A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Visilizumab in Subjects With Intravenous Steroid-Refractory Ulcerative Colitis

Facet Biotech

Status and phase: Withdrawn; Phase 3

Conditions: Intravenous Steroid-Refractory Ulcerative Colitis

Treatments: Drug: Visilizumab (HuM291; Nuvion®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00502294

291-416

Details and patient eligibility

About

To compare the efficacy of visilizumab at 5 mcg/kg/day administered intravenously (IV) on Days 1 and 2 to placebo in subjects with IVSR-UC.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Males and females, 18 years of age or older.
• Diagnosis of UC verified by endoscopy within 60 months prior to consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind