Ulcerative Colitis
Conditions
Keywords
Ulcerative Colitis
Brief summary
Primary Objective Safety: assess the safety of basiliximab 40 mg, given every 4 weeks, in subjects with ulcerative colitis who completed previous basiliximab studies. Secondary Objectives: evaluate the efficacy and assess the immunogenicity of this multiple-dose maintenance regimen in this population
Interventions
DRUGBasiliximab
Study Drug: basiliximab 40 mg, given as a short intravenous infusion Dosing Schedule: once every 4 weeks Concomitant Therapy: Oral corticosteroids (prednisone or equivalent) will be tapered during the first few months of the study participation Duration of Study Participation: The duration of individual study participation will vary.
Sponsors
Cerimon Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Previously met eligibility criteria in the previous basiliximab UC study 2. Must have a total Mayo score at entry consistent with clinical response or clinical remission. 3. Signed a current IRB/IEC-approved informed consent form 4. 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. 5. 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.
Exclusion criteria
1. 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 2. Subject is currently receiving a restricted/prohibited concomitant medication 3. Subject has undergone colectomy (total, or subtotal) 4. Subject is pregnant or breast-feeding 5. Prior noncompliance with previous study visit schedule and requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the safety of basiliximab in subjects with ulcerative colitis | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the efficacy and assess the immunogenicity of t his multiple-dose maintenance regimen in this population | 1 year |
Countries
United Kingdom
Outcome results
None listed