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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01466374
First Posted: November 8, 2011
Last Update Posted: October 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    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 ]
  • 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 ]
  • Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: 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


Enrollment: 121
Study Start Date: December 2011
Study Completion Date: December 2014
Primary Completion Date: June 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01466374


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01466374     History of Changes
Other Study ID Numbers: IM129-008
2011-002981-19 ( EudraCT Number )
First Submitted: November 3, 2011
First Posted: November 8, 2011
Last Update Posted: October 12, 2015
Last Verified: September 2015

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