Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Colitis, Ulcerative

Treatments: Drug: Anti-IP-10 Antibody; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294410

IM129-005

2010-022506-41 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical therapy for ulcerative colitis

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of moderate to severe UC confirmed by endoscopic and histologic evidence
• Mayo score ≥6 with an endoscopic subscore of ≥2
• Inadequate response and/or intolerance to one or more conventional therapy (i.e. oral aminosalicylates, immunosuppressants, corticosteroids, and/or TNF antagonist)

Exclusion criteria

• Diagnosis of Crohn's Disease or Indeterminate Colitis
• Diagnosis of UC that is limited to the rectum
• Evidence of fulminant colitis, toxic megacolon, or bowel perforation
• Current need for a colostomy or ileostomy
• Previous total or subtotal colectomy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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305 participants in 5 patient groups

Cohort 1: Induction

Experimental group

Description:

Placebo or Anti-IP-10 Antibody

Treatment:

Drug: Anti-IP-10 Antibody

Drug: Placebo

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Placebo

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Cohort 2: Induction

Experimental group

Description:

Placebo or Anti-IP-10 Antibody

Treatment:

Drug: Anti-IP-10 Antibody

Drug: Placebo

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Placebo

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Cohort 3: Induction

Experimental group

Description:

Placebo or Anti-IP-10 Antibody

Treatment:

Drug: Anti-IP-10 Antibody

Drug: Placebo

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Placebo

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Maintenance

Experimental group

Description:

Placebo or Anti-IP-10 Antibody

Treatment:

Drug: Anti-IP-10 Antibody

Drug: Placebo

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Placebo

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Open Label

Other group

Treatment:

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody

Drug: Anti-IP-10 Antibody