Long-term treatment with riliprubart for chronic inflammatory demyelinating polyneuropathy
Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This study is testing if a medication called riliprubart is safe and effective for adults with chronic inflammatory demyelinating polyneuropathy over a long period of time.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 3 sites (Gatineau, Quebec and 2 other locations) |
| Trial ID | NCT06859099 on ClinicalTrials.gov |
What this trial studies
This Phase 3 extension study evaluates the long-term safety and efficacy of riliprubart in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who have previously participated in related studies. Participants will receive riliprubart weekly for up to three years, with a total of 12 study visits planned. The study aims to gather data on the treatment's effects over an extended period, including a follow-up phase after treatment discontinuation. Approximately 300 participants will be enrolled globally to assess the ongoing benefits and safety of the medication.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with chronic inflammatory demyelinating polyneuropathy who have completed prior studies involving riliprubart.
Not a fit: Patients who have not previously received riliprubart or those with other forms of neuropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a long-term treatment option for patients suffering from CIDP, potentially improving their quality of life.
How similar studies have performed: Other studies involving riliprubart have shown promise, making this approach a continuation of previously explored treatment options.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Participants with chronic inflammatory demyelinating polyneuropathy (CIDP) currently receiving riliprubart who completed treatment in Part B of Study PDY16744, Study EFC17236, or Study EFC18156. (Participants receiving riliprubart in Part C of PDY16744 are eligible after completing the Part C End of Treatment visit.) 2. All participants must agree to use contraception methods during and after the study as required. Contraceptive use by men and women participating in the study should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 3. Participant must be capable of giving signed informed consent as described in Appendix 1 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation 2. Clinical diagnosis of systemic lupus erythematosus (SLE) 3. History of any hypersensitivity to riliprubart or any of its components, or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody 4. Any country-related specific regulation that would prevent the participant from entering the study 5. Accommodation in an institution because of regulatory or legal order; for instance, a prisoner or participant who is legally institutionalized 6. Unsuitability for participation as judged by the Investigator, whatever the reason, including: medical or clinical condition, potential risk of participant noncompliance with study procedures, or any other clinically significant change in the participants' medical condition
Where this trial is running
Gatineau, Quebec and 2 other locations
- Investigational Site Number : 1240001 — Gatineau, Quebec, Canada (Recruiting)
- Investigational Site Number : 1560001 — Shanghai, China (Recruiting)
- Investigational Site Number : 1560003 — Wuhan, China (Recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.