3%
Modified Baron Endoscopic Score Improvement
3
  42.9%
5
  62.5%
8
  36.4%
16
  43.2%
6
  40.0%
4.Primary Outcome
Title Proportion of Subjects Who Show Improvement in the Mucosa at Week 52
Hide Description Measured by the modified Mayo endoscopy sub-score (mMES), which ranges from 0-3 with higher scores = more severe disease.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy,
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 21 36 14
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
3
  37.5%
9
  42.9%
13
  36.1%
4
  28.6%
5.Secondary Outcome
Title Number of Subjects With Confirmed Anti-KHK4083 Antibodies (Immunogenicity)
Hide Description The immunogenicity was assessed by determination of the development of anti-drug antibodies (ADA) against KHK4083.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received at least one dose of KHK4083, including 14 subjects initially randomized to placebo and who then continued into Open-Label Extension therapy, where they received the maximum tolerated dose of KHK4083.
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one maximum tolerated dose (10.0 mg/kg) IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 9 10 9 21 14
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with Pre-Existing ADA at Baseline
1
  11.1%
2
  20.0%
1
  11.1%
0
   0.0%
1
   7.1%
Subjects with Production of Treatment-Induced ADA
3
  33.3%
0
   0.0%
1
  11.1%
5
  23.8%
4
  28.6%
6.Secondary Outcome
Title Number of Subjects Who Achieve Mucosal Healing at Week 12
Hide Description The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1 at Week 12.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 22 37 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
3
  37.5%
8
  36.4%
12
  32.4%
4
  26.7%
7.Secondary Outcome
Title Number of Subjects Who Achieve Mucosal Healing at Week 52
Hide Description The endoscopic Mayo Score (Mayo endoscopic subscore) evaluates ulcerative colitis stage, based only on endoscopic exploration. The scale ranges from 0 to 3, with higher scores = more severe activity. Mucosal healing is defined as modified Mayo endoscopy sub-score (mMES) of 0 or 1.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 21 36 14
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
3
  37.5%
7
  33.3%
11
  30.6%
3
  21.4%
8.Secondary Outcome
Title Number of Subjects Who Achieve Clinical Improvement at Week 12
Hide Description The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement will be based on a reduction in the total Mayo Clinic score.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 22 37 15
Measure Type: Count of Participants
Unit of Measure: Participants
2
  28.6%
4
  50.0%
9
  40.9%
15
  40.5%
5
  33.3%
9.Secondary Outcome
Title Change From Baseline in Total Mayo Scale Score at Week 52
Hide Description The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Improvement was based on a reduction (mean change from Baseline [Week 0] to Week 52) in the total Mayo Clinic score.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description

The overall number of participants is the number in the full analysis set. The number of patients analyzed is the number of patients who had values at the noted visits.

There were no subjects in the 10.0 mg/kg KHK4083 group in the LTE Therapy Period. There were no subjects in the 1.0 mg/kg KHK4083 group in the OLE Therapy Period.

Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 22 37 15
Mean (Standard Deviation)
Unit of Measure: score on a scale
LTE Period - Baseline Score Number Analyzed 3 participants 5 participants 0 participants 8 participants 2 participants
8.0  (0.0) 7.8  (0.8) 7.9  (0.6) 7.5  (2.1)
LTE Period - Week 52 Score Number Analyzed 2 participants 0 participants 0 participants 2 participants 0 participants
2.5  (2.1) 2.5  (2.1)
LTE Period - Week 52 Change from Baseline Number Analyzed 2 participants 0 participants 0 participants 2 participants 0 participants
-5.5  (2.1) -5.5  (2.1)
OLE Period - Baseline Score Number Analyzed 0 participants 8 participants 21 participants 29 participants 14 participants
7.6  (1.1) 7.8  (1.5) 7.8  (1.4) 7.6  (0.9)
OLE Period - Week 52 Score Number Analyzed 0 participants 6 participants 19 participants 25 participants 8 participants
3.7  (3.1) 3.6  (2.4) 3.6  (2.5) 4.3  (3.4)
OLE Period - Week 52 Change from Baseline Number Analyzed 0 participants 6 participants 19 participants 25 participants 8 participants
-4.0  (2.4) -4.4  (2.7) -4.3  (2.5) -3.5  (2.8)
10.Secondary Outcome
Title Number of Subjects Who Achieve a Clinical Response at Week 12
Hide Description The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response is a reduction in the total Mayo Clinic score of at least 3 points.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set - All randomized subjects who received at least one full dose of investigational product and had a Baseline and at least one post-treatment primary efficacy variable.
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 22 37 15
Measure Type: Count of Participants
Unit of Measure: Participants
3
  42.9%
8
 100.0%
11
  50.0%
22
  59.5%
9
  60.0%
11.Secondary Outcome
Title Number of Subjects Who Achieve a Clinical Response at Week 52
Hide Description The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical Response indicates the change from Baseline in the Total Mayo Clinic score <= -3 and the percentage change from Baseline in the Total Mayo Clinic score <= -30% to Week 12, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of <= 1.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 21 36 14
Measure Type: Count of Participants
Unit of Measure: Participants
2
  28.6%
4
  50.0%
14
  66.7%
20
  55.6%
5
  35.7%
12.Secondary Outcome
Title Number of Subjects Who Achieve Clinical Remission at Week 12
Hide Description The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores > 1.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 22 37 15
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
3
  37.5%
6
  27.3%
10
  27.0%
3
  20.0%
13.Secondary Outcome
Title Number of Subjects Who Achieve Clinical Remission at Week 52
Hide Description The Mayo Clinic Score is comprised of 4 parts: stool frequency, rectal bleeding, endoscopic findings and physician's global assessment, each scored from 0-3. The total score ranges from 0-12 with higher scores indicating increased severity of disease. Clinical remission is defined as a total Mayo Clinic score of ≤ 2 and no subscores > 1.
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohorts 3 + 4 Combined KHK4083 Combined Placebo
Hide Arm/Group Description:
Subjects received one 1.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 3.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
Subjects received one 10.0 mg/kg IV infusion treatment of KHK4083 every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48.
The total number of participants analyzed who were randomized to KHK4083 during Induction Therapy.
Subjects received one IV infusion treatment of Placebo every two weeks from Week 0 to Week 10 of Induction Therapy. Subjects who chose to continue into extension therapy and were eligible received one IV infusion every 4 weeks (at the same dose as Induction Therapy) from Week 12 to Week 48. Subjects who participated in Open-Label Therapy received KHK4083 instead of placebo.
Overall Number of Participants Analyzed 7 8 21 36 14
Measure Type: Count of Participants
Unit of Measure: Participants
1
  14.3%
3
  37.5%
6
  28.6%
10
  27.8%
5
  35.7%
Time Frame 52 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 KHK4083 Combined Placebo
Hide Arm/Group Description Subjects who qualify will receive 1.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. Subjects who qualify will receive 3.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. Subjects who qualify will receive 10.0 mg/kg IV infusion treatments of KHK4083 from Baseline to Week 48. Subjects who qualify will receive maximum tolerated dose (10.0 mg/kg) IV infusion treatments of KHK4083 from Baseline to Week 48. The total number of participants analyzed who were randomized to KHK4083 during Treatment parts A & B. Subjects received placebo IV infusion treatments from Baseline to Week 12. Subjects who completed double-blind Induction Therapy (i.e., at least five of six treatments) were eligible to enter OLE Therapy and receive 10 treatments of open-label KHK4083 (at the same dose administered to that subject during Induction Therapy) as maintenance therapy. Each subject was to receive one IV infusion every 4 weeks from Week 12 to Week 48.
All-Cause Mortality
KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 KHK4083 Combined Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/9 (0.00%)      1/10 (10.00%)      0/9 (0.00%)      0/21 (0.00%)      1/49 (2.04%)      0/17 (0.00%)    
Hide Serious Adverse Events
KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 KHK4083 Combined Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      1/10 (10.00%)      1/9 (11.11%)      3/21 (14.29%)      6/49 (12.24%)      3/17 (17.65%)    
Blood and lymphatic system disorders             
Anaemia  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  2
Cardiac disorders             
Myocardial infarction  1  0/9 (0.00%)  0 1/10 (10.00%)  2 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  2 0/17 (0.00%)  0
Gastrointestinal disorders             
Colitis  1  1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Colitis ulcerative  1  1/9 (11.11%)  2 0/10 (0.00%)  0 1/9 (11.11%)  1 1/21 (4.76%)  1 3/49 (6.12%)  4 0/17 (0.00%)  0
Hepatobiliary disorders             
Hepatotoxicity  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 0/17 (0.00%)  0
Infections and infestations             
Clostridium difficile infection  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/21 (4.76%)  1 1/49 (2.04%)  1 1/17 (5.88%)  1
Pneumonia  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/21 (4.76%)  1 1/49 (2.04%)  1 0/17 (0.00%)  0
Post procedural infection  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/21 (4.76%)  1 1/49 (2.04%)  1 0/17 (0.00%)  0
Pyelonephritis  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Investigations             
Blood albumin decreased  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/21 (4.76%)  1 1/49 (2.04%)  1 0/17 (0.00%)  0
Surgical and medical procedures             
Abscess drainage  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
KHK4083 Cohort 1 KHK4083 Cohort 2 KHK4083 Cohort 3 KHK4083 Cohort 4 KHK4083 Combined Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/9 (55.56%)      7/10 (70.00%)      7/9 (77.78%)      13/21 (61.90%)      32/49 (65.31%)      13/17 (76.47%)    
Blood and lymphatic system disorders             
Anaemia  1  2/9 (22.22%)  2 2/10 (20.00%)  2 0/9 (0.00%)  0 3/21 (14.29%)  3 7/49 (14.29%)  7 3/17 (17.65%)  4
Lymphopenia  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 1/21 (4.76%)  1 2/49 (4.08%)  2 1/17 (5.88%)  1
Thrombocytosis  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Cardiac disorders             
Sinus bradycardia  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/21 (0.00%)  0 0/49 (0.00%)  0 0/17 (0.00%)  0
Congenital, familial and genetic disorders             
Renal aplasia  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Gastrointestinal disorders             
Abdominal distension  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 0/17 (0.00%)  0
Abdominal pain  1  0/9 (0.00%)  0 3/10 (30.00%)  3 0/9 (0.00%)  0 0/21 (0.00%)  0 3/49 (6.12%)  3 1/17 (5.88%)  1
Abdominal pain lower  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Abdominal pain upper  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Abdominal tenderness  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Colitis ulcerative  1  1/9 (11.11%)  1 1/10 (10.00%)  1 1/9 (11.11%)  1 2/21 (9.52%)  2 5/49 (10.20%)  5 5/17 (29.41%)  5
Diarrhoea  1  0/9 (0.00%)  0 1/10 (10.00%)  2 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  2 0/17 (0.00%)  0
Flatulence  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Gastrooesophageal reflux disease  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Haemorrhoidal haemorrhage  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Haemorrhoids  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Mouth ulceration  1  1/9 (11.11%)  1 0/10 (0.00%)  0 1/9 (11.11%)  1 0/21 (0.00%)  0 2/49 (4.08%)  2 0/17 (0.00%)  0
Mucous stools  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Nausea  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 1/17 (5.88%)  1
Vomiting  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
General disorders             
Asthenia  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Chest discomfort  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Chills  1  1/9 (11.11%)  1 1/10 (10.00%)  1 0/9 (0.00%)  0 1/21 (4.76%)  1 3/49 (6.12%)  3 0/17 (0.00%)  0
Pyrexia  1  3/9 (33.33%)  3 1/10 (10.00%)  1 1/9 (11.11%)  1 1/21 (4.76%)  1 6/49 (12.24%)  6 0/17 (0.00%)  0
Hepatobiliary disorders             
Hepatic steatosis  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Infections and infestations             
Influenza  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Oral candidiasis  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Oral herpes  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Pharyngitis  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/21 (4.76%)  1 1/49 (2.04%)  1 1/17 (5.88%)  1
Sinusitis  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 1/21 (4.76%)  1 2/49 (4.08%)  2 0/17 (0.00%)  0
Tonsillitis  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Urinary tract infection  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 1/21 (4.76%)  1 1/49 (2.04%)  1 1/17 (5.88%)  1
Viral upper respiratory tract infection  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Injury, poisoning and procedural complications             
Arthropod bite  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Scar  1  1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Investigations             
Alanine aminotransferase increased  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Amylase increased  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Aspartate aminotransferase abnormal  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 2/17 (11.76%)  2
Aspartate aminotransferase increased  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 2/17 (11.76%)  2
Blood creatine phosphokinase abnormal  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Blood creatine phosphokinase increased  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 1/21 (4.76%)  2 2/49 (4.08%)  3 1/17 (5.88%)  1
Blood folate decreased  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
C-reactive protein increased  1  1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Lipase increased  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders             
Arthralgia  1  2/9 (22.22%)  2 0/10 (0.00%)  0 0/9 (0.00%)  0 1/21 (4.76%)  1 3/49 (6.12%)  3 1/17 (5.88%)  1
Joint swelling  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Muscular weakness  1  0/9 (0.00%)  0 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 0/49 (0.00%)  0 1/17 (5.88%)  1
Myalgia  1  1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 1/17 (5.88%)  1
Nervous system disorders             
Headache  1  0/9 (0.00%)  0 1/10 (10.00%)  1 1/9 (11.11%)  1 0/21 (0.00%)  0 2/49 (4.08%)  2 1/17 (5.88%)  1
Paraesthesia  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Psychiatric disorders             
Anxiety  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  0/9 (0.00%)  0 0/10 (0.00%)  0 1/9 (11.11%)  1 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Oropharyageal pain  1  1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Sneezing  1  0/9 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
Skin and subcutaneous tissue disorders             
Pruritis  1  1/9 (11.11%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0 0/21 (0.00%)  0 1/49 (2.04%)  1 0/17 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Kyowa Kirin Pharmaceutical Development
Organization: Kyowa Kirin Pharmaceutical Development
Phone: 609-919-1100
EMail: kkd.clintrial.82@kyowakirin.com
Layout table for additonal information
Responsible Party: Kyowa Kirin, Inc.
ClinicalTrials.gov Identifier: NCT02647866    
Other Study ID Numbers: 4083-002
First Submitted: December 8, 2015
First Posted: January 6, 2016
Results First Submitted: January 9, 2020
Results First Posted: March 5, 2020
Last Update Posted: March 5, 2020