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Polyradiculoneuropathy, Chronic Inflammatory DemyelinatingPhase 2/3NCT05327114

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

A Phase 2/3 study testing Nipocalimab in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by Janssen Research & Development, LLC at 120 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Nipocalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
201 participants
Where
120 sitesin 19 countries
Study dates
23 Sep 2022to 11 Jul 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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

Trial locations and contacts

120 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Study Contact contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

120 sites in 19 countries

China19 sites

  • Peking University First Hospital

    Beijing, 100034

    Completed

  • Xuanwu Hospital ,Capital Medical University

    Beijing, 100053

    Active, not recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, 100070

    Active, not recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Completed

  • The First Hospital of Jilin University

    Changchun, 130021

    Active, not recruiting

  • The Third Xiangya Hospital of Central Sourth University

    Changsha, 410008

    Active, not recruiting

  • Xiangya Hospital Central South University

    Changsha, 410008

    Completed

  • Sichuan Provincial Peoples Hospital

    Chengdu, 610072

    Completed

  • Chifeng Municipal Hospital

    Chifeng, 024000

    Completed

  • Fujian Medical University Union Hospital

    Fuzhou, 350001

    Active, not recruiting

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080

    Active, not recruiting

  • Qilu Hospital of Shandong University

    Jinan, 250012

    Active, not recruiting

  • Qianfoshan hospital of Shandong Province

    Jinan, 250014

    Completed

  • The First Affiliated Hospital of NanChang University

    Nanchang, 330006

    Active, not recruiting

  • Huashan Hospital Fudan University

    Shanghai, 200040

    Active, not recruiting

  • Tong Ren Hospital Shanghai Jiao Tong University school of medicine

    Shanghai, 200336

    Completed

  • Renmin Hospital of Wuhan University

    Wuhan, 430023

    Completed

  • Tangdu hospital the Fourth Military Medical

    Xi'an, 710032

    Completed

  • Xi 'an GaoXin Hospital

    Xi'an, 710075

    Active, not recruiting

Other trials in China

Japan19 sites

  • National Hospital Organization Asahikawa Medical Center

    Asahikawa, 070-0901

    Active, not recruiting

  • Institute of Science Tokyo Hospital

    Bunkyō City, 113 8519

    Active, not recruiting

  • Chiba University Hospital

    Chiba, 260-8677

    Completed

  • Seirei Hamamatsu General Hospital

    Hamamatsu, 430-8558

    Active, not recruiting

  • Tokai University Hospital

    Isehara, 259-1193

    Active, not recruiting

  • Kobe City Medical Center General Hospital

    Kobe, 650 0047

    Completed

  • National Center of Neurology and Psychiatry

    Kodaira-shi, 187-8551

    Active, not recruiting

  • Saitama Medical Center

    Koshigaya, 343-8555

    Active, not recruiting

  • Kumamoto University Hospital

    Kumamoto, 860-8556

    Completed

  • Chubu Rosai Hospital

    Nagoya, 455-8530

    Active, not recruiting

  • Nagoya University Hospital

    Nagoya, 466-8560

    Active, not recruiting

  • Kindai University Hospital

    Osaka Sayama Shi, 589 8511

    Completed

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520

    Active, not recruiting

  • Dokkyo Medical University Hospital

    Shimotsuga Gun, 321 0293

    Completed

  • Tokyo Women's Medical University Hospital

    Shinjuku-ku, 162-8666

    Completed

  • Tenri Hospital

    Tenri, 632-0015

    Completed

  • Ehime University Hospital

    Toon-shi, 791-0295

    Completed

  • Toyama University Hospital

    Toyama, 930-0194

    Completed

  • Yamaguchi University Hospital

    Ube, 755-8505

    Completed

Other trials in Japan

United States16 sites

  • Augusta University

    Augusta, Georgia, 30912

    Completed

  • Austin Neuromuscular Center

    Austin, Texas, 78756

    Completed

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

    Completed

  • Boston Clinical Trials

    Boston, Massachusetts, 02111

    Completed

  • IMMUNOe Health and Research Centers

    Centennial, Colorado, 80112

    Active, not recruiting

  • The Neurological Institute, PA

    Charlotte, North Carolina, 28204

    Completed

  • Cleveland Clinic Main Campus

    Cleveland, Ohio, 44195

    Active, not recruiting

  • Healthcare Innovations Institute Inc

    Coral Springs, Florida, 33067

    Completed

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Completed

  • Kansas City Veterans Affairs Medical Center

    Kansas City, Missouri, 64128

    Completed

  • Neurology Associates PA

    Maitland, Florida, 32751

    Completed

  • ALS Center at the University of Miami

    Miami, Florida, 33136

    Active, not recruiting

  • Advocate Health - Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

    Active, not recruiting

  • The Neurological Institute of New York

    New York, New York, 10032

    Completed

  • South Shore Neurologic Associates - Patchogue

    Patchogue, New York, 11772

    Completed

  • Beaumont Hospital Royal Oak

    Royal Oak, Michigan, 48073

    Completed

Other trials in United States

France9 sites

  • CHU Bordeaux

    Bordeaux, 33000

    Completed

  • Hospices Civils de Lyon HCL

    Bron, 69699

    Completed

  • Hopital de Bicetre

    Le Kremlin-Bicêtre, 94270

    Active, not recruiting

  • Hopital de la Timone

    Marseille, 13385

    Active, not recruiting

  • Hopital PASTEUR

    Nice, 06000

    Active, not recruiting

  • CHU Nimes Hopital Caremeau

    Nîmes, 30029

    Active, not recruiting

  • Hopital de la Pitie Salpetriere

    Paris, 75013

    Completed

  • Fondation Adolphe de Rothschild Hospital

    Paris, 75019

    Completed

  • CHRU Strasbourg

    Strasbourg, 67200

    Active, not recruiting

Other trials in France

Italy9 sites

  • Azienda Ospedaliero-Universitaria Policlinico di Catania

    Catania, 95123

    Completed

  • Azienda Ospedaliera Universitaria San Martino di Genova

    Genova, 16132

    Completed

  • Casa di Cura del Policlinico

    Milan, 20144

    Completed

  • Istituto Neurologico Carlo Besta

    Milan, 20133

    Completed

  • Azienda Ospedaliera di Rilievo Nazionale A Cardarelli

    Naples, 80131

    Active, not recruiting

  • Aou San Luigi Gonzaga

    Orbassano, 10043

    Completed

  • Fondazione Istituto Neurologico Casimiro Mondino

    Pavia, 27100

    Completed

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    Roma, 00168

    Completed

  • IRCCS Istituto Clinico Humanitas

    Rozzano, 20086

    Completed

Other trials in Italy

Germany6 sites

  • Judisches Krankenhaus Berlin

    Berlin, 13347

    Active, not recruiting

  • St. Josef-Hospital, Ruhr-Universität Bochum

    Bochum, 44791

    Completed

  • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

    Halle, 6120

    Active, not recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Active, not recruiting

  • Universitaetsklinikum Leipzig

    Leipzig, 4103

    Completed

  • St Josefs Krankenhaus Potsdam Sanssouci

    Potsdam, 14471

    Completed

Other trials in Germany

Spain6 sites

  • Hosp. Gral. Univ. de Alicante

    Alicante, 03010

    Active, not recruiting

  • Hosp Univ Vall D Hebron

    Barcelona, 8035

    Completed

  • Hosp. Univ. de Basurto

    Bilbao, 48013

    Active, not recruiting

  • Hosp. Univ. Donostia

    Donostia / San Sebastian, 20014

    Completed

  • Hosp. Clinico San Carlos

    Madrid, 28040

    Completed

  • Hosp. Virgen Macarena

    Seville, 41009

    Active, not recruiting

Other trials in Spain

United Kingdom5 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

    Completed

  • Royal Devon & Exeter Hospital

    Devon, EX2 5DW

    Completed

  • NHS Greater Glasgow and Clyde

    Glasgow, G514TF

    Active, not recruiting

  • Royal Free Hospital

    London, NW3 2QG

    Completed

  • Sheffield Teaching Hospitals NHS Foundation Trust

    Sheffield, S10 2 JF

    Active, not recruiting

Other trials in United Kingdom

Argentina4 sites, 2 recruiting

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1199ABB

    Active, not recruiting

  • Instituto Fleni

    Buenos Aires, C1428AQK

    Recruiting

  • Hospital Gral Agudos Ignacio Pirovano

    Buenos Aires, C1428

    Completed

  • INECO Neurociencias Orono

    Rosario, 2900

    Recruiting

Other trials in Argentina

Greece4 sites, 2 recruiting

  • Papageorgiou General Hospital Of Thessaloniki

    Athens, 11527

    Completed

  • Attikon General Hospital of Athens

    Athens, 12462

    Recruiting

  • Patras University Hospital

    Pátrai, 26504

    Completed

  • Ahepa Hospital Aristotle University of Thessaloniki

    Thessaloniki, 54636

    Recruiting

Other trials in Greece

Poland4 sites

  • Centrum Medyczne

    Chorzów, 41 500

    Completed

  • Specjalistyczne Gabinety Lekarskie

    Krakow, 30 539

    Completed

  • Prywatny Gabinet Lekarski

    Lublin, 20 093

    Completed

  • Clinical Research Center sp z o o MEDIC R s k

    Poznan, 61 731

    Active, not recruiting

Other trials in Poland

Czechia3 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

    Active, not recruiting

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52

    Completed

  • Pardubicka krajska nemocnice a s

    Pardubice, 53203

    Completed

Other trials in Czechia

Portugal3 sites

  • Hospital Garcia de Orta

    Almada, 2805-267

    Active, not recruiting

  • Hospital de Braga

    Braga, 4710-243

    Completed

  • Centro Hospitalar de Sao Joao Epe

    Porto, 4200 319

    Active, not recruiting

Other trials in Portugal

South Korea3 sites

  • Kyunghee University Medical Center

    Seoul, 02447

    Completed

  • Konkuk University Medical Center

    Seoul, 05030

    Completed

  • Samsung Medical Center

    Seoul, 135-710

    Completed

Other trials in South Korea

Taiwan3 sites

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, 88301

    Completed

  • National Taiwan University Hospital

    Taipei, 100

    Active, not recruiting

  • Shin Kong Wu Ho Su Memorial Hospital

    Taipei, 111

    Active, not recruiting

Other trials in Taiwan

Australia2 sites

  • The Alfred Hospital

    Melbourne, 3004

    Completed

  • Gold Coast University Hospital

    Parkwood, 4215

    Completed

Other trials in Australia

Colombia2 sites

  • Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca

    Floridablanca, 681004

    Completed

  • Instituto Neurológico de Colombia

    Medellín, 50021

    Active, not recruiting

Other trials in Colombia

Mexico2 sites, 1 recruiting

  • i Can Oncology Center

    Monterrey, 64710

    Completed

  • Clinical Research Institute S.C.

    Tlalnepantla, 54055

    Recruiting

Other trials in Mexico

Canada1 site, 1 recruiting

  • The Ottawa Hospital Ottawa NeuroMuscular Centre

    Ottawa, K1N 6N5

    Recruiting

Other trials in Canada

About this study

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)

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.

Being tested
Nipocalimab, Placebo
Medical subject headings
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NipocalimabDrug

    Also called JNJ-80202135, M281

    Nipocalimab will be administered intravenously.

  • PlaceboDrug

    Placebo will be administered intravenously.

Study groups in NCT05327114
Study groupRoleWhat they receive
NipocalimabExperimentalParticipants 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.
Receives: Drug: Nipocalimab
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to 52 weeks

Secondary outcomes (29)

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

    Time to initial confirmed ECI will be reported.

    Measured: 12 weeks

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

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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).

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Stage A: 12 weeks; Stage B: Up to 52 weeks

  27. Titers of ADA to Nipocalimab

    Titers of ADA to nipocalimab will be reported.

    Measured: 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.

    Measured: 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.

    Measured: Stage A: Baseline to 12 weeks; Stage B: Baseline up to 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2022
  2. Study start23 Sep 2022
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion11 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
201 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05327114
Sponsor's protocol ID
CR109195
Other IDs
80202135CDP3001, 2021-003234-37, 2023-508425-28-00, 2023
Status last verified
Nov 2026
First submitted
7 Apr 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Nipocalimab in people with Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, run by Janssen Research & Development, LLC at 120 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in China, Japan, United States, France, Italy and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stage B: Time to First Occurrence of a Relapse Event (time frame: Up to 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05327114.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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