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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

10 Jun 2025 → ongoing

Decision date (initial)

2025-04-24

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2024-517032-22-00

WHO UTN

U1111-1311-1432

ClinicalTrials.gov

NCT06859099

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To determine the long-term safety and tolerability of riliprubart in participants with CIDP.

Secondary objectives 2

1. To evaluate the long-term efficacy of riliprubart with the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale
2. To evaluate long-term efficacy of riliprubart with additional measures of functional disability and strength

Conditions and MedDRA coding

Immune system diseases.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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 ICF and in this protocol.

Exclusion criteria 6

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 6

1. Percentage of participants relapse-free since the first dose of riliprubart in the parent study (PDY16744, EFC17236, or EFC18156).
2. Percentage of participants experiencing improvement from baseline.
3. Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time.
4. Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time.
5. Change from baseline in grip strength (kilopascals; dominant hand) over time.
6. Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 5

Locations

14 EU/EEA countries · 60 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 93 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

17 submissions — initial application plus substantial / non-substantial modifications