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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 2

Conditions

Crohn's Disease

Treatments

Drug: Placebo

Drug: BMS-936557 (Anti-IP-10 Antibody)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01466374

IM129-008

2011-002981-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

Anti-IP10: Anti Interferon-inducible ligand 10

Enrollment

121 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

121 participants in 7 patient groups

Cohort 1: Induction

Experimental group

Description:

Placebo

Treatment:

Drug: Placebo

Cohort 2: Induction

Experimental group

Description:

Anti-IP-10 Antibody

Treatment:

Drug: BMS-936557 (Anti-IP-10 Antibody)

Cohort 3: Induction

Experimental group

Description:

Anti-IP-10 Antibody

Treatment:

Drug: BMS-936557 (Anti-IP-10 Antibody)

Cohort 1: Maintenance

Experimental group

Description:

Placebo

Treatment:

Drug: Placebo

Cohort 2: Maintenance

Experimental group

Description:

Anti-IP-10 Antibody

Treatment:

Drug: BMS-936557 (Anti-IP-10 Antibody)

Cohort 3: Maintenance

Experimental group

Description:

Anti-IP-10 Antibody

Treatment:

Drug: BMS-936557 (Anti-IP-10 Antibody)

Cohort 1: Open Label

Experimental group

Description:

Anti-IP-10 Antibody

Treatment:

Drug: BMS-936557 (Anti-IP-10 Antibody)

Trial contacts and locations

33

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