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

Genentech

Status and phase

Completed

Phase 1

Conditions

Ulcerative Colitis

Treatments

Drug: rhuMAb Beta7

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

GA00930 (Other Identifier)

ABS4262g

Details and patient eligibility

About

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

Enrollment

48 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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