Basiliximab in Moderate to Severe Ulcerative Colitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00430898

Run by

Cerimon Pharmaceuticals

People needed

181

Starts

2007-01-01

Expected to finish

2008-09-01

Last updated by the study team

2008-12-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Roseville, California, United States
• Study site — Golden, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Hollywood, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Winter Park, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Urbana, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Topeka, Kansas, United States
• Study site — Lexington, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Troy, Michigan, United States
• Study site — Egg Harbor Twp, New Jersey, United States
• Study site — Great Neck, New York, United States
• Study site — New York, New York, United States
• Study site — Fargo, North Dakota, United States
• Study site — Cleveland, Ohio, United States
• Study site — Sewickley, Pennsylvania, United States
• Study site — Germantown, Tennessee, United States
• Study site — Fort Worth, Texas, United States
• Study site — Galveston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Anaheim, California, United States

Full record on ClinicalTrials.gov

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