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

NCT ID: NCT06859099

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-10-03

Brief Summary

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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.

Detailed Description

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This is a single-arm study. All participants transitioning to Study LTS17261 will receive riliprubart weekly for up to 3 years, or until commercialization of riliprubart for the treatment of CIDP or termination of the riliprubart clinical development program for the treatment of CIDP, or the local availability of other options for long-term treatment with riliprubart, whichever comes first.

The total number of study visits will be 12.

Conditions

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Polyneuropathy, Inflammatory Demyelinating, Chronic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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riliprubart

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

Group Type EXPERIMENTAL

Riliprubart Prefilled Pen (PFP)

Intervention Type DRUG

Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Interventions

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Riliprubart Prefilled Pen (PFP)

Pharmaceutical form: Solution Route of administration: Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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SAR445088

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Alabama Neurology Associates- Site Number : 8400019

Homewood, Alabama, United States

Site Status RECRUITING

University of Kansas Medical Center- Site Number : 8400010

Kansas City, Kansas, United States

Site Status RECRUITING

Investigational Site Number : 1240001

Gatineau, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 1240002

Québec, Quebec, Canada

Site Status RECRUITING

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Site Status RECRUITING

Investigational Site Number : 1560013

Beijing, , China

Site Status RECRUITING

Investigational Site Number : 1560005

Beijing, , China

Site Status RECRUITING

Investigational Site Number : 1560011

Chengdu, , China

Site Status RECRUITING

Investigational Site Number : 1560002

Fuzhou, , China

Site Status RECRUITING

Investigational Site Number : 1560001

Shanghai, , China

Site Status RECRUITING

Investigational Site Number : 1560003

Wuhan, , China

Site Status RECRUITING

Investigational Site Number : 2080002

Aarhus, , Denmark

Site Status RECRUITING

Investigational Site Number : 2500007

Bordeaux, , France

Site Status RECRUITING

Investigational Site Number : 2500001

Le Kremlin-Bicêtre, , France

Site Status RECRUITING

Investigational Site Number : 2500002

Marseille, , France

Site Status RECRUITING

Investigational Site Number : 2500004

Paris, , France

Site Status RECRUITING

Investigational Site Number : 2760002

Göttingen, , Germany

Site Status RECRUITING

Investigational Site Number : 2760004

Tübingen, , Germany

Site Status RECRUITING

Investigational Site Number : 3800003

Genoa, Genova, Italy

Site Status RECRUITING

Investigational Site Number : 3800001

Milan, Milano, Italy

Site Status RECRUITING

Investigational Site Number : 3800004

Rozzano, Milano, Italy

Site Status RECRUITING

Investigational Site Number : 3800002

Rome, Roma, Italy

Site Status RECRUITING

Investigational Site Number : 5280001

Amsterdam, , Netherlands

Site Status RECRUITING

Investigational Site Number : 6160001

Lublin, Lublin Voivodeship, Poland

Site Status RECRUITING

Investigational Site Number : 6880001

Belgrade, , Serbia

Site Status RECRUITING

Investigational Site Number : 4100003

Seoul, Seoul-teukbyeolsi, South Korea

Site Status RECRUITING

Investigational Site Number : 7240002

Barcelona, Barcelona [Barcelona], Spain

Site Status RECRUITING

Investigational Site Number : 7240001

Barcelona, Catalunya [Cataluña], Spain

Site Status RECRUITING

Investigational Site Number : 7240004

Majadahonda, Madrid, Spain

Site Status RECRUITING

Investigational Site Number : 7240003

Valencia, , Spain

Site Status RECRUITING

Countries

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United States Canada Chile China Denmark France Germany Italy Netherlands Poland Serbia South Korea Spain

Central Contacts

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Trial Transparency email recommended (Toll free for US & Canada)

Role: CONTACT

Phone: 800-633-1610

Email: [email protected]

Related Links

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https://www.trialsummaries.com/Study/StudyDetails?id=26640&tenant=MT_SNY_9011

LTS17261 Plain Language Results Summary

Other Identifiers

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U1111-1311-1432

Identifier Type: OTHER

Identifier Source: secondary_id

2024-517032-22-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

LTS17261

Identifier Type: -

Identifier Source: org_study_id