Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease
A Phase IIa, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Crohn's Disease
2 other identifiers
interventional
121
8 countries
33
Brief Summary
The purpose of this study is to determine whether BMS-936557 is effective for the treatment of moderate to severely active Crohn's Disease in patients who have had insufficient response and/or intolerance to conventional therapy for Crohn's Disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2011
Typical duration for phase_2
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 12, 2015
September 1, 2015
2.5 years
November 3, 2011
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical remission (CDAI score of <150)
CDAI: Crohn's Disease Activity Index
Week 11
Secondary Outcomes (4)
Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)
Week 7 and Week 11
Proportion of subjects in clinical response (defined as CDAI score reduction from Baseline of ≥ 100 points or an absolute CDAI score of < 150)
Week 7 and Week 11
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Week 11
Safety of BMS-936557 in the induction period defined by proportion of subjects reporting AE, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values
Week 11
Study Arms (7)
Cohort 1: Induction
EXPERIMENTALPlacebo
Cohort 2: Induction
EXPERIMENTALAnti-IP-10 Antibody
Cohort 3: Induction
EXPERIMENTALAnti-IP-10 Antibody
Cohort 1: Maintenance
EXPERIMENTALPlacebo
Cohort 2: Maintenance
EXPERIMENTALAnti-IP-10 Antibody
Cohort 3: Maintenance
EXPERIMENTALAnti-IP-10 Antibody
Cohort 1: Open Label
EXPERIMENTALAnti-IP-10 Antibody
Interventions
Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
Eligibility Criteria
You may qualify if:
- Adults subjects with confirmed Crohn's Disease (CD) for at least 3 months
- Moderate to severely active CD as defined by Crohn's Disease Activity Index (CDAI) 220 to 450
- In the past have had insufficient response and or intolerance to ≥ 1 of the conventional therapy (immunosuppressants, corticosteroids and/or approved biologic therapy)
You may not qualify if:
- Ulcerative colitis (UC) or indeterminate colitis
- Short bowel syndrome
- Known stricture or noninflammatory stenosis leading to symptoms of obstruction
- Current stoma or current need for colostomy or ileostomy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Southern California Medical Gastroenterology Group
Santa Monica, California, 90404, United States
Shafran Gasteroenterology Center
Winter Park, Florida, 32789, United States
Gastroenterology Research Of New Orleans
Hammond, Louisiana, 70403, United States
Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
Chevy Chase, Maryland, 20815, United States
Midwest Center For Clinical Research
Lees Summit, Missouri, 64064, United States
Nyu Langone Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
Mount Sinai School Of Medicine
New York, New York, 10029, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Consultants For Clinical Research
Cincinnati, Ohio, 45219, United States
Gastroenterology Research Of San Antonio
San Antonio, Texas, 78229, United States
Local Institution
Brussels, 1090, Belgium
Local Institution
Leuven, 3000, Belgium
Local Institution
Amiens, 80054, France
Local Institution
Clichy, 92110, France
Local Institution
Nice, 06200, France
Local Institution
Pessac, 33064, France
Local Institution
Rouen, 76031, France
Local Institution
Vandœuvre-lès-Nancy, 54511, France
Local Institution
Budapest, 1083, Hungary
Local Institution
Budapest, 1088, Hungary
Local Institution
Budapest, H-1115, Hungary
Local Institution
Debrecen, 4012, Hungary
Local Institution
Haifa, 31048, Israel
Local Institution
Kfar Saba, 44281, Israel
Local Institution
Nazareth, 16100, Israel
Local Institution
Krakow, 31-501, Poland
Local Institution
Rzeszów, 35-068, Poland
Local Institution
Warsaw, 02-507, Poland
Local Institution
Warsaw, 03-580, Poland
University Of Puerto Rico School Of Medicine
San Juan, 00936, Puerto Rico
Local Institution
Overport, KwaZulu-Natal, 4091, South Africa
Local Institution
Claremont, Western Cape, 7708, South Africa
Local Institution
Panorama, Western Cape, 7506, South Africa
Related Publications (2)
Sandborn WJ, Rutgeerts P, Colombel JF, Ghosh S, Petryka R, Sands BE, Mitra P, Luo A. Eldelumab [anti-interferon-gamma-inducible protein-10 antibody] Induction Therapy for Active Crohn's Disease: a Randomised, Double-blind, Placebo-controlled Phase IIa Study. J Crohns Colitis. 2017 Jul 1;11(7):811-819. doi: 10.1093/ecco-jcc/jjx005.
PMID: 28333187DERIVEDKhanna R, Zou G, D'Haens G, Rutgeerts P, McDonald JW, Daperno M, Feagan BG, Sandborn WJ, Dubcenco E, Stitt L, Vandervoort MK, Donner A, Luo A, Levesque BG. Reliability among central readers in the evaluation of endoscopic findings from patients with Crohn's disease. Gut. 2016 Jul;65(7):1119-25. doi: 10.1136/gutjnl-2014-308973. Epub 2015 May 2.
PMID: 25935574DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2011
First Posted
November 8, 2011
Study Start
December 1, 2011
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
October 12, 2015
Record last verified: 2015-09