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

INTERVENTION:

Trade Name: Simulect Product Name: Basiliximab Pharmaceutical Form: Powder for infusion* Other descriptive name: Basiliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐ Pharmaceutical form of the placebo: Powder for infusion* Route of administration of the placebo: Intravenous use

CONDITION:

Steroid‐refractory ulcerative colitis ; MedDRA version: 8.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative

PRIMARY OUTCOME:

Main Objective: Efficacy: ; Assess the efficacy, relative to placebo, of 40 mg basiliximab given intravenously, at 2 week intervals for a total of 3 doses, with concomitant oral corticosteroids, in subjects with steroid‐refractory, moderate to severe Ulcerative Colitis. A total of 3 doses will be administered during the 8 week duration of the trial. ; ; ; Safety: ; Evaluate the overall safety of this multiple‐dose regimen in this patient population.; Primary end point(s): The primary efficacy endpoint will be clinical remission at week 8.; ; Secondary efficacy endpoints will include:; ; • Clinical remission at week 4 ; • Clinical response at weeks 4 and 8; • Mucosal healing at weeks 4 and 8; • Use of rescue medication; • Hospitalization or colectomy; • Concomitant steroid use (median dose over time and cumulative dose) Secondary Objective: Secondary objectives are to assess: ; • Efficacy, relative to placebo, of basiliximab 20 mg, given with concomitant ; oral corticosteroids, according to the same schedule; • Safety of basiliximab 20 mg multiple‐dose regimen; • Pharmacokinetics of both basiliximab regimens in this population; • Immunogenicity of multiple doses of basiliximab through measurement of ; formation of antibodies to basiliximab, and monitoring for hypersensitivity ; reactions;

INCLUSION CRITERIA:

Subjects must satisfy all of the following inclusion criteria to be eligible for the study: 1. Male or female subjects, age =18 years and =75 years 2. Weight of 40 kg or greater 3. Signed a current IRB/IEC‐approved informed consent form 4. Diagnosis of ulcerative colitis confirmed through screening endoscopy performed no more than 3 days prior to day of randomization (Day ‐2 to Day 0, with randomization on Day 1). At the time of endoscopy, a rectal biopsy will be obtained and reviewed by a local pathologist to confirm histopathology compatible with the diagnosis of ulcerative colitis. Randomization can proceed without the screening biopsy result if a previous biopsy result compatible with ulcerative colitis is documented and available in the subject’s medical record. 5. Extent of disease must involve at least the left colon (i.e., greater than 15 cm beyond the anal verge as the endoscope is withdrawn) 6. Moderate to severe