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 |
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.
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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