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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01466374
First received: November 3, 2011
Last updated: July 9, 2014
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Crohn's Disease
Drug: Placebo
Drug: BMS-936557 (Anti-IP-10 Antibody)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Clinical remission (CDAI score of <150) [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
    CDAI: Crohn's Disease Activity Index


Secondary Outcome Measures:
  • Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150) [ Time Frame: Week 7 and Week 11 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Week 11 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
    AE - Adverse Event SAE - Serious Adverse Event


Estimated Enrollment: 130
Study Start Date: December 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 Name: Anti-IP-10 Antibody
Experimental: Cohort 3: Induction
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 Name: Anti-IP-10 Antibody
Experimental: Cohort 1: Maintenance
Placebo
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, 7.5 mg/kg, Every other week, Up to 337 days
Experimental: Cohort 3: Maintenance
Anti-IP-10 Antibody
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
Experimental: Cohort 1: Open Label
Anti-IP-10 Antibody
Drug: BMS-936557 (Anti-IP-10 Antibody)
Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open

Detailed Description:

Anti-IP10: Anti Interferon-inducible ligand 10

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01466374

  Show 33 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01466374     History of Changes
Other Study ID Numbers: IM129-008, 2011-002981-19
Study First Received: November 3, 2011
Last Updated: July 9, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014