Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
181 participants
INTERVENTIONAL
2007-01-31
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1. Placebo
Placebo to mimic 40 mg of Simulect
Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
2. 40 mg Simulect
40 mg of Simulect
Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Interventions
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Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Cerimon Pharmaceuticals
INDUSTRY
Responsible Party
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Cerimon Pharmaceuticals, Inc.
Principal Investigators
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Daniel Levitt, MD, PhD
Role: STUDY_DIRECTOR
Cerimon Pharmaceuticals
Locations
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Anaheim, California, United States
Roseville, California, United States
Golden, Colorado, United States
Littleton, Colorado, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Urbana, Illinois, United States
Indianapolis, Indiana, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Boston, Massachusetts, United States
Troy, Michigan, United States
Egg Harbor Twp, New Jersey, United States
Great Neck, New York, United States
New York, New York, United States
Fargo, North Dakota, United States
Cleveland, Ohio, United States
Sewickley, Pennsylvania, United States
Germantown, Tennessee, United States
Fort Worth, Texas, United States
Galveston, Texas, United States
Houston, Texas, United States
Leuven, , Belgium
Mladá Boleslav, , Czechia
Prague, , Czechia
Prague, , Czechia
Prague, , Czechia
Tábor, , Czechia
Ústí nad Orlicí, , Czechia
Bangalore, , India
Hyderabaad, , India
Kochi, , India
Kolkata, , India
Lucknow, , India
Ludhiana, , India
Mumbai, , India
New Delhi, , India
Visakhapatnam, , India
Gdansk, , Poland
Krakow, , Poland
Krakow, , Poland
Poznan, , Poland
Sopot, , Poland
Sopot, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Moscow, , Russia
Moscow, , Russia
Samara, , Russia
Smolensk, , Russia
Bratislava, , Slovakia
Bratislava, , Slovakia
Nitra, , Slovakia
Nové Mesto nad Váhom, , Slovakia
Prešov, , Slovakia
Dnipro, , Ukraine
Ivano-Frankivsk, , Ukraine
Kharkiv, , Ukraine
Kyiv, , Ukraine
Kyiv, , Ukraine
Bristol, , United Kingdom
Derbyshire, , United Kingdom
London, , United Kingdom
Stoke-on-Trent, , United Kingdom
Wigan, , United Kingdom
Countries
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References
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Sands BE, Sandborn WJ, Creed TJ, Dayan CM, Dhanda AD, Van Assche GA, Gregus M, Sood A, Choudhuri G, Stempien MJ, Levitt D, Probert CS. Basiliximab does not increase efficacy of corticosteroids in patients with steroid-refractory ulcerative colitis. Gastroenterology. 2012 Aug;143(2):356-64.e1. doi: 10.1053/j.gastro.2012.04.043. Epub 2012 Apr 28.
Other Identifiers
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BSX-001
Identifier Type: -
Identifier Source: org_study_id