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Long-term extension study to evaluate the safety and efficacy of riliprubart (SAR445088) in participants with chronic inflammatory demyelinating polyneuropathy (CIDP)

Long-term safety and efficacy study of riliprubart in participants with CIDP
(LTS)

Obara Kentaro

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

clinical-trials-jp@sanofi.com

Clinical Study Unit

Sanofi K.K.

Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan

+81-3-6301-3670

clinical-trials-jp@sanofi.com

Recruiting

Mar. 12, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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.

Both

Polyneuropathy, Inflammatory Demyelinating, Chronic

Drug: Riliprubart Prefilled Pen (PFP) (SAR445088)
Pharmaceutical form: Solution, Route of administration: Subcutaneous injection

Study Arm:
- Experimental: Riliprubart
Participants receive subcutaneous injection with a riliprubart PFP.
- - Interventions: Riliprubart PFP

Number of participants having any adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment discontinuation, adverse events of special interest (AESIs), and potentially clinically significant abnormalities (PCSAs) in safety laboratory tests, electrocardiograms (ECGs), and vital signs during the study period
[Time Frame: Up to End of Study (approx. 4 years)]

1. Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156)
[Time Frame: From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years)]
To estimate the relapse-free rate, time to first relapse, defined as time from first dose of riliprubart in the parent study to the first relapse since riliprubart initiation, will be derived for each participant. Relapse since riliprubart initiation is defined as increase of 1 point or more in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score relative to the visit for the first dose of riliprubart in the parent study.
2. Percentage of participants experiencing improvement from baseline
[Time Frame: From Baseline to 3 years]
Improvement is defined as a decrease of 1 point or more in adjusted INCAT disability score relative to baseline of the current study, Study LTS17261.
3. Change from baseline in adjusted INCAT disability score over time
[Time Frame: From Baseline to 3 years]
4. Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time
[Time Frame: From Baseline to 3 years]
5. Change from baseline in grip strength (kilopascals; dominant hand) over time
[Time Frame: From Baseline to 3 years]
6. Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time
[Time Frame: From Baseline to 3 years]

Jan. 30, 2026

Yes

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

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