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Clinical Trials in the UK / NCT06859099
Enrolling by invitation Phase 3

Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP

NCT06859099 · tracked via the Priya Life Science UK tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2025-04-01
Last updated
2026-09-18

Condition(s) studied

Polyneuropathy, Inflammatory Demyelinating, Chronic

Investigational drug(s) / intervention(s)

Riliprubart Prefilled Pen (PFP)

Riliprubart Prefilled Pen (PFP): Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
Alabama Neurology Associates- Site Number : 8400019 Homewood Alabama
Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014 Scottsdale Arizona
University of Kansas Medical Center- Site Number : 8400010 Kansas City Kansas
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022 Philadelphia Pennsylvania
Investigational Site Number : 0320003 Buenos Aires Argentina
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006 Brasília Federal District
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004 Ribeirão Preto São Paulo
Investigational Site Number : 1000002 Blagoevgrad Bulgaria
Investigational Site Number : 1240001 Gatineau Quebec
Investigational Site Number : 1240002 Québec Quebec
Investigational Site Number : 1520003 Lo Barnechea Reg Metropolitana de Santiago
Investigational Site Number : 1520002 Puente Alto Reg Metropolitana de Santiago
Investigational Site Number : 1560013 Beijing China
Investigational Site Number : 1560005 Beijing China
Investigational Site Number : 1560009 Changsha China
Investigational Site Number : 1560011 Chengdu China
Investigational Site Number : 1560002 Fuzhou China
Investigational Site Number : 1560012 Guangzhou China
Investigational Site Number : 1560014 Hangzhou China
Investigational Site Number : 1560001 Shanghai China
Investigational Site Number : 1560003 Wuhan China
Investigational Site Number : 1560006 Wuhan China
Investigational Site Number : 2030004 Brno Czechia
Investigational Site Number : 2030001 Prague Czechia
Investigational Site Number : 2080002 Aarhus Denmark
Investigational Site Number : 2080001 Copenhagen Denmark
Investigational Site Number : 2500007 Bordeaux France
Investigational Site Number : 2500001 Le Kremlin-Bicêtre France
Investigational Site Number : 2500002 Marseille France
Investigational Site Number : 2500004 Paris France
Investigational Site Number : 2760002 Göttingen Germany
Investigational Site Number : 2760003 Münster Germany
Investigational Site Number : 2760004 Tübingen Germany
Investigational Site Number : 3800003 Genoa Genova
Investigational Site Number : 3800001 Milan Milano
Investigational Site Number : 3800004 Rozzano Milano
Investigational Site Number : 3800002 Rome Roma
Investigational Site Number : 3800005 Pavia Italy
Investigational Site Number : 3800007 Pisa Italy
Investigational Site Number : 3920012 Higashi-Matsuyama Saitama

+ 19 more sites — see the full list on the official registry below.

More Sanofi trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06859099 on ClinicalTrials.gov ↗ ← All trials in the UK