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

September 23, 2015 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anti-IP10: Anti Interferon-inducible ligand 10

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussel, Belgium, 1090
        • Local Institution
      • Leuven, Belgium, 3000
        • Local Institution
  • France
      • Amiens Cedex 1, France, 80054
        • Local Institution
      • Clichy, France, 92110
        • Local Institution
      • Nice, France, 06200
        • Local Institution
      • Pessac, France, 33064
        • Local Institution
      • Rouen, France, 76031
        • Local Institution
      • Vandoeuvre Les Nancy, France, 54511
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1083
        • Local Institution
      • Budapest, Hungary, 1088
        • Local Institution
      • Budapest, Hungary, H-1115
        • Local Institution
      • Debrecen, Hungary, 4012
        • Local Institution
  • Israel
      • Haifa, Israel, 31048
        • Local Institution
      • Kfar Saba, Israel, 44281
        • Local Institution
      • Nazareth, Israel, 16100
        • Local Institution
  • Poland
      • Krakow, Poland, 31-501
        • Local Institution
      • Rzeszow, Poland, 35-068
        • Local Institution
      • Warszawa, Poland, 02-507
        • Local Institution
      • Warszawa, Poland, 03-580
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00936
        • University of Puerto Rico School of Medicine
  • South Africa
    • Kwa Zulu Natal
      • Overport, Kwa Zulu Natal, South Africa, 4091
        • Local Institution
    • Western Cape
      • Claremont, Western Cape, South Africa, 7708
        • Local Institution
      • Panorama, Western Cape, South Africa, 7506
        • Local Institution
  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Southern California Medical Gastroenterology Group
    • Florida
      • Winter Park, Florida, United States, 32789
        • Shafran Gasteroenterology Center
    • Louisiana
      • Hammond, Louisiana, United States, 70403
        • Gastroenterology Research Of New Orleans
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group, Pc, Chevy Chase Cr
    • Missouri
      • Lees Summit, Missouri, United States, 64064
        • Midwest Center For Clinical Research
    • New York
      • Great Neck, New York, United States, 11021
        • NYU Langone Long Island Clinical Research Associates
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
    • Texas
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Induction
Placebo
Drug: Placebo
Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
Drug: Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
Experimental: Cohort 2: Induction
Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
Experimental: Cohort 3: Induction
Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
Experimental: Cohort 1: Maintenance
Placebo
Drug: Placebo
Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
Drug: Placebo
Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
Experimental: Cohort 2: Maintenance
Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
Experimental: Cohort 3: Maintenance
Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
Experimental: Cohort 1: Open Label
Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: 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
Other Names:
  • Anti-IP-10 Antibody
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical remission (CDAI score of <150)
Time Frame: Week 11
CDAI: Crohn's Disease Activity Index
Week 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)
Time Frame: Week 7 and Week 11
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)
Time Frame: Week 7 and Week 11
Week 7 and Week 11
Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: Week 11
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
Time Frame: Week 11
AE - Adverse Event SAE - Serious Adverse Event
Week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 3, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM129-008
  • 2011-002981-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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