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Completed

NCT Number: NCT01466374

Induction and Maintenance Study of BMS-936557 in Patients With Moderate to Severely 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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution, Brussels, Belgium

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About this study

Anti-IP10: Anti Interferon-inducible ligand 10

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks

BMS-936557 (Anti-IP-10 Antibody)

Drug

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

Primary outcomes

  1. Clinical remission (CDAI score of <150)

    Time frame: Week 11

    CDAI: Crohn's Disease Activity Index

Secondary outcomes

  1. Proportion of subjects in clinical remission (defined by an absolute CDAI score < 150)

    Time frame: Week 7 and Week 11

  2. 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

  3. Mean change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: Week 11

  4. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2011
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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