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

NCT06859099 | Enrolling By Invitation Phase 3 FDA Drug

• 3 other identifiers: LTS17261U1111-1311-14322024-517032-22-00
• Study Type: interventional
• Target: 300
• Locations: 18 countries
• Sites: 43

Brief 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.

Conditions

Polyneuropathy, Inflammatory Demyelinating, Chronic

Outcome Measures

Primary Outcomes (1)

• Number of participants having any AEs, SAEs, adverse events leading to treatment discontinuation, AESIs, and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, ECGs, and vital signs during the study period

  adverse events: AEs, serious adverse events: SAEs, adverse events of special interest: AESIs, electrocardiograms: ECGs

  Up to End of Study (approx. 4 years)

Secondary Outcomes (6)

• Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)

  From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years)

• Percentage of participants experiencing improvement from baseline

  From Baseline to 3 years

• Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time

  From Baseline to 3 years

• Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time

  From Baseline to 3 years

• Change from baseline in grip strength (kilopascals; dominant hand) over time

  From Baseline to 3 years

Study Arms (1)

riliprubart

EXPERIMENTAL

Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP)

Drug: Riliprubart Prefilled Pen (PFP)

Interventions

Riliprubart Prefilled Pen (PFP) DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Also known as: SAR445088

riliprubart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are eligible to be included in the study only if all of the following criteria apply:
• 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.)
• 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.
• 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.

You may not qualify if:

• Participants are excluded from the study if any of the following criteria apply:
• Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation
• Clinical diagnosis of systemic lupus erythematosus (SLE)
• History of any hypersensitivity to riliprubart or any of its components, or severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody
• Any country-related specific regulation that would prevent the participant from entering the study
• Accommodation in an institution because of regulatory or legal order; for instance, a prisoner or participant who is legally institutionalized
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (44)

Alabama Neurology Associates- Site Number : 8400019

Homewood, Alabama, 35209, United States

Location

University of Kansas Medical Center (KUMC)- Site Number : 8400010

Westwood, Kansas, 66205-2003, United States

Location

Investigational Site Number : 0320003

Buenos Aires, 1221, Argentina

Location

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

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Investigational Site Number : 1240001

Gatineau, Quebec, J8Y 1W2, Canada

Location

Investigational Site Number : 1240002

Québec, Quebec, G1E 7G9, Canada

Location

Investigational Site Number : 1520003

Lo Barnechea, Reg Metropolitana de Santiago, 7691236, Chile

Location

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, 8207257, Chile

Location

Investigational Site Number : 1560013

Beijing, 100034, China

Location

Investigational Site Number : 1560005

Beijing, 100053, China

Location

Investigational Site Number : 1560011

Chengdu, 610072, China

Location

Investigational Site Number : 1560002

Fuzhou, 350001, China

Location

Investigational Site Number : 1560012

Guangzhou, 510000, China

Location

Investigational Site Number : 1560001

Shanghai, 200040, China

Location

Investigational Site Number : 1560003

Wuhan, 430030, China

Location

Investigational Site Number : 1560006

Wuhan, 430060, China

Location

Investigational Site Number : 2030004

Brno, 625 00, Czechia

Location

Investigational Site Number : 2030001

Prague, 128 08, Czechia

Location

Investigational Site Number : 2080002

Aarhus, 8200, Denmark

Location

Investigational Site Number : 2500007

Bordeaux, 33076, France

Location

Investigational Site Number : 2500001

Le Kremlin-Bicêtre, 94270, France

Location

Investigational Site Number : 2500002

Marseille, 13885, France

Location

Investigational Site Number : 2500004

Paris, 75013, France

Location

Investigational Site Number : 2760002

Göttingen, 37075, Germany

Location

Investigational Site Number : 2760004

Tübingen, 72076, Germany

Location

Investigational Site Number : 3800003

Genoa, Genova, 16132, Italy

Location

Investigational Site Number : 3800001

Milan, Milano, 20132, Italy

Location

Investigational Site Number : 3800004

Rozzano, Milano, 20089, Italy

Location

Investigational Site Number : 3800002

Rome, Roma, 00168, Italy

Location

Investigational Site Number : 3800005

Pavia, 27100, Italy

Location

Investigational Site Number : 3800007

Pisa, 56126, Italy

Location

Investigational Site Number : 3920012

Higashi-Matsuyama, Saitama, 355-0005, Japan

Location

Investigational Site Number : 2500005

Toyama, 939-2716, Japan

Location

Investigational Site Number : 5280001

Amsterdam, 1105 AZ, Netherlands

Location

Investigational Site Number : 6160001

Lublin, Lublin Voivodeship, 20-954, Poland

Location

Investigational Site Number : 6200004

Lisbon, 1150-199, Portugal

Location

Investigational Site Number : 6880001

Belgrade, 11000, Serbia

Location

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, 02841, South Korea

Location

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña], 08041, Spain

Location

Investigational Site Number : 7240004

Majadahonda, Madrid, 28222, Spain

Location

Investigational Site Number : 7240002

Barcelona, 08035, Spain

Location

Investigational Site Number : 7240008

Málaga, 29010, Spain

Location

Investigational Site Number : 7240003

Valencia, 46026, Spain

Location

Investigational Site Number : 7520001

Stockholm, 113 65, Sweden

Location

Related Links

• LTS17261 Plain Language Results Summary

MeSH Terms

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Condition Hierarchy (Ancestors)

Polyradiculoneuropathy; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 3, 2029
• Study Completion (Estimated): October 3, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2); CZ (2); IT (6); CA (2); CL (2); PL (1); AR (1); JP (2); PT (1); BR (1); NL (1); SE (1); DE (2); KR (1); FR (4); DK (1); ES (5); CN (8)