Polyneuropathy, Inflammatory Demyelinating, ChronicPhase 3LTSNCT06859099
Long-term Safety and Efficacy Study of Riliprubart in Participants With CIDP
A Phase 3 study testing Riliprubart Prefilled Pen (PFP) in people with Polyneuropathy, Inflammatory Demyelinating, Chronic, run by Sanofi at 62 sites in 24 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyneuropathy, Inflammatory Demyelinating, Chronic
- What is being tested?
- Riliprubart Prefilled Pen (PFP)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 62 sitesin 24 countries
- Study dates
- 1 Apr 2025to 3 Oct 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
62 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
62 sites in 24 countries
China10 sites
Investigational Site Number : 1560013
Beijing, 100034
Investigational Site Number : 1560005
Beijing, 100053
Investigational Site Number : 1560009
Changsha, 410008
Investigational Site Number : 1560011
Chengdu, 610072
Investigational Site Number : 1560002
Fuzhou, 350001
Investigational Site Number : 1560012
Guangzhou, 510000
Investigational Site Number : 1560014
Hangzhou, 310009
Investigational Site Number : 1560001
Shanghai, 200040
Investigational Site Number : 1560003
Wuhan, 430030
Investigational Site Number : 1560006
Wuhan, 430060
France6 sites
Investigational Site Number : 2500007
Bordeaux, 33076
Investigational Site Number : 2500001
Le Kremlin-Bicêtre, 94270
Investigational Site Number : 2500002
Marseille, 13885
Investigational Site Number : 2500005
Montpellier, 34090
Investigational Site Number : 2500006
Nice, 06001
Investigational Site Number : 2500004
Paris, 75013
Italy6 sites
Investigational Site Number : 3800003
Genoa, Genova, 16132
Investigational Site Number : 3800001
Milan, Milano, 20132
Investigational Site Number : 3800005
Pavia, 27100
Investigational Site Number : 3800007
Pisa, 56126
Investigational Site Number : 3800002
Rome, Roma, 00168
Investigational Site Number : 3800004
Rozzano, Milano, 20089
Spain6 sites
Investigational Site Number : 7240002
Barcelona, Catalunya [Cataluña], 08035
Investigational Site Number : 7240001
Barcelona, Catalunya [Cataluña], 08041
Investigational Site Number : 7240004
Majadahonda, Madrid, 28222
Investigational Site Number : 7240008
Málaga, 29010
Investigational Site Number : 7240006
Pamplona, Navarre, 31008
Investigational Site Number : 7240003
Valencia, 46026
United States4 sites
Alabama Neurology Associates- Site Number : 8400019
Homewood, Alabama, 35209
University of Kansas Medical Center- Site Number : 8400010
Kansas City, Kansas, 66160
Penn Medicine: University of Pennsylvania Health System- Site Number : 8400022
Philadelphia, Pennsylvania, 19104
Honor Health Scottsdale Osborn Medical Center- Site Number : 8400014
Scottsdale, Arizona, 85251
Brazil3 sites
L2IP - Instituto de Pesquisas Clínicas- Site Number : 0760006
Brasília, Federal District, 70200-730
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto- Site Number : 0760004
Ribeirão Preto, São Paulo, 14049-900
PSEG Centro de Pesquisa Clínica- Site Number : 0760009
São Paulo, 04038-002
Germany3 sites
Investigational Site Number : 2760002
Göttingen, 37075
Investigational Site Number : 2760003
Münster, 48149
Investigational Site Number : 2760004
Tübingen, 72076
Japan3 sites
Investigational Site Number : 3920011
Bunkyo-Ku, Tokyo, 113-8510
Investigational Site Number : 3920012
Higashi-Matsuyama, Saitama, 355-0005
Investigational Site Number : 3920008
Kodaira, Tokyo, 187-8551
Canada2 sites
Investigational Site Number : 1240001
Gatineau, Quebec, J8Y 1W2
Investigational Site Number : 1240002
Québec, Quebec, G1E 7G9
Chile2 sites
Investigational Site Number : 1520003
Lo Barnechea, Reg Metropolitana de Santiago, 7691236
Investigational Site Number : 1520002
Puente Alto, Reg Metropolitana de Santiago, 8207257
Czechia2 sites
Investigational Site Number : 2030004
Brno, 625 00
Investigational Site Number : 2030001
Prague, 128 08
Denmark2 sites
Investigational Site Number : 2080002
Aarhus, 8200
Investigational Site Number : 2080001
Copenhagen, 2100
Turkey (Türkiye)2 sites
Investigational Site Number : 7920001
Istanbul, 34093
Investigational Site Number : 7920003
Konya, 42075
Netherlands1 site
Investigational Site Number : 5280001
Amsterdam, 1105 AZ
Poland1 site
Investigational Site Number : 6160001
Lublin, Lublin Voivodeship, 20-954
South Korea1 site
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 02841
United Kingdom1 site
Investigational Site Number : 8260001
Oxford, Oxfordshire, OX3 9DU
About this study
Official title: Long-term Extension Study to Evaluate the Safety and Efficacy of Riliprubart (SAR445088) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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.
Read the detailed description
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.
- Being tested
- Riliprubart Prefilled Pen (PFP)
- Medical subject headings
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Riliprubart Prefilled Pen (PFP)Drug
Also called SAR445088
Pharmaceutical form: Solution Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| riliprubart | Experimental | Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP) Receives: Drug: Riliprubart Prefilled Pen (PFP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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.
Measured: From first dose of riliprubart in parent study to end of treatment (up to approx. 7 years)
Percentage of participants experiencing improvement from baseline
Improvement is defined as a decrease of 1 point or more in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score relative to baseline of the current study, Study LTS17261
Measured: From Baseline to 3 years
Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time
Measured: From Baseline to 3 years
Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time
Measured: From Baseline to 3 years
Change from baseline in grip strength (kilopascals; dominant hand) over time
Measured: From Baseline to 3 years
Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time
Measured: From Baseline to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Apr 2025
- Primary completion3 Oct 2029 (estimated)
- Study completion3 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyneuropathy, Inflammatory Demyelinating, ChronicStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859099
- Sponsor's protocol ID
- LTS17261
- Other IDs
- U1111-1311-1432, 2024-517032-22-00
- Acronym
- LTS
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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