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RecruitingNCT05327114Updated Nov 3, 2026

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

A Phase 2/3 interventional study of Nipocalimab and Placebo in Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, sponsored by Janssen Research & Development, LLC. Recruiting at 120 sites in 19 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2022; still recruiting 4 years 1 month later.
Updated Nov 3, 2026Site recruiting status changedPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
201
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
03

In context

Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

137 studies on the registry are indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; 51 are open to participants now.

This study's planned enrollment of 201 is above the median of 37 across 85 interventional studies indexed under Polyradiculoneuropathy, Chronic Inflammatory Demyelinating.

Browse Polyradiculoneuropathy, Chronic Inflammatory Demyelinating studies →

Lead sponsor

Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.

Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.

Browse Janssen Research & Development, LLC studies →All Johnson & Johnson studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

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 (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

Exclusion Criteria:

  • Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/ 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 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, , or intolerance to nipocalimab or its
  • Other protocol-defined exclusion criteria will apply
Terms in these criteria, in plain language(5)

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.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
201 participants (estimated)

Study 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.

    Drug: Nipocalimab

  • 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.

    Drug: Placebo

Interventions

  • DrugNipocalimab

    Nipocalimab will be administered intravenously.

    Also known as: JNJ-80202135, M281

  • DrugPlacebo

    Placebo will be administered intravenously.

06

What researchers measure

Primary outcomes

  1. Stage B: Time to First Occurrence of a Relapse Event

    Stage B time to first occurrence of a relapse event will be reported.

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI)

    Time to initial confirmed ECI will be reported.

    Time frame: 12 weeks

  2. Stage A: Percentage of Responders as Determined by ECI

    Stage A percentage of responders as determined by ECI will be reported.

    Time frame: 12 weeks

  3. Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score

    Change from Stage A baseline over time in adjusted INCAT disability scale score will be reported. The INCAT disability scale is a clinician-rated assessment that measures activity limitation and degree of functional disability. The INCAT scale is an ordinal scale scored from 0 to 10, with higher scores indicating more disability.

    Time frame: Baseline to 12 weeks

  4. Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score

    Change from Stage A baseline over time in MRC muscle grading scale sum score will be reported. The MRC muscle grading scale is a clinician-rated outcome that provides a strength rating (on a scale from 0 \[no visible contraction\] to 5 \[normal\]) in 6 muscles collected bilaterally: deltoid, biceps, wrist extensors, iliopsoas, quadriceps, tibialis anterior. Lower scores indicate greater impairment.

    Time frame: Baseline to 12 weeks

  5. Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score

    Change from Stage A baseline over time in I-RODS centile score will be reported. The I-RODS comprises of 24 items representing common daily activities that address upper and lower limb disability and range in difficulty from very easy to very difficult. Lower scores indicate greater activity and social participation limitations.

    Time frame: Baseline to 12 weeks

  6. Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)

    Change from Stage A baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).

    Time frame: Baseline to 12 weeks

  7. Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)

    Change from Stage A baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).

    Time frame: Baseline to 12 weeks

  8. Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline

    Time to first adjusted INCAT disability scale score deterioration relative to Stage B baseline will be reported.

    Time frame: Up to 52 weeks

  9. Stage B: Time to First Switch to Intravenous Immunoglobulin (IVIg) or Other Standard of Care (SoC) as a Result of Investigator-assessed Lack of Efficacy as Confirmed by an Independent RAC Relative to Baseline

    Time to first switch to IVIg or other SoC as a result of investigator-assessed lack of efficacy as confirmed by an independent Relapse Adjudication Committee (RAC) relative to Stage B baseline will be reported.

    Time frame: Up to 52 weeks

  10. Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score

    Change from Stage B baseline over time in adjusted INCAT disability score will be reported.

    Time frame: Up to 52 weeks

  11. Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score

    Change from Stage B baseline over time in MRC Muscle Grading Scale Sum score will be reported.

    Time frame: Up to 52 weeks

  12. Stage B: Change from Baseline Over Time in I-RODS Centile Score

    Change from Stage B baseline over time in I-RODS centile score will be reported.

    Time frame: Up to 52 weeks

  13. Stage B: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand)

    Change from Stage B baseline over time in mean grip strength (dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).

    Time frame: Up to 52 weeks

  14. Stage B: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand)

    Change from Stage B baseline over time in mean grip strength (non-dominant hand) will be reported. Grip Strength is a quantifiable, objective performance outcome measure of hand strength, which can be measured using various devices (for example, Martin Vigorimeter and Jamar Dynamometer).

    Time frame: Up to 52 weeks

  15. Stage B: Number of Participants with Binary Response Endpoint Satisfying all 4 Conditions: a) An Improved Adjusted INCAT Disability Score Compared to Baseline; b) Not Relapsing; c) Not Switching to SoC; d) Not Discontinuing Treatment

    Number of participants with Binary response endpoint satisfying all 4 conditions: a) an improved adjusted INCAT Disability Score compared to Stage B baseline; b) not relapsing; c) not switching to SoC; d) not discontinuing treatment, will be reported.

    Time frame: Up to 52 weeks

  16. Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  17. Percentage of Participants with Serious Adverse Events (SAEs)

    SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  18. Number of Participants with Change in Electrocardiogram (ECG) Values Over Time

    Number of participants with change in ECG values over time will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  19. Number of Participants with Change in Vital Signs Values Over Time

    Number of participants with change in vital signs values over time will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  20. Number of Participants with Change in Clinical Laboratory Values Over Time

    Number of participants with change in clinical laboratory values over time will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  21. Number of Participants with Clinically Significant ECG Abnormalities

    Number of participants with clinically significant ECG abnormalities will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  22. Number of Participants with Clinically Significant Vital Signs Abnormalities

    Number of participants with clinically significant vital signs abnormalities will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  23. Number of Participants with Clinically Significant Clinical Laboratory Abnormalities

    Number of participants with clinically significant clinical laboratory abnormalities will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  24. Percentage of Participants with Suicidal Ideation or Suicidal Behavior based on the Columbia-Suicide Severity Rating Scale (C-SSRS)

    Percentage of participants with suicidal ideation or suicidal behavior based on the C-SSRS will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  25. Serum Nipocalimab Concentrations Over Time in Participants Receiving Active Study Intervention

    Serum nipocalimab concentrations over time in participants receiving active study intervention will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  26. Number of Participants with Anti-drug Antibodies (ADA) to Nipocalimab

    Number of participants with ADA to Nipocalimab will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  27. Titers of ADA to Nipocalimab

    Titers of ADA to nipocalimab will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  28. Number of Participants with Neutralizing Antibodies (NAb) to Nipocalimab

    Number of participants with NAb to Nipocalimab will be reported.

    Time frame: Stage A: 12 weeks; Stage B: Up to 52 weeks

  29. Change from Baseline in Total Serum Immunoglobulin (IgG) Concentrations Levels Over Time

    Change from baseline in total serum IgG concentrations levels over time will be reported.

    Time frame: Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks

07

Study locations

6 of 120 sites recruiting
  • IMMUNOe Health and Research Centers
    Centennial, Colorado 80112, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Healthcare Innovations Institute Inc
    Coral Springs, Florida 33067, United States
    Completed

    Not enrolling at this site — choose another above.

  • Neurology Associates PA
    Maitland, Florida 32751, United States
    Completed

    Not enrolling at this site — choose another above.

  • ALS Center at the University of Miami
    Miami, Florida 33136, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Augusta University
    Augusta, Georgia 30912, United States
    Completed

    Not enrolling at this site — choose another above.

  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    Completed

    Not enrolling at this site — choose another above.

  • Johns Hopkins Hospital
    Baltimore, Maryland 21287, United States
    Completed

    Not enrolling at this site — choose another above.

  • Boston Clinical Trials
    Boston, Massachusetts 02111, United States
    Completed

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  • Beaumont Hospital Royal Oak
    Royal Oak, Michigan 48073, United States
    Completed

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  • Kansas City Veterans Affairs Medical Center
    Kansas City, Missouri 64128, United States
    Completed

    Not enrolling at this site — choose another above.

  • The Neurological Institute of New York
    New York, New York 10032, United States
    Completed

    Not enrolling at this site — choose another above.

  • South Shore Neurologic Associates - Patchogue
    Patchogue, New York 11772, United States
    Completed

    Not enrolling at this site — choose another above.

  • The Neurological Institute, PA
    Charlotte, North Carolina 28204, United States
    Completed

    Not enrolling at this site — choose another above.

  • Cleveland Clinic Main Campus
    Cleveland, Ohio 44195, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Austin Neuromuscular Center
    Austin, Texas 78756, United States
    Completed

    Not enrolling at this site — choose another above.

  • Advocate Health - Aurora St. Luke's Medical Center
    Milwaukee, Wisconsin 53215, United States
    Active, not recruiting

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  • Hospital Italiano de Buenos Aires
    Buenos Aires, C1199ABB, Argentina
    Active, not recruiting

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  • Instituto Fleni
    Buenos Aires, C1428AQK, Argentina
    Recruiting
  • Hospital Gral Agudos Ignacio Pirovano
    Buenos Aires, C1428, Argentina
    Completed

    Not enrolling at this site — choose another above.

  • INECO Neurociencias Orono
    Rosario, 2900, Argentina
    Recruiting
  • The Alfred Hospital
    Melbourne, 3004, Australia
    Completed

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  • Gold Coast University Hospital
    Parkwood, 4215, Australia
    Completed

    Not enrolling at this site — choose another above.

  • The Ottawa Hospital Ottawa NeuroMuscular Centre
    Ottawa, K1N 6N5, Canada
    Recruiting
  • Peking University First Hospital
    Beijing, 100034, China
    Completed

    Not enrolling at this site — choose another above.

  • Xuanwu Hospital ,Capital Medical University
    Beijing, 100053, China
    Active, not recruiting

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  • Beijing Tiantan Hospital, Capital Medical University
    Beijing, 100070, China
    Active, not recruiting

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  • Peking University Third Hospital
    Beijing, 100191, China
    Completed

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  • The First Hospital of Jilin University
    Changchun, 130021, China
    Active, not recruiting

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  • The Third Xiangya Hospital of Central Sourth University
    Changsha, 410008, China
    Active, not recruiting

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  • Xiangya Hospital Central South University
    Changsha, 410008, China
    Completed

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  • Sichuan Provincial Peoples Hospital
    Chengdu, 610072, China
    Completed

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  • Chifeng Municipal Hospital
    Chifeng, 024000, China
    Completed

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  • Fujian Medical University Union Hospital
    Fuzhou, 350001, China
    Active, not recruiting

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  • The First Affiliated Hospital Sun Yat sen University
    Guangzhou, 510080, China
    Active, not recruiting

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  • Qilu Hospital of Shandong University
    Jinan, 250012, China
    Active, not recruiting

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  • Qianfoshan hospital of Shandong Province
    Jinan, 250014, China
    Completed

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  • The First Affiliated Hospital of NanChang University
    Nanchang, 330006, China
    Active, not recruiting

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  • Huashan Hospital Fudan University
    Shanghai, 200040, China
    Active, not recruiting

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  • Tong Ren Hospital Shanghai Jiao Tong University school of medicine
    Shanghai, 200336, China
    Completed

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  • Renmin Hospital of Wuhan University
    Wuhan, 430023, China
    Completed

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  • Tangdu hospital the Fourth Military Medical
    Xi'an, 710032, China
    Completed

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  • Xi 'an GaoXin Hospital
    Xi'an, 710075, China
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca
    Floridablanca, 681004, Colombia
    Completed

    Not enrolling at this site — choose another above.

  • Instituto Neurológico de Colombia
    Medellín, 50021, Colombia
    Active, not recruiting

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  • Fakultni nemocnice Hradec Kralove
    Hradec Králové, 500 05, Czechia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Fakultni Nemocnice Ostrava
    Ostrava, 708 52, Czechia
    Completed

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  • Pardubicka krajska nemocnice a s
    Pardubice, 53203, Czechia
    Completed

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  • CHU Bordeaux
    Bordeaux, 33000, France
    Completed

    Not enrolling at this site — choose another above.

  • Hospices Civils de Lyon HCL
    Bron, 69699, France
    Completed

    Not enrolling at this site — choose another above.

  • Hopital de Bicetre
    Le Kremlin-Bicêtre, 94270, France
    Active, not recruiting

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  • Hopital de la Timone
    Marseille, 13385, France
    Active, not recruiting

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  • Hopital PASTEUR
    Nice, 06000, France
    Active, not recruiting

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  • CHU Nimes Hopital Caremeau
    Nîmes, 30029, France
    Active, not recruiting

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  • Hopital de la Pitie Salpetriere
    Paris, 75013, France
    Completed

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  • Fondation Adolphe de Rothschild Hospital
    Paris, 75019, France
    Completed

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  • CHRU Strasbourg
    Strasbourg, 67200, France
    Active, not recruiting

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  • Judisches Krankenhaus Berlin
    Berlin, 13347, Germany
    Active, not recruiting

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  • St. Josef-Hospital, Ruhr-Universität Bochum
    Bochum, 44791, Germany
    Completed

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  • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
    Halle, 6120, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Medizinische Hochschule Hannover
    Hanover, 30625, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitaetsklinikum Leipzig
    Leipzig, 4103, Germany
    Completed

    Not enrolling at this site — choose another above.

  • St Josefs Krankenhaus Potsdam Sanssouci
    Potsdam, 14471, Germany
    Completed

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  • Papageorgiou General Hospital Of Thessaloniki
    Athens, 11527, Greece
    Completed

    Not enrolling at this site — choose another above.

  • Attikon General Hospital of Athens
    Athens, 12462, Greece
    Recruiting
  • Patras University Hospital
    Pátrai, 26504, Greece
    Completed

    Not enrolling at this site — choose another above.

  • Ahepa Hospital Aristotle University of Thessaloniki
    Thessaloniki, 54636, Greece
    Recruiting
  • Azienda Ospedaliero-Universitaria Policlinico di Catania
    Catania, 95123, Italy
    Completed

    Not enrolling at this site — choose another above.

  • Azienda Ospedaliera Universitaria San Martino di Genova
    Genova, 16132, Italy
    Completed

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  • Casa di Cura del Policlinico
    Milan, 20144, Italy
    Completed

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  • Istituto Neurologico Carlo Besta
    Milan, 20133, Italy
    Completed

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  • Azienda Ospedaliera di Rilievo Nazionale A Cardarelli
    Naples, 80131, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Aou San Luigi Gonzaga
    Orbassano, 10043, Italy
    Completed

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  • Fondazione Istituto Neurologico Casimiro Mondino
    Pavia, 27100, Italy
    Completed

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  • Fondazione Policlinico Universitario A Gemelli IRCCS
    Roma, 00168, Italy
    Completed

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  • IRCCS Istituto Clinico Humanitas
    Rozzano, 20086, Italy
    Completed

    Not enrolling at this site — choose another above.

  • National Hospital Organization Asahikawa Medical Center
    Asahikawa, 070-0901, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Institute of Science Tokyo Hospital
    Bunkyō City, 113 8519, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Chiba University Hospital
    Chiba, 260-8677, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Seirei Hamamatsu General Hospital
    Hamamatsu, 430-8558, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Tokai University Hospital
    Isehara, 259-1193, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kobe City Medical Center General Hospital
    Kobe, 650 0047, Japan
    Completed

    Not enrolling at this site — choose another above.

  • National Center of Neurology and Psychiatry
    Kodaira-shi, 187-8551, Japan
    Active, not recruiting

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  • Saitama Medical Center
    Koshigaya, 343-8555, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kumamoto University Hospital
    Kumamoto, 860-8556, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Chubu Rosai Hospital
    Nagoya, 455-8530, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Nagoya University Hospital
    Nagoya, 466-8560, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kindai University Hospital
    Osaka Sayama Shi, 589 8511, Japan
    Completed

    Not enrolling at this site — choose another above.

  • National Hospital Organization Sendai Medical Center
    Sendai, 983-8520, Japan
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dokkyo Medical University Hospital
    Shimotsuga Gun, 321 0293, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Tokyo Women's Medical University Hospital
    Shinjuku-ku, 162-8666, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Tenri Hospital
    Tenri, 632-0015, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Ehime University Hospital
    Toon-shi, 791-0295, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Toyama University Hospital
    Toyama, 930-0194, Japan
    Completed

    Not enrolling at this site — choose another above.

  • Yamaguchi University Hospital
    Ube, 755-8505, Japan
    Completed

    Not enrolling at this site — choose another above.

  • i Can Oncology Center
    Monterrey, 64710, Mexico
    Completed

    Not enrolling at this site — choose another above.

  • Clinical Research Institute S.C.
    Tlalnepantla, 54055, Mexico
    Recruiting
  • Centrum Medyczne
    Chorzów, 41 500, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Specjalistyczne Gabinety Lekarskie
    Krakow, 30 539, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Prywatny Gabinet Lekarski
    Lublin, 20 093, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Clinical Research Center sp z o o MEDIC R s k
    Poznan, 61 731, Poland
    Active, not recruiting

    Not enrolling at this site — choose another above.

Showing the first 100 of 120 sites across 19 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: Yes — The data sharing policy of Johnson \& Johnson Innovative Medicine is available at www.innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Data sharing details ↗ · innovativemedicine.jnj.com

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Sites
1 site added, 1 site removed. 95 sites changed recruiting status (50 now completed, 45 now active, not recruiting)
Show 95 sites
  • St Josefs Krankenhaus Potsdam Sanssouci · Potsdam, GermanyRecruiting→Completed
  • IMMUNOe Health and Research Centers · Centennial, United StatesRecruiting→Active, not recruiting
  • Healthcare Innovations Institute Inc · Coral Springs, United StatesRecruiting→Completed
  • ALS Center at the University of Miami · Miami, United StatesRecruiting→Active, not recruiting
  • Augusta University · Augusta, United StatesRecruiting→Completed
  • University of Kansas Medical Center · Kansas City, United StatesRecruiting→Completed
  • Johns Hopkins Hospital · Baltimore, United StatesRecruiting→Completed
  • Kansas City Veterans Affairs Medical Center · Kansas City, United StatesRecruiting→Completed
  • South Shore Neurologic Associates - Patchogue · Patchogue, United StatesRecruiting→Completed
  • The Neurological Institute, PA · Charlotte, United StatesRecruiting→Completed
  • Cleveland Clinic Main Campus · Cleveland, United StatesRecruiting→Active, not recruiting
  • Austin Neuromuscular Center · Austin, United StatesRecruiting→Completed
  • Advocate Health - Aurora St. Luke's Medical Center · Milwaukee, United StatesRecruiting→Active, not recruiting
  • Hospital Italiano de Buenos Aires · Buenos Aires, ArgentinaRecruiting→Active, not recruiting
  • Hospital Gral Agudos Ignacio Pirovano · Buenos Aires, ArgentinaRecruiting→Completed
  • Peking University First Hospital · Beijing, ChinaRecruiting→Completed
  • Xuanwu Hospital ,Capital Medical University · Beijing, ChinaRecruiting→Active, not recruiting
  • Beijing Tiantan Hospital, Capital Medical University · Beijing, ChinaRecruiting→Active, not recruiting
  • Peking University Third Hospital · Beijing, ChinaRecruiting→Completed
  • The First Hospital of Jilin University · Changchun, ChinaRecruiting→Active, not recruiting
  • The Third Xiangya Hospital of Central Sourth University · Changsha, ChinaRecruiting→Active, not recruiting
  • Xiangya Hospital Central South University · Changsha, ChinaRecruiting→Completed
  • Sichuan Provincial Peoples Hospital · Chengdu, ChinaRecruiting→Completed
  • Chifeng Municipal Hospital · Chifeng, ChinaRecruiting→Completed
  • Fujian Medical University Union Hospital · Fuzhou, ChinaRecruiting→Active, not recruiting
  • The First Affiliated Hospital Sun Yat sen University · Guangzhou, ChinaRecruiting→Active, not recruiting
  • Qilu Hospital of Shandong University · Jinan, ChinaRecruiting→Active, not recruiting
  • The First Affiliated Hospital of NanChang University · Nanchang, ChinaRecruiting→Active, not recruiting
  • Huashan Hospital Fudan University · Shanghai, ChinaRecruiting→Active, not recruiting
  • Renmin Hospital of Wuhan University · Wuhan, ChinaRecruiting→Completed
  • …and 65 more on the registry record
Show site
  • Papageorgiou General Hospital Of Thessaloniki · Athens, Greece
Show 1 removed
  • Papageorgiou General Hospital Of Thessaloniki · Thessaloniki, Greece
across 2 updates, Sep 25, 2026 – Nov 3, 2026
Primary completion
May 14, 2027→Dec 15, 2026
Nov 3, 2026
Study completion
Changed, then back to Jul 11, 2028
moved 2 times, Sep 25, 2026 – Nov 3, 2026
Show all 2 updates
  1. Nov 3, 2026
    1 site added, 1 site removed. 94 sites changed recruiting status (49 now completed, 45 now active, not recruiting)
    Show 94 sites
    • IMMUNOe Health and Research Centers · Centennial, United StatesRecruiting→Active, not recruiting
    • Healthcare Innovations Institute Inc · Coral Springs, United StatesRecruiting→Completed
    • ALS Center at the University of Miami · Miami, United StatesRecruiting→Active, not recruiting
    • Augusta University · Augusta, United StatesRecruiting→Completed
    • University of Kansas Medical Center · Kansas City, United StatesRecruiting→Completed
    • Johns Hopkins Hospital · Baltimore, United StatesRecruiting→Completed
    • Kansas City Veterans Affairs Medical Center · Kansas City, United StatesRecruiting→Completed
    • South Shore Neurologic Associates - Patchogue · Patchogue, United StatesRecruiting→Completed
    • The Neurological Institute, PA · Charlotte, United StatesRecruiting→Completed
    • Cleveland Clinic Main Campus · Cleveland, United StatesRecruiting→Active, not recruiting
    • Austin Neuromuscular Center · Austin, United StatesRecruiting→Completed
    • Advocate Health - Aurora St. Luke's Medical Center · Milwaukee, United StatesRecruiting→Active, not recruiting
    • Hospital Italiano de Buenos Aires · Buenos Aires, ArgentinaRecruiting→Active, not recruiting
    • Hospital Gral Agudos Ignacio Pirovano · Buenos Aires, ArgentinaRecruiting→Completed
    • Peking University First Hospital · Beijing, ChinaRecruiting→Completed
    • Xuanwu Hospital ,Capital Medical University · Beijing, ChinaRecruiting→Active, not recruiting
    • Beijing Tiantan Hospital, Capital Medical University · Beijing, ChinaRecruiting→Active, not recruiting
    • Peking University Third Hospital · Beijing, ChinaRecruiting→Completed
    • The First Hospital of Jilin University · Changchun, ChinaRecruiting→Active, not recruiting
    • The Third Xiangya Hospital of Central Sourth University · Changsha, ChinaRecruiting→Active, not recruiting
    • Xiangya Hospital Central South University · Changsha, ChinaRecruiting→Completed
    • Sichuan Provincial Peoples Hospital · Chengdu, ChinaRecruiting→Completed
    • Chifeng Municipal Hospital · Chifeng, ChinaRecruiting→Completed
    • Fujian Medical University Union Hospital · Fuzhou, ChinaRecruiting→Active, not recruiting
    • The First Affiliated Hospital Sun Yat sen University · Guangzhou, ChinaRecruiting→Active, not recruiting
    • Qilu Hospital of Shandong University · Jinan, ChinaRecruiting→Active, not recruiting
    • The First Affiliated Hospital of NanChang University · Nanchang, ChinaRecruiting→Active, not recruiting
    • Huashan Hospital Fudan University · Shanghai, ChinaRecruiting→Active, not recruiting
    • Renmin Hospital of Wuhan University · Wuhan, ChinaRecruiting→Completed
    • Tangdu hospital the Fourth Military Medical · Xi'an, ChinaRecruiting→Completed
    • …and 64 more on the registry record
    Show site
    • Papageorgiou General Hospital Of Thessaloniki · Athens, Greece
    Show 1 removed
    • Papageorgiou General Hospital Of Thessaloniki · Thessaloniki, Greece
    Primary completion May 14, 2027→Dec 15, 2026
    Study completion Nov 27, 2028→Jul 11, 2028
    + 1 other change: verification date
  2. Sep 25, 2026
    St Josefs Krankenhaus Potsdam Sanssouci is now Completed
    Study completion Jul 11, 2028→Nov 27, 2028
    + 1 other change: verification date

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 ↗

10

Registry details

Key details

Study ID
NCT05327114
Lead sponsor
Janssen Research & Development, LLC
Responsible party
Sponsor
First posted
Apr 14, 2022
Start date
Sep 23, 2022
Primary completion
Dec 15, 2026 (estimated)
Completion
Jul 11, 2028 (estimated)
Last update
Nov 3, 2026

Study contacts

Study Contact
Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Janssen Research & Development, LLC Clinical Trial
study director · Janssen Research & Development, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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