Basiliximab in Moderate to Severe Ulcerative Colitis

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cerimon Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Basiliximab

Criteria

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