Phase 1 Randomized Study of MEDI-551 in Subjects with Relapsing Forms

• Research type

  Research Study

• Full title

  A Phase 1 Randomized Study of MEDI-551 in Subjects with Relapsing Forms of Multiple Sclerosis

• IRAS ID

  99189

• Contact name

  Gavin Giovannoni

• Sponsor organisation

  MedImmune LLC

• Eudract number

  2011-005475-16

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Multiple Sclerosis (MS) is a condition of the central nervous system. Certain white cells in the blood called B-lymphocytes or B-cells are believed to play a role in the disease of MS. MEDI-551, the drug being tested in this study, is a man-made human monoclonal antibody that reduces the number of B cells in the blood. A decrease in the number of B-cells in the blood has been associated with a lower relapse rate and improvement in symptoms of disease. This is a Phase 1/2, multicentre, adaptive design study to evaluate the safety, tolerability, and efficacy of MEDI-551 in adult subjects with Relapsing-Remitting Multiple Sclerosis (RRMS). This study consists of:- Phase 1 part: Dose-escalation Phase: Randomised, double-blind with 4 cohorts of 8 subjects randomised in a 6:2 ratio to receive a single course of MEDI-551 (30, 100, 300, or 900 mg) or placebo (dummy drug). Parallel-dose part: Randomized, double-blind with 5 groups of 12 subjects each randomised in a 1:1:1:1:1 ratio to receive in a single course of MEDI-551 (30, 100, 300, or 900 mg) or placebo. Phase 2 Part: Designed similarly to the parallel-dose phase of the Phase 1 part but excludes placebo and adds the active comparator Avonex. There will be approximately 92 participants in Phase 1 and 420 in phase 2. The study will be carried out in approximately 50 research centres in North America and Europe. Participants will be in the Phase 1 part for about 32 weeks or the Phase 2 part for about 52 weeks. In addition there will be Long-term Follow-up Period for B-cell Recovery. Participants will continue to be followed long-term on an annual basis. This study involves procedures including: Physical examination; vital signs; Medical History; ECG, Chest x-ray; Gd-enhancing MRI scan; lab tests; neurological function and level of disability tests; study drug administration.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/0720

• Date of REC Opinion

  25 Jul 2012

• REC opinion

  Further Information Favourable Opinion