A Phase 2 Study of Obexelimab in Patients with Relapsing MS

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab, in Patients with Relapsing Multiple Sclerosis

• IRAS ID

  1010092

• Contact name

  Lisa Crockett

• Contact email

  Lisa.Crockett@zenasbio.com

• Sponsor organisation

  Zenas BioPharma (USA) LLC

• Eudract number

  2024-512707-40

• ISRCTN Number

  ISRCTN78327800

• Research summary

  MS Is a potentially disabling autoimmune disease that affects the central nervous system (brain and spinal cord). B cells play an important role in the autoimmune disease mechanism. Obexelimab, an experimental study drug, is an antibody developed for the treatment of such autoimmune disorders. The drug acts by binding to the B cell surface and decreases B cell activity.
  The purpose of this study is to evaluate the safety and effectiveness of obexelimab, on MS. In Part A, obexelimab or placebo as subcutaneous injections, will be administered at random. Two thirds of the patients will receive obexelimab and one third will receive placebo, once weekly for 12 weeks. After week 12, all patients will receive obexelimab in Part B, for an additional 12 weeks.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  24/LO/0508

• Date of REC Opinion

  5 Aug 2024

• REC opinion

  Further Information Favourable Opinion