Basiliximab in Moderate to Severe Ulcerative Colitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Basiliximab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In addition to others, Men or women age 18-75 Diagnosis of ulcerative colitis confirmed through screening endoscopy. Extent of disease must involve at least the left colon Moderate to severe disease (Mayo Score 6-12). Systemic features of tachycardia, fever, and/or significant anemia should not be present. Inadequate response despite treatment with prednisone 40 - 50 mg/day (or other oral steroid at equivalent dose) orally for a minimum of 14 days immediately preceding study entry Exclusion Criteria: In addition to other protocol-defined conditions, Pregnancy Stool study that shows presence of ova and parasites, significant bacterial pathogens, or C. difficile toxin Colitis that is indeterminate, suggestive of Crohn's disease, or isolated to the rectum, based on endoscopic and/or biopsy findings Severely ill patients as evidenced by protocol-defined systemic criteria Chest radiograph abnormalities consistent with an infectious process History of colonic dysplasia HIV infection Known viral Hepatitis B or C infection History of or exposure to tuberculosis within 6 months before study entry

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Placebo Comparator: 1. Placebo<br>Placebo to mimic 40 mg of Simulect | Drug: Basiliximab<br>* 3 doses of 40mg, IV at baseline, week 2, and week 4<br>* Other names: Simulect;|
| Experimental: 2. 40 mg Simulect<br>40 mg of Simulect | Drug: Basiliximab<br>* 3 doses of 40mg, IV at baseline, week 2, and week 4<br>* Other names: Simulect;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mayo Score, Safety |  | At week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use |  | at week 4 and 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ulcerative colitis basiliximab