Basiliximab in Moderate to Severe Ulcerative Colitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00430898

Enrollment

181

Registered

2007-02-02

Start date

2007-01-31

Completion date

2008-09-30

Last updated

2008-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

ulcerative colitis basiliximab

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.

Interventions

DRUGBasiliximab

3 doses of 40mg, IV at baseline, week 2, and week 4

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Mayo Score, Safety	At week 8

Secondary

Measure	Time frame
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

Countries

Belgium, Czechia, India, Poland, Russia, Slovakia, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026