LTS17261

• Research type

  Research Study

• Full title

  Long-term extension study to evaluate the safety and efficacy of riliprubart (SAR445088) in participants with chronic inflammatory demyelinating polyneuropathy (CIDP)

• IRAS ID

  1012122

• Contact name

  Patrick Maury

• Contact email

  patrick.maury@sanofi.com

• Sponsor organisation

  Sanofi-Aventis Recherche et Developpement

• Eudract number

  2024-517032-22

• Clinicaltrials.gov Identifier

  NCT06859099

• Research summary

  Research Summary
  Study LTS17261 allows patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) who previously received riliprubart in clinical trials to continue treatment long-term. CIDP is a rare disorder causing weakness and numbness in limbs due to nerve inflammation. The study aims to gather safety data and assess ongoing effectiveness of riliprubart over an extended period.

  Research Question and Importance
  This study examines whether riliprubart remains safe and effective for long-term CIDP treatment. This matters because CIDP is chronic, often requiring ongoing therapy, and new treatment options with good long-term safety profiles could significantly improve patients' quality of life.

  Disease Area and Treatment
  CIDP is an autoimmune disorder where the immune system attacks nerve coverings. Riliprubart (300mg) is administered weekly as a subcutaneous injection using a prefilled pen designed for self-administration.

  Eligibility and Study Sites
  Eligible participants must have completed treatment in previous riliprubart studies (PDY16744, EFC17236, or EFC18156). Up to 283 participants will enroll at multiple global medical centers specializing in neurological disorders.

  Study Duration and Experience
  The study lasts up to 3 years. Participants will:
  • Receive weekly self-administered injections
  • Attend regular clinic visits
  • Complete assessments of nerve function and disability
  • Have blood tests for safety monitoring
  The study continues until riliprubart becomes commercially available, the development program ends, or other treatment options become locally available.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  25/LO/0401

• Date of REC Opinion

  5 Aug 2025

• REC opinion

  Further Information Favourable Opinion