Tests nipocalimab against placebo in adults with CIDP nerve disease
Tests nipocalimab against placebo in adults with CIDP, a nerve disorder.
Key facts
- Who runs it
- Janssen Research & Development, LLC
- Where
- Asahikawa, Bunkyō City, Chiba, Hamamatsu, Isehara, Kobe, Kodaira-shi, Koshigaya, Kumamoto, Nagoya, Osaka Sayama Shi, Sendai, Shimotsuga-gun, Shinjuku-ku, Tenri, Toon-shi, Toyama, and Ube, JapanSee the 19 sitesAlso in 18 other countries, 100 sites
- Registry title
- Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Status
- Recruiting
- Phase
- Phase 2/3
- People taking part
- 201 people, planned
- Started
- 23 Sept 2022
- Expected to end
- 11 Jul 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Nipocalimab
- Placebo
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a long-lasting nerve disease, who still have active disease.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- CIDP in a progressing or relapsing form, confirmed by the 2021 EAN/PNS criteria and checked by an independent committee. Active disease (CDAS score 3 or more). Disability (INCAT) score between 2 and 9; a score of 2 must come only from the legs.
- Earlier treatment
- Can be on oral corticosteroids of 20 mg/day or less, or willing to lower a higher dose to that level. Can be on pulsed corticosteroids, IVIg or SCIg if willing to stop them by the run-in baseline visit. Can be treatment naive, or have stopped corticosteroids, IVIg or SCIg at least 3 months before screening.
Main reasons for not taking part
- Severe or uncontrolled liver, stomach and bowel, kidney, lung, heart, mental health, nerve or muscle disease, or other uncontrolled disease
- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP)
- Another disease that better explains the symptoms, such as stroke or central nervous system injury
- Nerve disease from another cause, such as multifocal motor neuropathy, hereditary neuropathy or diabetes
- Known allergy or intolerance to nipocalimab or its ingredients
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- Adults greater than or equal to (>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place
- Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period
- Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score
- Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (>) 20 mg/day and the participant is willing to taper to <=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
- Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3
- Other protocol-defined inclusion criteria will apply
Who cannot take part
- Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee
- Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
- Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results
- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
- Other protocol-defined exclusion criteria will apply
Where in Japan
Also in 18 other countries, 100 sites
- National Hospital Organization Asahikawa Medical CenterAsahikawa, JapanNo longer taking part
- Institute of Science Tokyo HospitalBunkyō City, JapanNo longer taking part
- Chiba University HospitalChiba, JapanNo longer taking part
- Seirei Hamamatsu General HospitalHamamatsu, JapanNo longer taking part
- Tokai University HospitalIsehara, JapanNo longer taking part
- Kobe City Medical Center General HospitalKobe, JapanNo longer taking part
- National Center of Neurology and PsychiatryKodaira-shi, JapanNo longer taking part
- Saitama Medical CenterKoshigaya, JapanNo longer taking part
- Kumamoto University HospitalKumamoto, JapanNo longer taking part
- Chubu Rosai HospitalNagoya, JapanNo longer taking part
- Nagoya University HospitalNagoya, JapanNo longer taking part
- Kindai University HospitalOsaka Sayama Shi, JapanNo longer taking part
- National Hospital Organization Sendai Medical CenterSendai, JapanNo longer taking part
- Dokkyo Medical University HospitalShimotsuga-gun, JapanNo longer taking part
- Tokyo Women's Medical University HospitalShinjuku-ku, JapanNo longer taking part
- Tenri HospitalTenri, JapanNo longer taking part
- Ehime University HospitalToon-shi, JapanNo longer taking part
- Toyama University HospitalToyama, JapanNo longer taking part
- Yamaguchi University HospitalUbe, JapanNo longer taking part
About the trial
What the trial wants to find out
The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.
The 2 groups in the trial
- NipocalimabTreatment being tested
Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
- PlaceboPlacebo, for comparison
Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Plain-language title
- Tests nipocalimab against placebo in adults with CIDP nerve diseaseGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026