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

Colitis, Ulcerative Clinical Trial

Official title:

A Phase IIb Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy With BMS-936557 in Subjects With Active Ulcerative Colitis (UC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294410
• Other study ID #: IM129-005
• Secondary ID: 2010-022506-41
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2011
• Last updated: June 24, 2015
• Start date: March 2011
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationCanada: Health CanadaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: National Health and Medical Research CouncilMexico: Federal Commission for Sanitary Risks ProtectionBrazil: National Health Surveillance AgencyBrazil: National Committee of Ethics in ResearchSouth Africa: Medicines Control CouncilFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicinal Products and Health ProductsNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Austria: Federal Office for Safety in Health CareGermany: Paul-Ehrlich-InstitutHungary: National Institute of PharmacyPoland: National Institute of MedicinesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsItaly: Ministry of HealthItaly: Ethics CommitteeItaly: National Institute of HealthItaly: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer

Intervention

Drug:
• Placebo
Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
• Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
• Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
• Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
• Anti-IP-10 Antibody
Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
• Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
• Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
• Anti-IP-10 Antibody
Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open

Locations

Country	Name	City	State
Australia	Local Institution	Concord	New South Wales
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Garran	Australian Capital Territory
Australia	Local Institution	Herston	Queensland
Australia	Local Institution	Parkville	Victoria
Australia	Local Institution	South Brisbane	Victoria
Austria	Local Institution	Graz
Austria	Local Institution	Vienna
Belgium	Local Institution	Bonheiden
Belgium	Local Institution	Edegem
Belgium	Local Institution	Leuven
Brazil	Local Institution	Botucatu	Sao Paulo
Brazil	Local Institution	Goiania	Goias
Brazil	Local Institution	Rio De Janeiro
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Kingston	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Vaughan	Ontario
France	Local Institution	Clichy
France	Local Institution	Lille Cedex
France	Local Institution	Nice
France	Local Institution	Pessac
France	Local Institution	Vandoeuvre Les Nancy
Germany	Local Institution	Hamburg
Germany	Local Institution	Kiel
Germany	Local Institution	Muenster
Germany	Local Institution	Muenster
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Hungary	Local Institution	Szeged
Italy	Local Institution	Padova
Italy	Local Institution	Roma
Italy	Local Institution	San Donato Milanese (mi)
Italy	Local Institution	San Giovanni Rotondo (fg)
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Mexico, D. F.	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Veracruz
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Amsterdam
Netherlands	Local Institution	Rotterdam
Poland	Local Institution	Rzeszow
Poland	Local Institution	Sosnowiec
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
South Africa	Local Institution	Claremont	Western Cape
South Africa	Local Institution	Overport	Kwa Zulu Natal
South Africa	Local Institution	Paarl
South Africa	Local Institution	Panorama	Western Cape
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	University Of North Carolina At Chapel Hill	Chapel Hill	North Carolina
United States	Charlotte Gastroenterology & Hepatology, Pllc	Charlotte	North Carolina
United States	Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr	Chevy Chase	Maryland
United States	Consultants For Clinical Research	Cincinnati	Ohio
United States	Pharma Resource	East Providence	Rhode Island
United States	University Of Florida	Gainesville	Florida
United States	Long Island Clinical Research Assoc., Llp	Great Neck	New York
United States	Gastroenterology Research Of New Orleans	Hammond	Louisiana
United States	University Of California, San Diego	La Jolla	California
United States	Westglen Gastrointestinal Consultants	Lee's Summit	Missouri
United States	University Of Kentucky	Lexington	Kentucky
United States	Gastroenterology Research Of Lima	Lima	Ohio
United States	University Of Louisville	Louisville	Kentucky
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Mount Sinai School Of Medicine	New York	New York
United States	Minnesota Gastroenterology, Pa	Plymouth	Minnesota
United States	Health Science Research Center	Pratt	Kansas
United States	Gastroenterology Research Of San Antonio	San Antonio	Texas
United States	Santa Monica Research Institute	Santa Monica	California
United States	Gastroenterology Research Of Tyler (Gerty)	Tyler	Texas
United States	Western States Clinical Research Inc.	Wheatridge	Colorado
United States	Shafran Gasteroenterology Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Hungary,  Italy,  Mexico,  Netherlands,  Poland,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)]	No
Secondary	Proportion of the subjects with clinical response of BMS-936557 with that of the placebo	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	IP-78 (Week 11)	No
Secondary	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)	No
Secondary	Proportion of subjects reporting Adverse event (AE), Serious adverse events (SAEs), AEs leading to discontinuation, and markedly abnormal laboratory values		IP-78 (Week 11)	Yes
Secondary	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)	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form