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

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: placebo; Drug: rhuMAb Beta7

• Registration Number: NCT00694980
• Lead Sponsor: Genentech, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-06-07
• Study First Submitted QC: 2008-06-07
• Study First Posted: 2008-06-11
• Study Start: 2008-09
• Primary Completion: 2011-09
• Study Completion: 2012-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
1	rhuMAb Beta7	-

Primary Outcome Measures

Name	Time	Method
Incidence, nature, and severity of adverse events	Through study completion or early study discontinuation
Incidence and nature of laboratory abnormalities	Through study completion or early study discontinuation

Secondary Outcome Measures

Name	Time	Method
Incidence of antibodies directed against rhuMAb Beta7	Through study completion or early study discontinuation
PK profile and parameters	Through study completion or early study discontinuation