A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of rhuMAb Beta7 in Patients With Ulcerative Colitis

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized , double-blind, placebo-controlled study of approximately 70 patients with ulcerative colitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.
• Treatments: Etrolizumab

Criteria

Inclusion Criteria:

• Able and willing to provide written informed consent

• 18-70 years of age

• Males and females with reproductive potential: Willing to use a reliable method of contraception

• Diagnosis of ulcerative colitis

• Eligible to receive biologic therapy

• Disease duration of >=12 weeks

Exclusion Criteria:

• Requirement for hospitalization due to severity of ulcerative colitis

• Moderate to severe anemia

• Any manifestation of ulcerative colitis or other conditions likely to require, in the investigator's judgment, treatment with >20 mg/day of prednisone, or prednisone equivalent, during the course of the study

• Pregnant or lactating

• Lack of peripheral venous access

• Inability to comply with study protocol

• History or presence of contraindicated diseases

• Congenital immune deficiency

• Active or prior infection with HIV or hepatitis B or C

• History of severe systemic bacterial, fungal, viral, or parasitic infections

• History of any other opportunistic infections within 12 weeks prior to initiation of study treatment

• Received a live attenuated vaccine within 4 weeks prior to screening

• Hospitalized within 4 weeks prior to screening

• Received any contraindicated therapy within 12 weeks prior to screening