Taking peoplePhase 2/3

Tests nipocalimab against placebo in adults with CIDP nerve disease

Tests nipocalimab against placebo in adults with CIDP, a nerve disorder.

Plain-language title generated from the registry record
Registry title: Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Key facts

Where: Kaohsiung City and Taipei, TaiwanSee the 3 sites
Phase: Phase 2/3

AI summary: who the study is looking for

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

Read by machine on 12 November 2026.

Where in Taiwan

Kaohsiung Chang Gung Memorial HospitalKaohsiung City, TaiwanNo longer taking part
National Taiwan University HospitalTaipei, TaiwanNo longer taking part
Shin Kong Wu Ho Su Memorial HospitalTaipei, TaiwanNo longer taking part

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 doctor

Trial details

Who runs it: Janssen Research & Development, LLC
Trial code: NCT05327114 EU 2023-508425-28-00
Record updated: 3 November 2026
Original description: 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.Read full original descriptionShow less
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)
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.
Inclusion: 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.
Exclusion: 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.
ClinicalTrials.gov NCT05327114 · EU CTIS 2023-508425-28-00