Protocol MI-CP200 (Amendment 2, dated 23Sep2010)
Research type
Research Study
Full title
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety and Tolerability of MEDI-551 in Scleroderma
IRAS ID
67538
Contact name
Christopher Denton
Sponsor organisation
MedImmune, LLC
Eudract number
2010-022312-39
Clinicaltrials.gov Identifier
Research summary
Currently, there is a tremendous unmet medical need for disease-modifying therapies in scleroderma. Given the potential role of CD19 in the pathogenesis of this disease along with the robust nonclinical data of MEDI-551, there is a strong rationale for developing MEDI-551 for the treatment of subjects with scleroderma. MI-CP200 is a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety and tolerability of escalating single IV doses of MEDI-551 in adult subjects with scleroderma who have at least moderate skin thickening in an area suitable for repeat biopsy. Approximately 20 sites in the United States of America (USA), Canada, and Europe will participate in the study. Subjects will receive their dose of study drug via IV infusion within 3 weeks of signing the informed consent form and will return to the clinic for follow-up 2 days, 1 week, 2 weeks, 1 month, 2 months, and 3 months (the last visit and the end of the study) after the dose. The study will last 105 days in total. During these visits, blood/serum will be collected for the monitoring of safety lab values and B-cell numbers as well as to evaluate serum concentrations of MEDI-551 and the presence of anti-MEDI-551 antibodies. In addition, subjects will undergo pulmonary function tests, skin biopsies, and clinician-rated disease activity assessments including patient-reported outcomes. If following the last visit a subject's B-cell numbers do not show adequate recovery, subjects will be asked to return to the study site every month for 3 months and every 3 months thereafter or until the B-cell count in peripheral blood returns to at least 25% of the baseline value or is at least 50% of the Lower Limit of Normal (LLN). Follow-up may extend beyond 1 year.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
11/H0713/10
Date of REC Opinion
28 Feb 2011
REC opinion
Further Information Favourable Opinion