A Phase 3 interventional study of riliprubart and Placebo in Chronic Inflammatory Demyelinating Polyneuropathy, sponsored by Sanofi. Recruiting at 134 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Among 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States — 20 open to participants now, 25 under way, 10 of them phase 3. Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · United States.
Among the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States, this one is the 10th largest by planned enrollment of the 42 interventional ones that give a count, is one of 3 that started in 2024, is one of 15 in phase 3, reaches primary completion later than 8 of the 24 other live ones, and was the 36th 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 →20 of the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States are open now. Recruiting first, the newest first:
Kedrion S.p.A. · Sites in United States
Ages 18+
Kite, A Gilead Company · Sites in United States, Australia, Canada
Ages 18–75
Grifols Therapeutics LLC · Sites in United States, Czechia, Poland and 1 more country
Ages 18+
argenx · Sites in United States, Argentina, Austria and 22 more countries
Ages 18+
argenx · Sites in United States, Argentina, Australia and 28 more countries
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
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.
55 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 4 · Phase 2 17 · Phase 3 16 · Phase 4 2
First in 1990; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 160 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.
Median enrollment 74 across the 42 interventional studies, 120 across the 12 observational. Of the 28 that completed or were terminated, 14 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
39 of 55 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.
10 of the studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States that are under way reach primary completion within a year, 4 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 |
| NCT06920004Phase 3argenxA Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP | 2027-09 |
| NCT07091630Phase 3argenxA Study to Assess the Efficacy and Safety of Empasiprubart in Adults With CIDP | 2027-10-07 |
| NCT06680037TG Therapeutics, Inc.A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders | 2026-12-01 |
Add all 10 to your calendar (.ics) → With an account.
Among the 55 studies in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.
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:
Positive result of any of the following tests:
The above information is not intended to contain all considerations relevant to a participant'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.
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.
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
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.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Riliprubart + Placebo IVIg for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Drug: riliprubart · Drug: Placebo
IVIg (IVIg continuation) + Placebo riliprubart for 24 weeks followed by open-label extension phase with riliprubart for 24 weeks
Drug: Placebo · Drug: riliprubart · Drug: IVIg
Pharmaceutical form: Solution Route of administration: IV solution
Also known as: SAR445088
Pharmaceutical form: Solution Route of administration: IV solution
Pharmaceutical form: Solution Route of administration: SC solution
Also known as: SAR445088
Pharmaceutical form: Solution Route of administration: SC solution
Pharmaceutical form: Concentrate for solution for infusion (or any other formulation approved locally) Route of administration: IV solution
Pharmaceutical form: Placebo to match intravenous immunoglobulin IVIg for IV infusio Route of administration: IV solution
Percentage of participants experiencing a response
A response is defined as decrease of ≥1 point from baseline in adjusted INCAT disability score at Week 24
Time frame: Baseline to week 24
Percentage of participants randomized to riliprubart who responded during part A and had a lasting response during the open-label treatment extension period
Lasting response is defined as a decrease of ≥1 point in adjusted INCAT disability score
Time frame: Baseline to week 48
Change from baseline in Rasch-built Overall Disability Scale (I-RODS) score
Time frame: Baseline to week 24
Change from baseline in adjusted inflammatory neuropathy cause and treatment (INCAT) disability score
Time frame: Baseline to week 24
Change from baseline in grip strength (kilopascals, dominant hand)
Time frame: Baseline to week 24
Change from baseline in Medical Research Council Sum Score (MRC-SS)
Time frame: Baseline to week 24
Change from baseline in the Rasch-built modified fatigue severity scale (RT-FSS)
Time frame: Baseline to week 24
Percentage of participants experiencing a relapse
A relapse is defined as increase of ≥1 point from baseline in adjusted INCAT disability score
Time frame: Baseline to week 24
Change from baseline in the EuroQol 5 Dimension, 5-Level Health Scale (EQ-5D-5L)
Time frame: Baseline to week 24
Number of participants with TEAEs, including SAEs and AESIs for Part A
Time frame: Baseline to week 24
Number of participants with treatment-emergent ADA in participants treated with riliprubart
Time frame: Baseline to week 24
Number of participants with TEAEs, including SAEs and AESIs
Time frame: Week 24 to week 48
Incidence and titer of anti-drug antibodies (ADA) during open-label treatment and follow-up
Time frame: Baseline to week 109
Change from baseline in I-RODS
Time frame: Baseline to week 48
Change from baseline in adjusted INCAT score
Time frame: Baseline to week 48
Change from baseline in grip strength (kilopascals; dominant hand)
Time frame: Baseline to week 48
Change from baseline in MRC-SS
Time frame: Baseline to week 48
Change from baseline in EQ-5D-5L score
Time frame: Baseline to week 48
Percentage of participants randomized to IVIg continuation who experienced a response
A response is defined as a decrease of ≥1 point in adjusted INCAT disability scale score at Week 48 versus Week 24
Time frame: Week 24 to week 48
Percentage of participants randomized to riliprubart who experienced a response at Week 48 without prior response in Part A (delayed response)
A delayed response is defined as an decrease of ≥1 point in adjusted INCAT disability score at Week 48 versus Baseline
Time frame: Baseline to Week 48
Percentage of participants randomized to riliprubart experiencing a relapse
A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT disability score at Week 48 versus Baseline
Time frame: Baseline to week 48
Percentage of participants randomized to IVIg continuation experiencing a relapse
A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT disability score at Week 48 versus Week 24
Time frame: Week 24 to week 48
Change from baseline in RT-FSS
Time frame: Baseline to week 48
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Showing the first 100 of 134 sites across 24 countries. Choose a country and city above to see the rest.
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 Aug 2024 (actual). Primary completion is estimated for Jul 2027, 34 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.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Riliprubart
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating →