Recruiting
Phase 2
Phase 3

Nipocalimab

Sponsor:

Janssen Research & Development, LLC

Code:

NCT05327114

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nipocalimab

Placebo

Study Details

Brief summary:

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.

Conditions

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Study ID

NCT05327114

Start date

Sep 23, 2022

Status verified date

Aug, 2026

Completion date

Jul 11, 2028

Anticipated

Primary completion date

May 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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)
  • 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
  • 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
  • Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
  • Other protocol-defined exclusion criteria will apply

Study Design

Enrollment

201 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nipocalimab

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.

placebo comparator: Placebo

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.

Interventions

Nipocalimab

Nipocalimab will be administered intravenously.

Placebo

Placebo will be administered intravenously.

Primary outcome measure

  • Stage B: Time to First Occurrence of a Relapse Event [ Time Frame: Up to 52 weeks ]

Central Contacts and Locations

Central contacts

Study Contact

844-434-4210Participate-In-This-Study1@its.jnj.com

Locations

IMMUNOe Health and Research Centers

Recruiting

Centennial, Colorado, United States, 80112

Healthcare Innovations Institute Inc

Recruiting

Coral Springs, Florida, United States, 33067

ALS Center at the University of Miami

Recruiting

Miami, Florida, United States, 33136

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Johns Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21287

Kansas City Veterans Affairs Medical Center

Recruiting

Kansas City, Missouri, United States, 64128

South Shore Neurologic Associates - Patchogue

Recruiting

Patchogue, New York, United States, 11772

The Neurological Institute, PA

Recruiting

Charlotte, North Carolina, United States, 28204

Cleveland Clinic Main Campus

Recruiting

Cleveland, Ohio, United States, 44195

Austin Neuromuscular Center

Recruiting

Austin, Texas, United States, 78756

Advocate Health - Aurora St. Luke's Medical Center

Recruiting

Milwaukee, Wisconsin, United States, 53215

The Ottawa Hospital Ottawa NeuroMuscular Centre

Recruiting

Ottawa, Canada, K1N 6N5

More Information

Sponsor

Janssen Research & Development, LLC

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Janssen Research & Development, LLC on 2026-08-28.