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Completed

NCT Number: NCT00430898

Basiliximab in Moderate to Severe Ulcerative Colitis

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basiliximab

Drug

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

Other names: Simulect

Primary outcomes

  1. Change in Mayo Score, Safety

    Time frame: At week 8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Cerimon Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 2, 2007
Registry last updated
Dec 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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