Basiliximab in Moderate to Severe Ulcerative Colitis

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00430898
• Other study ID #: BSX-001
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2007
• Last updated: December 17, 2008
• Start date: January 2007
• Est. completion date: September 2008

Study information

• Verified date: December 2008
• Source: Cerimon Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Basiliximab
3 doses of 40mg, IV at baseline, week 2, and week 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cerimon Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Czech Republic,  India,  Poland,  Russian Federation,  Slovakia,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mayo Score, Safety		At week 8	Yes
Secondary	Clinical remission at week 4; clinical response at weeks 4 and 8; use of rescue medication; hospitalization or colectomy; and concomitant steroid use		at week 4 and 8	Yes