Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely Active Crohn's Disease

Phase 2

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: Placebo; Drug: BMS-936557 (Anti-IP-10 Antibody)

• Registration Number: NCT01466374
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Anti-IP10: Anti Interferon-inducible ligand 10

Study Timeline

• Study First Submitted: 2011-11-03
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-08
• Study Start: 2011-12
• Primary Completion: 2014-06
• Study Completion: 2014-12
• Status Verified: 2015-09
• Disposition First Submitted: 2015-09-23
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Induction	Placebo	Placebo
Cohort 2: Induction	BMS-936557 (Anti-IP-10 Antibody)	Anti-IP-10 Antibody
Cohort 2: Maintenance	BMS-936557 (Anti-IP-10 Antibody)	Anti-IP-10 Antibody
Cohort 1: Maintenance	Placebo	Placebo
Cohort 3: Induction	BMS-936557 (Anti-IP-10 Antibody)	Anti-IP-10 Antibody
Cohort 3: Maintenance	BMS-936557 (Anti-IP-10 Antibody)	Anti-IP-10 Antibody
Cohort 1: Open Label	BMS-936557 (Anti-IP-10 Antibody)	Anti-IP-10 Antibody

Primary Outcome Measures

Name	Time	Method
Clinical remission (CDAI score of <150)	Week 11	CDAI: Crohn's Disease Activity Index

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)	Week 7 and 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	AE - Adverse Event SAE - Serious Adverse Event
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

Trial Locations

Locations (12)

Southern California Medical Gastroenterology Group; 🇺🇸 Santa Monica, California, United States

Shafran Gasteroenterology Center; 🇺🇸 Winter Park, Florida, United States

Gastroenterology Research Of New Orleans; 🇺🇸 Hammond, Louisiana, United States

Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr; 🇺🇸 Chevy Chase, Maryland, United States

Midwest Center For Clinical Research; 🇺🇸 Lees Summit, Missouri, United States

Nyu Langone Long Island Clinical Research Associates; 🇺🇸 Great Neck, New York, United States

Mount Sinai School Of Medicine; 🇺🇸 New York, New York, United States

University Of North Carolina At Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Consultants For Clinical Research; 🇺🇸 Cincinnati, Ohio, United States

Gastroenterology Research Of San Antonio; 🇺🇸 San Antonio, Texas, United States

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