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Trial record 2 of 2 for:    medi2070 | Crohn Disease | Italy
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Evaluation of Efficacy and Safety of Brazikumab (MEDI2070) in Participants With Active, Moderate to Severe Crohn's Disease

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ClinicalTrials.gov Identifier: NCT02574637
Recruitment Status : Terminated (Study was terminated for business reasons; not due to safety or efficacy concerns.)
First Posted : October 14, 2015
Results First Posted : May 15, 2020
Last Update Posted : May 15, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Crohn's Disease
Interventions Drug: Brazikumab IV Infusion
Drug: Brazikumab SC Injection
Drug: Placebo
Enrollment 29
Recruitment Details  
Pre-assignment Details The study enrolled 29 participants who were randomized to one of five treatment groups (Placebo/ Brazikumab High dose/ Brazikumab High-Medium dose/ Brazikumab Low dose/ Brazikumab Low-Medium dose). This study was terminated early.
Arm/Group Title Double Blind (DB): Placebo DB: Brazikumab High Dose DB: Brazikumab High-Medium Dose DB: Brazikumab Low-Medium Dose DB: Brazikumab Low Dose Open-label (OL): Placebo/Brazikumab 210 mg OL: Brazikumab High Dose/Brazikumab 210 mg OL: Brazikumab High- Medium Dose/Brazikumab 210 mg OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low Dose/Brazikumab 210 mg
Hide Arm/Group Description Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks at Weeks 8 and 12 in the induction phase and Weeks 16, 20 and 24 in the maintenance phase. Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received placebo-matching brazikumab in the double-blind treatment period. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high dose of brazikumab in the double-blind treatment period. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high-medium dose of brazikumab in the double-blind treatment period. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low-medium dose of brazikumab in the double-blind treatment period. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low dose of brazikumab in the double-blind treatment period.
Period Title: Double-blind Period
Started 5 5 9 7 3 0 0 0 0 0
Completed 2 4 2 3 1 0 0 0 0 0
Not Completed 3 1 7 4 2 0 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0             0             0             0             0             0
Lack of Efficacy             0             0             2             0             0             0             0             0             0             0
Protocol Deviation             1             0             0             0             0             0             0             0             0             0
Non-Compliance With Study Drug             0             0             0             1             0             0             0             0             0             0
Study Terminated By Sponsor             1             1             5             2             2             0             0             0             0             0
Reason Not Specified             0             0             0             1             0             0             0             0             0             0
Period Title: Open-label (OL) Period
Started 0 0 0 0 0 2 3 2 3 1
Completed 0 0 0 0 0 0 1 1 1 0
Not Completed 0 0 0 0 0 2 2 1 2 1
Reason Not Completed
Adverse Event             0             0             0             0             0             0             0             0             1             0
Withdrawal by Subject             0             0             0             0             0             1             0             0             0             1
Study Terminated By Sponsor             0             0             0             0             0             1             2             1             1             0
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose Total
Hide Arm/Group Description Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period. Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48. Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48. Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period. Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period. Total of all reporting groups
Overall Number of Baseline Participants 4 5 9 7 3 28
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 5 participants 9 participants 7 participants 3 participants 28 participants
35.3  (10.34) 37.2  (13.29) 38.3  (15.03) 39.9  (13.89) 40.7  (11.37) 38.3  (12.66)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants 7 participants 3 participants 28 participants
Female
2
  50.0%
3
  60.0%
6
  66.7%
4
  57.1%
1
  33.3%
16
  57.1%
Male
2
  50.0%
2
  40.0%
3
  33.3%
3
  42.9%
2
  66.7%
12
  42.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants 7 participants 3 participants 28 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
2
  28.6%
0
   0.0%
2
   7.1%
Not Hispanic or Latino
4
 100.0%
5
 100.0%
8
  88.9%
5
  71.4%
3
 100.0%
25
  89.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  11.1%
0
   0.0%
0
   0.0%
1
   3.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants 7 participants 3 participants 28 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
1
  25.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
2
   7.1%
White
3
  75.0%
5
 100.0%
8
  88.9%
6
  85.7%
3
 100.0%
25
  89.3%
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%
1
  11.1%
0
   0.0%
0
   0.0%
1
   3.6%
1.Primary Outcome
Title Percentage of Participants With Crohn's Disease Activity Index (CDAI) Remission at Week 8
Hide Description CDAI remission was defined as a CDAI score of <150 at Week 8. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
0.0 0.0 22.2 0.0 33.3
2.Secondary Outcome
Title Percentage of Participants With Loose/Liquid Stool Frequency Response
Hide Description Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.
Time Frame Baseline, Weeks 8, 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period. Participant with missing data for this outcome measure was imputed as a non-responder.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 50.0 40.0 55.6 14.3 66.7
Week 16 50.0 60.0 66.7 0.0 33.3
Week 28 25.0 20.0 33.3 0.0 33.3
3.Secondary Outcome
Title Percentage of Participants With Crohn's Disease Activity Index (CDAI) Response
Hide Description CDAI response was defined as a decrease from baseline in the CDAI score of ≥100. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame Baseline, Weeks 8, 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period. Participant with missing data for this outcome measure was imputed as a non-responder.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 0.0 60.0 77.8 28.6 66.7
Week 16 25.0 60.0 55.6 14.3 33.3
Week 28 0.0 50.0 11.1 14.3 33.3
4.Secondary Outcome
Title Percentage of Participants With CDAI Clinical Remission
Hide Description CDAI clinical remission was defined as a CDAI score of <150. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=none to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature, and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame Weeks 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 25.5 20.0 22.2 14.3 33.3
Week 28 25.0 0.0 0.0 0.0 33.3
5.Secondary Outcome
Title Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Response
Hide Description SES-CD response was defined as a decrease from baseline in SES-CD score of ≥ 50%. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.
Time Frame Baseline, Weeks 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period. Participant with missing data for this outcome measure was imputed as a non-responder.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 0.0 40.0 44.4 14.3 0.0
Week 28 0.0 40.0 11.1 14.3 33.3
6.Secondary Outcome
Title Percentage of Participants With Loose/Liquid Stool Frequency Remission
Hide Description Loose/liquid stool frequency response is the stools identified as Type 6 or 7 on Bristol Stool Form Scale, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline. The participant recorded their stool consistency each day in a daily patient diary using the Bristol Stool Form Scale. It is a scale between 1-7, it measured the shape of the stool, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool.
Time Frame Baseline, Weeks 8, 16 and 28
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Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period. Participant with missing data for this outcome measure was imputed as a non-responder.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 75.0 60.0 55.6 28.6 100.0
Week 16 50.0 60.0 55.6 14.3 66.7
Weeks 28 50.0 20.0 33.3 14.3 33.3
7.Secondary Outcome
Title Percentage of Participants With Simple Endoscopic Score for Crohn's Disease (SES-CD) Remission
Hide Description SES-CD remission was defined as a Total SES-CD score of ≤4 and no subscore >2. The SES-CD evaluates 4 endoscopic variables [ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis] each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy [ileum, right colon, transverse colon, left colon, and rectum]. The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 60, where higher scores indicates more severe disease.
Time Frame Weeks 16 and 28
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Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period. Participant with missing data for this outcome measure was imputed as a non-responder.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 16 0.0 20.0 22.2 0.0 0.0
Week 28 0.0 20.0 11.1 0.0 0.0
8.Secondary Outcome
Title Percentage of Participants With Patient Response Outcome-2 (PRO2) Remission
Hide Description PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain (on an 11-point scale where 0=no pain to 10=worst imaginable pain). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO2-remission was defined as PRO2 less than 8 points. PRO2 is a composite index consisting of weighted scoring of both variables. PRO2 scores ranges from 0 to approximately 45, higher score indicates higher disease activity.
Time Frame Weeks 8, 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 0.0 20.0 11.1 0.0 0.0
Week 16 0.0 20.0 0.0 0.0 0.0
Week 28 25.0 0.0 11.1 0.0 0.0
9.Secondary Outcome
Title Percentage of Participants With PRO2 Response
Hide Description PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools and abdominal pain. PRO2 response was defined as remission or response in one symptom (either abdominal pain or stool frequency) plus response in the other: a) abdominal pain remission: On an 11-point (0 to 10) pain scale: During 1 week, no daily score > 2, b) abdominal pain response: On an 11-point (0 to 10) pain scale: ≥ 30% reduction in weekly pain score from baseline, c) loose/liquid stool frequency remission: Counting stools identified as Type 6 or 7 on Bristol Stool Form Scale (BSFS), (The BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool), during 1 week, each daily loose/liquid stool count ≤ 3, d) loose/liquid stool frequency response: Counting stools identified as Type 6 or 7 on BSFS, ≥ 30% reduction in weekly loose/liquid stool count compared to baseline.
Time Frame Baseline, Weeks 8, 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 50.0 20.0 33.3 0.0 66.7
Week 16 50.0 40.0 66.7 0.0 66.7
Week 28 50.0 0.0 33.3 0.0 33.3
10.Secondary Outcome
Title Serum Interleukin (IL)-22 and Serum Lipocalin 2 (LCN2) Concentration as a Biomarker of Brazikumab's Efficacy
Hide Description [Not Specified]
Time Frame Weeks 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Data for predictive biomarker analysis was not collected due to small number of participants available for analysis.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Percentage of Participants With CDAI Modified Sustained Clinical Remission at Both Weeks 8 and 28
Hide Description CDAI modified sustained clinical remission was defined as a CDAI score of <150 at both Weeks 8 and 28. CDAI score was calculated by summing weighted scores for subjective items [number of liquid or very soft stools, abdominal pain (on a scale of 0=mild to 3=severe) and general well-being (on a scale of 1=generally well to 4=terrible)] recorded by a diary during a 1-week period, and objective items [associated symptoms, taking antidiarrheal agents such as loperamide/opiates, abdominal mass, hematocrit, daily morning temperature and body weight]. CDAI scores range from 0 to approximately 600 points, higher score indicates higher disease activity.
Time Frame Weeks 8 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected for this endpoint.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Serum Brazikumab Concentration
Hide Description [Not Specified]
Time Frame Predose at Weeks 0, 1, 4, 8, 12, 16, 28; Postdose at Weeks 0 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) population included all participants who received at least 1 dose of investigational product and had at least 1 PK sample containing quantifiable brazikumab. Number analyzed is number of participants with evaluable data at given time-point.
Arm/Group Title Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 5 9 7 3
Mean (Standard Deviation)
Unit of Measure: nanograms per milliliters (ng/mL)
Week 0, Predose Number Analyzed 5 participants 9 participants 7 participants 3 participants
307  (686) 3213  (9639) 7  (19) 0  (0)
Week 0, Postdose Number Analyzed 4 participants 7 participants 6 participants 3 participants
448085  (151153) 149388  (75443) 0  (0) 0  (0)
Week 1, Predose Number Analyzed 5 participants 9 participants 7 participants 3 participants
124239  (19941) 51335  (16422) 20740  (10744) 14073  (5896)
Week 4, Predose Number Analyzed 5 participants 7 participants 7 participants 3 participants
56798  (25064) 17741  (4622) 11201  (6084) 5290  (266)
Week 4, Postdose Number Analyzed 4 participants 8 participants 7 participants 3 participants
390820  (60355) 17252  (10812) 11383  (5853) 7555  (4178)
Week 8, Predose Number Analyzed 5 participants 9 participants 6 participants 3 participants
77747  (30129) 13997  (4467) 10850  (4191) 7982  (5967)
Week 12, Predose Number Analyzed 5 participants 9 participants 7 participants 3 participants
50667  (16704) 19076  (11823) 11554  (4505) 6031  (3528)
Week 16, Predose Number Analyzed 5 participants 7 participants 5 participants 3 participants
33247  (12890) 26321  (16994) 13920  (5340) 6404  (1768)
Week 28, Predose Number Analyzed 2 participants 2 participants 3 participants 1 participants
31067  (8738) 13713  (2072) 10842  (6641) 6988 [1]   (NA)
[1]
Standard deviation (SD) was not estimable for one participant.
13.Secondary Outcome
Title Number of Participants With Serum Anti-drug Antibodies for Brazikumab
Hide Description [Not Specified]
Time Frame Predose at Weeks 0, 4, 12, 16, 28, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period. Number analyzed is number of participants with evaluable data at given time-point.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
Week 0 Number Analyzed 4 participants 5 participants 9 participants 7 participants 3 participants
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 4 Number Analyzed 4 participants 5 participants 8 participants 7 participants 3 participants
0
   0.0%
0
   0.0%
1
  12.5%
0
   0.0%
0
   0.0%
Week 12 Number Analyzed 4 participants 5 participants 9 participants 7 participants 3 participants
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 16 Number Analyzed 3 participants 5 participants 6 participants 4 participants 3 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 28 Number Analyzed 2 participants 2 participants 3 participants 3 participants 1 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 40 Number Analyzed 2 participants 1 participants 3 participants 2 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Week 52 Number Analyzed 0 participants 1 participants 3 participants 1 participants 0 participants
0
   0.0%
0
   0.0%
0
   0.0%
14.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs), TEAEs of Special Interest and TEAEs Leading to Discontinuation
Hide Description An AE is any untoward medical occurrence in a patient/clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with treatment. An adverse event can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of investigational product, whether or not related to the investigational product. A TEAE is any new AE or worsening of an existing condition after initiation of treatment. An SAE is an AE that resulted in death, inpatient hospitalization/prolongation of existing hospitalization, persistent or significant disability or incapacity, life threatening, a congenital anomaly/birth defect, or an important medical event. AE of special interest were infusion/injection-site reactions, hypersensitivity reactions, malignancies, cardiac events like myocardial infarction, stroke/cardiovascular death, ocular AE including cataracts.
Time Frame From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 5 5 9 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
5
 100.0%
4
  80.0%
8
  88.9%
7
 100.0%
2
  66.7%
TESAEs
0
   0.0%
1
  20.0%
0
   0.0%
2
  28.6%
1
  33.3%
TEAEs of Special Interest
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
  33.3%
TEAEs Leading to Discontinuation
1
  20.0%
0
   0.0%
0
   0.0%
1
  14.3%
0
   0.0%
15.Secondary Outcome
Title Number of Participants With Clinically Significant Laboratory Values
Hide Description Laboratory parameters included tests for hematology, serum chemistry and urinalysis. Laboratory values that were outside the reference range, considered clinically significant were reported.
Time Frame From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants who received at least 1 dose of investigational product.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 5 5 9 7 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
16.Secondary Outcome
Title Percentage of Participants With Abdominal Pain Response
Hide Description Abdominal pain response is defined as a ≥ 30% reduction in weekly pain score from baseline on an 11-point (0 to 10) pain scale, where 0 = no pain and 10 = worst imaginable pain.
Time Frame Baseline; Weeks 8, 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period. Participant with missing data for this outcome measure was imputed as a non-responder.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 50.0 40.0 44.4 28.6 66.7
Week 16 50.0 60.0 66.7 28.6 100.0
Week 28 50.0 0.0 33.3 0.0 33.3
17.Secondary Outcome
Title Percentage of Participants With Abdominal Pain Remission
Hide Description Abdominal pain remission is defined as no daily score > 2 on an 11-point (0 to 10) pain scale during 1 week, where 0 = no pain and 10 = worst imaginable pain.
Time Frame Weeks 8, 16 and 28
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized into the study and received at least 1 whole dose of investigational product for the 28-week, double-blind, placebo-controlled treatment period. Participant with missing data for this outcome measure was imputed as a non-responder.
Arm/Group Title Placebo Brazikumab High Dose Brazikumab High-Medium Dose Brazikumab Low-Medium Dose Brazikumab Low Dose
Hide Arm/Group Description:
Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 48 in the open-label period.
Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 210 mg, SC injection in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks in the maintenance phase and open-label period up to Week 48.
Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Participants received brazikumab 210 mg, SC injection, every 4 weeks up to Week 48 in the open-label period.
Overall Number of Participants Analyzed 4 5 9 7 3
Measure Type: Number
Unit of Measure: percentage of participants
Week 8 0.0 20.0 11.1 0.0 0.0
Week 16 0.0 40.0 0.0 0.0 0.0
Week 28 25.0 0.0 11.1 0.0 0.0
Time Frame From first dose of study drug up to 28 weeks post last dose (approximately up to Week 80)
Adverse Event Reporting Description Safety population included all participants who received at least 1 dose of investigational product.
 
Arm/Group Title DB: Placebo DB: Brazikumab High Dose DB: Brazikumab High-Medium Dose DB: Brazikumab Low-Medium Dose DB: Brazikumab Low Dose OL: Placebo/Brazikumab 210 mg OL: Brazikumab High Dose/Brazikumab 210 mg OL: Brazikumab High-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low Dose/Brazikumab 210 mg
Hide Arm/Group Description Placebo-matching brazikumab intravenous (IV) infusion and subcutaneous (SC) injection at Weeks 0 and 4 followed by placebo-matching brazikumab SC injection at Weeks 8 and 12 in the induction phase and at Weeks 16, 20 and 24 in the maintenance phase. Brazikumab 700 mg, IV infusion and placebo-matching brazikumab, SC injection at Weeks 0 and 4 followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks at Weeks 8 and 12 in the induction phase and Weeks 16, 20 and 24 in the maintenance phase. Brazikumab 280 mg, IV infusion and placebo-matching brazikumab, SC injection at Week 0 followed by brazikumab 210 mg, SC injection and placebo-matching brazikumab IV infusion at Week 4, followed by brazikumab 210 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 210 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Brazikumab 210 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 105 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 105 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 105 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Brazikumab 70 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 0 followed by brazikumab 35 mg, SC injection and placebo-matching brazikumab, IV infusion at Week 4, followed by brazikumab 35 mg, SC injection at Weeks 8 and 12 in the induction phase. Participants received brazikumab 35 mg, SC injection every 4 weeks up to Week 24 in the maintenance phase. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received placebo-matching brazikumab in the double-blind treatment period. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high dose of brazikumab in the double-blind treatment period. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received high-medium dose of brazikumab in the double-blind treatment period. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low-medium dose of brazikumab in the double-blind treatment period. Brazikumab 210 mg, SC injection every 4 weeks in the open-label period starting at Week 28 up to Week 48. Participants received low dose of brazikumab in the double-blind treatment period.
All-Cause Mortality
DB: Placebo DB: Brazikumab High Dose DB: Brazikumab High-Medium Dose DB: Brazikumab Low-Medium Dose DB: Brazikumab Low Dose OL: Placebo/Brazikumab 210 mg OL: Brazikumab High Dose/Brazikumab 210 mg OL: Brazikumab High-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low Dose/Brazikumab 210 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/9 (0.00%)   0/7 (0.00%)   0/3 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
DB: Placebo DB: Brazikumab High Dose DB: Brazikumab High-Medium Dose DB: Brazikumab Low-Medium Dose DB: Brazikumab Low Dose OL: Placebo/Brazikumab 210 mg OL: Brazikumab High Dose/Brazikumab 210 mg OL: Brazikumab High-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low Dose/Brazikumab 210 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   1/5 (20.00%)   0/9 (0.00%)   1/7 (14.29%)   1/3 (33.33%)   0/2 (0.00%)   0/3 (0.00%)   0/2 (0.00%)   1/3 (33.33%)   0/1 (0.00%) 
Gastrointestinal disorders                     
Crohn's disease † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Infections and infestations                     
Pneumonia † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Nervous system disorders                     
Ischaemic stroke † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Asthma † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DB: Placebo DB: Brazikumab High Dose DB: Brazikumab High-Medium Dose DB: Brazikumab Low-Medium Dose DB: Brazikumab Low Dose OL: Placebo/Brazikumab 210 mg OL: Brazikumab High Dose/Brazikumab 210 mg OL: Brazikumab High-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low-Medium Dose/Brazikumab 210 mg OL: Brazikumab Low Dose/Brazikumab 210 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/5 (100.00%)   4/5 (80.00%)   8/9 (88.89%)   7/7 (100.00%)   1/3 (33.33%)   2/2 (100.00%)   1/3 (33.33%)   1/2 (50.00%)   1/3 (33.33%)   0/1 (0.00%) 
Blood and lymphatic system disorders                     
Anaemia † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Cardiac disorders                     
Palpitations † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Ear and labyrinth disorders                     
Tinnitus † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Eye disorders                     
Cataract † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Conjunctivitis allergic † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Vision blurred † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Iritis † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Gastrointestinal disorders                     
Abdominal pain lower † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Crohn's disease † 1  1/5 (20.00%)  0/5 (0.00%)  1/9 (11.11%)  2/7 (28.57%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Gastritis † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Defaecation urgency † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Haemorrhoids † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Nausea † 1  1/5 (20.00%)  0/5 (0.00%)  1/9 (11.11%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Abdominal discomfort † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Anal fissure † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Constipation † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
General disorders                     
Asthenia † 1  1/5 (20.00%)  0/5 (0.00%)  1/9 (11.11%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Fatigue † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Feeling hot † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Non-cardiac chest pain † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Peripheral swelling † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Drug intolerance † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Infections and infestations                     
Folliculitis † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Herpes simplex † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Herpes zoster † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Lower respiratory tract infection † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Nasopharyngitis † 1  0/5 (0.00%)  2/5 (40.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Oral candidiasis † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Oral fungal infection † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Viral infection † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Skin candida † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Subcutaneous abscess † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Vulvovaginal mycotic infection † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Urinary tract infection † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Upper respiratory tract infection † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Postoperative abscess † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Enterobiasis † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/1 (0.00%) 
Gastroenteritis † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications                     
Contusion † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Spinal compression fracture † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Procedural nausea † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Investigations                     
Blood alkaline phosphatase increased † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Vitamin D decreased † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
White blood cell count increased † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Metabolism and nutrition disorders                     
Hypokalaemia † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Iron deficiency † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders                     
Arthralgia † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Back pain † 1  1/5 (20.00%)  1/5 (20.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Arthritis † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Joint swelling † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Eye naevus † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Melanocytic naevus † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Nervous system disorders                     
Headache † 1  1/5 (20.00%)  1/5 (20.00%)  1/9 (11.11%)  1/7 (14.29%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Paraesthesia † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Hypoaesthesia † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Psychiatric disorders                     
Depression † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Stress † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Renal and urinary disorders                     
Pollakiuria † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders                     
Cough † 1  0/5 (0.00%)  1/5 (20.00%)  1/9 (11.11%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Respiratory symptom † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Oropharyngeal pain † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Upper respiratory tract congestion † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders                     
Alopecia † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Eczema † 1  0/5 (0.00%)  1/5 (20.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Erythema † 1  0/5 (0.00%)  0/5 (0.00%)  1/9 (11.11%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Pruritus † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
Rash † 1  0/5 (0.00%)  0/5 (0.00%)  0/9 (0.00%)  1/7 (14.29%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  0/1 (0.00%) 
Vascular disorders                     
Phlebitis superficial † 1  1/5 (20.00%)  0/5 (0.00%)  0/9 (0.00%)  0/7 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
†
Indicates events were collected by systematic assessment
Due to small number of participants,29 randomized by study termination, only descriptive statistics for limited efficacy endpoints were provided. Enrollment did not achieve target power and was insufficient to produce statistically reliable results.
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.
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area, Head
Organization: Allergan
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02574637    
Other Study ID Numbers: D5170C00002
2015-000609-38 ( EudraCT Number )
First Submitted: September 24, 2015
First Posted: October 14, 2015
Results First Submitted: May 1, 2020
Results First Posted: May 15, 2020
Last Update Posted: May 15, 2020