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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 63 sites in 24 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

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
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
63 sitesin 24 countries
Study dates
1 Apr 2025to 3 Oct 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

63 sites in 24 countries. Contact the study team or a site near you to ask about taking part.

63 sites in 24 countries

China11 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

  • Investigational Site Number : 1560004

    Xi'an, 710038

Other trials in China

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

Other trials in Italy

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

Other trials in Spain

United States5 sites

  • Alabama Neurology Associates- Site Number : 8400019

    Homewood, Alabama, 35209

  • University of Kansas Medical Center- Site Number : 8400010

    Kansas City, Kansas, 66160

  • Columbia University Irving Medical Center- Site Number : 8400003

    New York, New York, 10032

  • 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

Other trials in United States

France5 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 : 2500004

    Paris, 75013

Other trials in France

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

Other trials in Brazil

Germany3 sites

  • Investigational Site Number : 2760002

    Göttingen, 37075

  • Investigational Site Number : 2760003

    Münster, 48149

  • Investigational Site Number : 2760004

    Tübingen, 72076

Other trials in Germany

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

Other trials in Japan

Canada2 sites

  • Investigational Site Number : 1240001

    Gatineau, Quebec, J8Y 1W2

  • Investigational Site Number : 1240002

    Québec, Quebec, G1E 7G9

Other trials in Canada

Chile2 sites

  • Investigational Site Number : 1520003

    Lo Barnechea, Reg Metropolitana de Santiago, 7691236

  • Investigational Site Number : 1520002

    Puente Alto, Reg Metropolitana de Santiago, 8207257

Other trials in Chile

Czechia2 sites

  • Investigational Site Number : 2030004

    Brno, 625 00

  • Investigational Site Number : 2030001

    Prague, 128 08

Other trials in Czechia

Denmark2 sites

  • Investigational Site Number : 2080002

    Aarhus, 8200

  • Investigational Site Number : 2080001

    Copenhagen, 2100

Other trials in Denmark

Turkey (Türkiye)2 sites

  • Investigational Site Number : 7920001

    Istanbul, 34093

  • Investigational Site Number : 7920003

    Konya, 42075

Other trials in Turkey (Türkiye)

Argentina1 site

  • Investigational Site Number : 0320003

    Buenos Aires, 1221

Other trials in Argentina

Bulgaria1 site

  • Investigational Site Number : 1000002

    Blagoevgrad, 2700

Other trials in Bulgaria

Mexico1 site

  • Investigational Site Number : 4840001

    Tlalnepantla, 54055

Other trials in Mexico

Netherlands1 site

  • Investigational Site Number : 5280001

    Amsterdam, 1105 AZ

Other trials in Netherlands

Poland1 site

  • Investigational Site Number : 6160001

    Lublin, Lublin Voivodeship, 20-954

Other trials in Poland

Portugal1 site

  • Investigational Site Number : 6200004

    Lisbon, 1150-199

Other trials in Portugal

Serbia1 site

  • Investigational Site Number : 6880001

    Belgrade, 11000

Other trials in Serbia

South Korea1 site

  • Investigational Site Number : 4100003

    Seoul, Seoul-teukbyeolsi, 02841

Other trials in South Korea

Sweden1 site

  • Investigational Site Number : 7520001

    Stockholm, 113 65

Other trials in Sweden

Taiwan1 site

  • Investigational Site Number : 1580001

    Taipei, 100

Other trials in Taiwan

United Kingdom1 site

  • Investigational Site Number : 8260001

    Oxford, Oxfordshire, OX3 9DU

Other trials in United Kingdom

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 groups in NCT06859099
Study groupRoleWhat they receive
riliprubartExperimentalParticipants 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.

  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

    Measured: Up to End of Study (approx. 4 years)

Secondary outcomes (6)

  1. 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)

  2. 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

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

    Measured: From Baseline to 3 years

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

    Measured: From Baseline to 3 years

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

    Measured: From Baseline to 3 years

  6. 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.

  1. First posted5 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion3 Oct 2029 (estimated)
  4. Study completion3 Oct 2029 (estimated)

Resources

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)
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
Oct 2026
First submitted
27 Feb 2025
Last updated
27 Oct 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Riliprubart Prefilled Pen (PFP) in people with Polyneuropathy, Inflammatory Demyelinating, Chronic, run by Sanofi at 63 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in China, Italy, Spain, United States, France and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to End of Study (approx. 4 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06859099.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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