Phase 3 study evaluating efficacy and safety of riliprubart versus IVIg in CIDP
Research type
Research Study
Full title
A Phase 3, randomized, double-blind, study evaluating efficacy and safety of riliprubart versus intravenous immunoglobulin (IVIg) in participants with chronic inflammatory demyelinating polyneuropathy
IRAS ID
1009620
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Développement
Eudract number
2023-508338-33
Clinicaltrials.gov Identifier
Research summary
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare condition where the body’s immune system attacks the myelin that covers and protects nerves. People with CIDP usually experience weakness in their muscles, making it hard to walk. They might also have strange sensations like tingling, numbness, or difficulties with coordination. It often leads to increased disability, which may require physical therapy, special devices like braces, or even a wheelchair.
Available immunoglobulin treatments or IVIg for CIDP are not always effective, may provide limited effectiveness, may cause unpleasant side effects, and require long term treatment management.
This study compares how well a new investigational compound called riliprubart works and how safe and effective it is compared with IVIg for CIDP. Riliprubart is a type of medicine that blocks a particular part of our body’s defense system from working too much. IVIg is used in this study as a comparator drug because it is an existing treatment for CIDP.
This study has two parts. People in this study will get either the medicine riliprubart or IVIg in the first part (24 weeks) without knowing what they have received. Neither the people taking part, nor the study doctors will know which treatment is given (riliprubart or IVIg). This is done to make sure that the study results are not influenced in any way. The treatment will be randomly chosen for each participant meaning determined by chance using a computer program. This works like flipping a coin. All people will get riliprubart in the second part (24 weeks).
The study will last approximately 109 weeks and there will be about 18 visits. People aged at least 18 years who are regularly treated with IVIg for CIDP can be included in the study. People with certain current or past medical problems or medications that would cause a health problem during the study cannot participate.
This study will take place in approximately 25 countries.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
24/EM/0085
Date of REC Opinion
21 May 2024
REC opinion
Further Information Favourable Opinion