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

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

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: placebo
* Drug: rhuMAb Beta7


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: placebo<br>* Intravenous and subcutaneous escalating doses<br>Drug: rhuMAb Beta7<br>* Intravenous and subcutaneous escalating doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and nature of laboratory abnormalities |  | Through study completion or early study discontinuation | 
| Incidence, nature, and severity of adverse events |  | Through study completion or early study discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile and parameters |  | Through study completion or early study discontinuation | 
| Incidence of antibodies directed against rhuMAb Beta7 |  | Through study completion or early study discontinuation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UC, Ulcerative Colitis