Steroid-refractory ulcerative colitis MedDRA version: 8.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative
Conditions
Interventions
Trade Name: Simulect
Product Name: Basiliximab
Pharmaceutical Form: Powder for infusion*
Other descriptive name: Basiliximab
Concentrati
Sponsors
Cerimon Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 is pregnant or breast-feeding 6. Prior noncompliance with previous study visit schedule and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective Assess the safety of 40 mg basiliximab given intravenously, at 4 week intervals, in ulcerative colitis. ; Secondary Objective: Secondary Objectives Secondary objectives are to assess the efficacy and the immunogenicity of this multiple-dose regimen in this population. ;Primary end point(s): Safety of multiple doses administered monthly to maintain reduction in the signs and symptoms of ulcerative colitis | — |
Countries
Belgium, Czech Republic, Slovakia, United Kingdom
Outcome results
None listed