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NCT06859099: LTS
Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
Phase 3 trial testing Riliprubart Prefilled Pen (PFP) in Polyneuropathy, Inflammatory Demyelinating, Chronic in 300 participants. Enrolling by invitation.
3 October 2029
Quick facts
| Lead sponsor | Sanofi |
|---|---|
| Phase | Phase 3 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 1 April 2025 |
| Primary completion | 3 October 2029 |
| Estimated completion | 3 October 2029 |
| Sites | 44 locations across Italy, Japan, Poland, South Korea, Denmark, Netherlands, Sweden, Portugal |
Drugs / interventions tested
- Riliprubart Prefilled Pen (PFP) — full drug profile →
Conditions studied
- Polyneuropathy, Inflammatory Demyelinating, Chronic — all drugs for Polyneuropathy, Inflammatory Demyelinating, Chronic →
Sponsor
Sanofi — full company profile →
Who can join
18 and older, any sex, with Polyneuropathy, Inflammatory Demyelinating, Chronic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is a Phase 3 extension, global, multicenter open-label study. The purpose of this study is to evaluate long-term safety and efficacy of riliprubart in adult participants with chronic inflammatory demyelinating polyneuropathy (CIDP) who have completed Part B in 1 of 3 parent studies (PDY16744, EFC17236, or EFC18156) and wish to continue treatment with riliprubart. Up to approximately 300 participants will be enrolled to continue receiving treatment with riliprubart. The duration of participation for each participant will be up to approximately 4 years, including posttreatment follow-up. The treatment duration will be up to approximately 3 years. A participant who discontinues riliprubart treatment at any time during the study will be followed for safety for a minimum of 55 weeks after the last dose of riliprubart received.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Advances in the treatment of autoimmune nodopathy: based on treatment strategies of CIDP.
Pang ZD, Sun H, Wei XJ, Nie CP, et al · · 2026 · PMID 41890726 · DOI 10.3389/fimmu.2026.1735745
Verify or expand the search:
- PubMed search for NCT06859099
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Polyneuropathy, Inflammatory Demyelinating, Chronic
Currently open trials in the same condition.
- NCT06968975 — Real-world Study of Treatment Outcomes in Chronic Inflammatory Demyelinating Polyneuropathy/Polyradiculoneuropathy (CIDP · recruiting
- NCT06290128 — A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy ( · Phase 3 · recruiting
Other Sanofi trials
Trials by the same sponsor.
- NCT07282795 — Post-marketing Surveillance Study for the Safety of Efluelda® Pre-filled Syringe · not yet recruiting
- NCT06694025 — Post-marketing Surveillance Study for the Safety of Efluelda Tetra Pre-filled Syringe. · not yet recruiting
- NCT07222189 — A Study to Investigate the Long-term Safety, Tolerability and Efficacy of Balinatunfib in Participants With Crohn's Dise · Phase 2 · not yet recruiting
- NCT07484230 — A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Adult Japanese Partic · Phase 3 · not yet recruiting
- NCT07547436 — A Study to Access Activity and Safety With SAR445399 Compared With Placebo in Participants Aged 18 to 80 Years of Age Wi · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06859099 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanofi
- Last refreshed: 16 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06859099.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing