A Phase 3, Randomized, Double-Blind, Study Evaluating Efficacy And Safety Of Riliprubart Versus Intravenous Immunoglobulin (Ivig) In Participants With Chronic Inflammatory Demyelinating Polyneuropathy
Posted Date: Sep 11, 2025
- Investigator: Hani Kushlaf
- Specialties: Neurology, Neuromuscular Disorders
- Type of Study: Drug
This Phase 3 study will be a double-blind, double-dummy, noninferiority, and superiority design with sample size re-estimation. This study has 2 parts: Part A will evaluate efficacy and safety of riliprubart during a 24 week, randomized, double-blinded treatment period; Part B will evaluate long-term efficacy, safety, and tolerability of riliprubart during a 24 week open-label treatment period. This Phase 3 trial will include IVIg-treated participants, randomized with a 1:1 ratio to either receive riliprubart or continue IVIg (active comparator) in Part A and then switch to receive open-label riliprubart in Part B.
Criteria:
Participant Must Be =18 Years Old At The Time Of Signing The Informed Consent. Participant Must Have Cidp Or Possible Cidp Criteria, Based On European Academy Of Neurology/Peripheral Nerve Society (Ean/Pns) Task Force Cidp Guidelines, Second Revision (2021; 33). Participant Must Have Responded To Ivig In The Past 5 Years.Participant Must Be On A Stable Maintenance Dosage Of Ivig, Defined As No Change Greater Than 10% In Frequency Or Dose Of Ivig Within 8 Weeks Prior To Screening, And Remaining Stable Until Baseline.
Keywords:
Cidp
For More Information:
Hannah Fisher
5135584456
fisherhh@ucmail.uc.edu