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ENROLLING BY INVITATION

NCT06859099

PHASE3

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2025-04-01

Completion Date

2029-10-03

Last Updated

2026-03-27

Healthy Volunteers

Conditions

Polyneuropathy, Inflammatory Demyelinating, Chronic

Interventions

DRUG

Riliprubart Prefilled Pen (PFP)

Pharmaceutical form: Solution Route of administration: Subcutaneous injection

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.

Locations (43)

Alabama Neurology Associates- Site Number : 8400019

Homewood, Alabama, United States

University of Kansas Medical Center- Site Number : 8400010

Kansas City, Kansas, United States

Investigational Site Number : 0320003

Buenos Aires, Argentina

Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004

Ribeirão Preto, São Paulo, Brazil

Investigational Site Number : 1240001

Gatineau, Quebec, Canada

Investigational Site Number : 1240002

Québec, Quebec, Canada

Investigational Site Number : 1520003

Lo Barnechea, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560013

Beijing, China

Investigational Site Number : 1560005

Beijing, China

Investigational Site Number : 1560011

Chengdu, China

Investigational Site Number : 1560002

Fuzhou, 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 : 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 : 2760004

Tübingen, Germany

Investigational Site Number : 3800003

Genoa, Genova, Italy

Investigational Site Number : 3800001

Milan, Milano, Italy

Investigational Site Number : 3800004

Rozzano, Milano, Italy

Investigational Site Number : 3800002

Rome, Roma, Italy

Investigational Site Number : 3800005

Pavia, Italy

Investigational Site Number : 3800007

Pisa, Italy

Investigational Site Number : 3920012

Higashi-Matsuyama, Saitama, Japan

Investigational Site Number : 2500005

Toyama, Japan

Investigational Site Number : 5280001

Amsterdam, Netherlands

Investigational Site Number : 6160001

Lublin, Lublin Voivodeship, Poland

Investigational Site Number : 6200004

Lisbon, Portugal

Investigational Site Number : 6880001

Belgrade, Serbia

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña], Spain

Investigational Site Number : 7240004

Majadahonda, Madrid, Spain

Investigational Site Number : 7240002

Barcelona, Spain

Investigational Site Number : 7240008

Málaga, Spain

Investigational Site Number : 7240003

Valencia, Spain

Investigational Site Number : 7520001

Stockholm, Sweden