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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01466374
• Other study ID #: IM129-008
• Secondary ID: 2011-002981-19
• Status: Completed
• Phase: Phase 2
• First received: November 3, 2011
• Last updated: September 23, 2015
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Anti-IP10: Anti Interferon-inducible ligand 10

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Placebo
Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
• Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
• BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
• BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
• BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
• BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
• BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open

Locations

Country	Name	City	State
Belgium	Local Institution	Brussel
Belgium	Local Institution	Leuven
France	Local Institution	Amiens Cedex 1
France	Local Institution	Clichy
France	Local Institution	Nice
France	Local Institution	Pessac
France	Local Institution	Rouen
France	Local Institution	Vandoeuvre Les Nancy
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Budapest
Hungary	Local Institution	Debrecen
Israel	Local Institution	Haifa
Israel	Local Institution	Kfar Saba
Israel	Local Institution	Nazareth
Poland	Local Institution	Krakow
Poland	Local Institution	Rzeszow
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
Puerto Rico	University Of Puerto Rico School Of Medicine	San Juan
South Africa	Local Institution	Claremont	Western Cape
South Africa	Local Institution	Overport	Kwa Zulu Natal
South Africa	Local Institution	Panorama	Western Cape
United States	University Of North Carolina At Chapel Hill	Chapel Hill	North Carolina
United States	Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr	Chevy Chase	Maryland
United States	Consultants For Clinical Research	Cincinnati	Ohio
United States	Nyu Langone Long Island Clinical Research Associates	Great Neck	New York
United States	Gastroenterology Research Of New Orleans	Hammond	Louisiana
United States	Midwest Center For Clinical Research	Lees Summit	Missouri
United States	Mount Sinai School Of Medicine	New York	New York
United States	Gastroenterology Research Of San Antonio	San Antonio	Texas
United States	Southern California Medical Gastroenterology Group	Santa Monica	California
United States	Shafran Gasteroenterology Center	Winter Park	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium,  France,  Hungary,  Israel,  Poland,  Puerto Rico,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission (CDAI score of <150)	CDAI: Crohn's Disease Activity Index	Week 11	No
Secondary	Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)		Week 7 and Week 11	No
Secondary	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	No
Secondary	Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)		Week 11	No
Secondary	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	AE - Adverse Event SAE - Serious Adverse Event	Week 11	Yes

External Links

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