Overview

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