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



Status:Completed
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:8/3/2016
Start Date:September 2008
End Date:September 2012

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A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous rhuMAb Beta7 Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Ulcerative Colitis

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


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
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