Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

Phase 2

Completed

• Conditions: Colitis, Ulcerative
• Interventions: Drug: Placebo; Drug: Anti-IP-10 Antibody

• Registration Number: NCT01294410
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Study Start: 2011-03
• Primary Completion: 2012-12
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

Inclusion Criteria

• Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
• Mayo score ≥6 with an endoscopic subscore of ≥2
• Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

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Exclusion Criteria

• Diagnosis of Crohn's Disease or Indeterminate Colitis
• Diagnosis of UC that is limited to the rectum
• Evidence of fulminant colitis, toxic megacolon, or bowel perforation
• Current need for a colostomy or ileostomy
• Previous total or subtotal colectomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Induction	Anti-IP-10 Antibody	Placebo or Anti-IP-10 Antibody
Open Label	Anti-IP-10 Antibody	-
Cohort 1: Induction	Placebo	Placebo or Anti-IP-10 Antibody
Maintenance	Placebo	Placebo or Anti-IP-10 Antibody
Cohort 2: Induction	Anti-IP-10 Antibody	Placebo or Anti-IP-10 Antibody
Cohort 3: Induction	Anti-IP-10 Antibody	Placebo or Anti-IP-10 Antibody
Cohort 2: Induction	Placebo	Placebo or Anti-IP-10 Antibody
Cohort 3: Induction	Placebo	Placebo or Anti-IP-10 Antibody
Maintenance	Anti-IP-10 Antibody	Placebo or Anti-IP-10 Antibody

Primary Outcome Measures

Name	Time	Method
Proportion of the subjects with clinical remission (defined as Mayo score ≤ 2 points with no individual subscore > 1 point) of BMS-936557 with that of the placebo	End of Induction [Week 11, Induction Period-78 (IP-78)]

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with mucosal healing (defined as endoscopy subscore of ≤1 point) of BMS-936557 with that of the placebo	IP-78 (Week 11)
Mean change from baseline at Inflammatory Bowel Disease Questionnaire (IBDQ) of subjects treated with BMS-936557 and placebo	Baseline (IP-1, Week 1) and IP-78 (Week 11)
Proportion of the subjects with clinical response of BMS-936557 with that of the placebo	IP-78 (Week 11)	Defined as a reduction from baseline in Mayo score ≥3 points and ≥30% and decrease from baseline in rectal bleeding subscore ≥1 point or absolute rectal bleeding subscore ≤1 point
Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values	IP-78 (Week 11)

Trial Locations

Locations (24)

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

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

Minnesota Gastroenterology, Pa; 🇺🇸 Plymouth, Minnesota, United States

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

Westglen Gastrointestinal Consultants; 🇺🇸 Lee's Summit, Missouri, United States

Gastroenterology Research Of Lima; 🇺🇸 Lima, Ohio, United States

Pharma Resource; 🇺🇸 East Providence, Rhode Island, United States

University Of California, San Diego; 🇺🇸 La Jolla, California, United States

Western States Clinical Research Inc.; 🇺🇸 Wheatridge, Colorado, United States

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

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

Charlotte Gastroenterology & Hepatology, Pllc; 🇺🇸 Charlotte, North Carolina, United States

Local Institution; 🇿🇦 Paarl, South Africa

Gastroenterology Research Of Tyler (Gerty); 🇺🇸 Tyler, Texas, United States

University Of Florida; 🇺🇸 Gainesville, Florida, United States

Health Science Research Center; 🇺🇸 Pratt, Kansas, United States

Santa Monica Research Institute; 🇺🇸 Santa Monica, California, United States

University Of Kentucky; 🇺🇸 Lexington, Kentucky, United States

Long Island Clinical Research Assoc., Llp; 🇺🇸 Great Neck, 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

Nashville Medical Research Institute; 🇺🇸 Nashville, Tennessee, United States

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

University Of Louisville; 🇺🇸 Louisville, Kentucky, United States