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Basiliximab in Moderate to Severe Ulcerative Colitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00430898
Recruitment Status : Completed
First Posted : February 2, 2007
Last Update Posted : December 18, 2008
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Basiliximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of Basiliximab, With Concomitant Corticosteroids, in Steroid-Refractory Ulcerative Colitis
Study Start Date : January 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Basiliximab

Arm Intervention/treatment
Placebo Comparator: 1. Placebo
Placebo to mimic 40 mg of Simulect
Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Name: Simulect

Experimental: 2. 40 mg Simulect
40 mg of Simulect
Drug: Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4
Other Name: Simulect

Primary Outcome Measures :
  1. Change in Mayo Score, Safety [ Time Frame: At week 8 ]

Secondary Outcome Measures :
  1. Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use [ Time Frame: at week 4 and 8 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00430898

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Sponsors and Collaborators
Cerimon Pharmaceuticals
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Study Director: Daniel Levitt, MD, PhD Cerimon Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cerimon Pharmaceuticals, Inc, Cerimon Pharmaceuticals, Inc. Identifier: NCT00430898    
Other Study ID Numbers: BSX-001
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: December 18, 2008
Last Verified: December 2008
Keywords provided by Cerimon Pharmaceuticals:
ulcerative colitis basiliximab
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs