Basiliximab in Moderate to Severe Ulcerative Colitis

Cerimon Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Ulcerative Colitis

Treatments

Drug: Basiliximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00430898

BSX-001

Details and patient eligibility

About

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.

Enrollment

181 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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