An Open Label Evaluation of the Safety and Efficacy of Basiliximab Maintenance in Ulcerative Colitis - BSX-002

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 135

Inclusion Criteria

Subjects must satisfy all of the following inclusion criteria to be eligible for the study:
1.Previously met eligibility criteria in the previous basiliximab UC study
2.Completed all study visits in previous study, even if they discontinued study drug dosing before the end of the study
3.Must have a total Mayo score at entry to BSX-002 consistent with clinical response or clinical remission as follows:
-Clinical remission is defined as a total Mayo score of 2 points or less, with no individual subscore exceeding 1 point.
-Clinical response is defined as a decrease in total Mayo score of at least 3 points, with a decrease in rectal bleeding subscore of at least 1 point and/or an absolute rectal bleeding subscore of 0 or 1.
4. Signed a current IRB/IEC-approved informed consent form
5.Females of childbearing potential must use an effective birth control method, and be willing to continue birth control during the study, and for 4 months after the last dose of study drug.
6.Females of non-childbearing potential should be surgically sterile (bilateral tubal ligation with surgery at least 6 months before study entry, hysterectomy, or bilateral oophorectomy at least 2 months before study entry) or post-menopausal for at least 2 years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Presence of any of the following conditions will exclude the subject from eligibility for the study:
1.Subject discontinued blinded study drug in previous study due to a study-drug related adverse event
2.Subject is severely ill, as evidenced by more than 6 episodes of loose stools, all of them bloody, during a 24-hour period within the prior 7 days, concurrent with any of the following systemic features:
-Heart rate > 90 beats/min at rest
-Temperature > 37.8 degrees C
-Hemoglobin < 10.5 g/dL
3. Subject is currently receiving a restricted/prohibited concomitant medication
4.Subject has undergone colectomy (total, or subtotal)
5. Subject has HIV infection
6.Subject is pregnant or breast-feeding
7.Prior noncompliance with previous study visit schedule and requirements

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary Objective<br>Assess the safety of 40 mg basiliximab given intravenously, at 4 week intervals, in ulcerative colitis. <br>;Secondary Objective: Secondary Objectives<br>Secondary objectives are to assess the efficacy and the immunogenicity of this multiple-dose regimen in this population.<br>;Primary end point(s): Safety of multiple doses administered monthly to maintain reduction in the signs and symptoms of ulcerative colitis

Secondary Outcome Measures

Name	Time	Method

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