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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01466374

Enrollment

121

Registered

2011-11-08

Start date

2011-12-31

Completion date

2014-12-31

Last updated

2015-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief 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.

Detailed description

Anti-IP10: Anti Interferon-inducible ligand 10

Interventions

DRUGPlacebo

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

DRUGBMS-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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026