A Phase 3 interventional study of Riliprubart Prefilled Pen (PFP) in Polyneuropathy, Inflammatory Demyelinating, Chronic, sponsored by Sanofi. Enrolling by invitation at 63 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Among 19 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in China — 13 open to participants now, 16 under way, 6 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · China.
Among the 19 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in China, this one is the 2nd largest by planned enrollment of the 16 interventional ones that give a count, is one of 8 that started in 2025, is one of 5 in phase 3, reaches primary completion later than 14 of the 15 other live ones, and was the 12th registered.
137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.
Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →13 of the 19 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in China are open now. Recruiting first, the newest first:
Tongji Hospital · Sites in China
Ages 18–75
Tongji Hospital · Sites in China
Ages 18–70
argenx · Sites in China, United States, Argentina and 22 more countries
Ages 18+
Tianjin Huanhu Hospital · Sites in China
Ages 18+
Tianjin Medical University General Hospital · Sites in China
Ages 18–60
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 36 Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies recruiting now, 24 (67%) set no upper age limit and 9 (25%) stop at 75 or younger; 4 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 5 · Phase 3 6
First in 2020; this study’s year is marked. 8 started in 2025.
This study's planned enrollment of 300 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 104 across the 16 interventional studies, 1,550 across the 3 observational. Of the 2 that completed or were terminated, 1 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
9 of 19 have an industry lead sponsor. The 10 most frequent:
Sanofi is the lead sponsor of 1,558 studies on the registry; 90 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Sanofi has 5 studies filed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating — fewer than ten, so there is no comparison to draw.
9 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in China that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05327114Phase 3Janssen Research & Development, LLCEfficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2026-12-15 |
| NCT06290141Phase 3SanofiA Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | 2027-07-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT07337785Tongji HospitalCD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases | 2026-12-01 |
| NCT06485232Xuanwu Hospital, BeijingUniversal CAR-T Cells in Patients with Refractory Autoimmune Diseases of the Nervous System. | 2026-12-31 |
Add all 9 to your calendar (.ics) → With an account.
Among the 19 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive subcutaneous injection with a riliprubart prefilled pen (PFP)
Drug: Riliprubart Prefilled Pen (PFP)
Pharmaceutical form: Solution Route of administration: Subcutaneous injection
Also known as: SAR445088
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
Time frame: Up to End of Study (approx. 4 years)
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.
Time frame: 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
Time frame: From Baseline to 3 years
Change from baseline in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score over time
Time frame: From Baseline to 3 years
Change from baseline in Inflammatory Rasch-built Overall Disability Scale (I-RODS) over time
Time frame: From Baseline to 3 years
Change from baseline in grip strength (kilopascals; dominant hand) over time
Time frame: From Baseline to 3 years
Change from baseline in Medical Research Council-Sum Score (MRC-SS) for muscle strength over time
Time frame: From Baseline to 3 years
Plan to share: 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
Started Apr 2025 (actual). Primary completion is estimated for Oct 2029, 54 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Riliprubart
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →