Basiliximab in Moderate to Severe Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: Basiliximab

• Registration Number: NCT00430898
• Lead Sponsor: Cerimon Pharmaceuticals

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-01-31
• Study First Submitted QC: 2007-01-31
• Study First Posted: 2007-02-02
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-17
• Last Update Posted: 2008-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2. 40 mg Simulect	Basiliximab	40 mg of Simulect
1. Placebo	Basiliximab	Placebo to mimic 40 mg of Simulect

Primary Outcome Measures

Name	Time	Method
Change in Mayo Score, Safety	At week 8

Secondary Outcome Measures

Name	Time	Method
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