Status:
COMPLETED
Basiliximab in Moderate to Severe Ulcerative Colitis
Lead Sponsor:
Cerimon Pharmaceuticals
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2008
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00430898
Start Date
January 1 2007
End Date
September 1 2008
Last Update
December 18 2008
Active Locations (68)
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1
Anaheim, California, United States
2
Roseville, California, United States, 95661
3
Golden, Colorado, United States
4
Littleton, Colorado, United States