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New drug shows promise in keeping CIDP relapses at bay

NCT ID NCT05327114

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests whether the drug nipocalimab can delay or prevent relapses in adults with CIDP, a rare nerve disorder that causes weakness and numbness. Participants first receive nipocalimab, and those who improve are then randomly assigned to continue the drug or switch to a placebo. The goal is to see if nipocalimab keeps the disease under control better than no treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 201 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2022

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

chronic inflammatory demyelinating polyradiculoneuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Polyradiculoneuropathy, chronic inflammatory demyelinating

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    102 sites in 18 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ALS Center at the University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

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

    RECRUITING

    Milwaukee, Wisconsin, 53215, United States

  • Ahepa Hospital Aristotle University of Thessaloniki

    RECRUITING

    Thessaloniki, 54636, Greece

  • Aou San Luigi Gonzaga

    RECRUITING

    Orbassano, 10043, Italy

  • Attikon General Hospital of Athens

    RECRUITING

    Athens, 12462, Greece

  • Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Austin Neuromuscular Center

    RECRUITING

    Austin, Texas, 78756, United States

  • Azienda Ospedaliera Universitaria San Martino di Genova

    RECRUITING

    Genova, 16132, Italy

  • Azienda Ospedaliera di Rilievo Nazionale A Cardarelli

    RECRUITING

    Naples, 80131, Italy

  • Azienda Ospedaliero-Universitaria Policlinico di Catania

    RECRUITING

    Catania, 95123, Italy

  • Beaumont Hospital Royal Oak

    COMPLETED

    Royal Oak, Michigan, 48073, United States

  • Beijing Tiantan Hospital, Capital Medical University

    RECRUITING

    Beijing, 100070, China

  • Boston Clinical Trials

    COMPLETED

    Boston, Massachusetts, 02111, United States

  • CHRU Strasbourg

    RECRUITING

    Strasbourg, 67200, France

  • CHU Bordeaux

    RECRUITING

    Bordeaux, 33000, France

  • CHU Nimes Hopital Caremeau

    RECRUITING

    Nîmes, 30029, France

  • Casa di Cura del Policlinico

    RECRUITING

    Milan, 20144, Italy

  • Centro Hospitalar de Sao Joao Epe

    RECRUITING

    Porto, 4200 319, Portugal

  • Centrum Medyczne

    COMPLETED

    Chorzów, 41 500, Poland

  • Chiba University Hospital

    RECRUITING

    Chiba, 260-8677, Japan

  • Chifeng Municipal Hospital

    RECRUITING

    Chifeng, 024000, China

  • Chubu Rosai Hospital

    RECRUITING

    Nagoya, 455-8530, Japan

  • Cleveland Clinic Main Campus

    RECRUITING

    Cleveland, Ohio, 44195, United States

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

    RECRUITING

    Poznan, 61 731, Poland

  • Clinical Research Institute S.C.

    RECRUITING

    Tlalnepantla, 54055, Mexico

  • Dokkyo Medical University Hospital

    COMPLETED

    Shimotsuga Gun, 321 0293, Japan

  • Ehime University Hospital

    RECRUITING

    Toon-shi, 791-0295, Japan

  • Fakultni Nemocnice Ostrava

    COMPLETED

    Ostrava, 708 52, Czechia

  • Fakultni nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, 500 05, Czechia

  • Fondation Adolphe de Rothschild Hospital

    RECRUITING

    Paris, 75019, France

  • Fondazione Istituto Neurologico Casimiro Mondino

    RECRUITING

    Pavia, 27100, Italy

  • Fondazione Policlinico Universitario A Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, 350001, China

  • Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca

    RECRUITING

    Floridablanca, 681004, Colombia

  • Gold Coast University Hospital

    COMPLETED

    Parkwood, 4215, Australia

  • Healthcare Innovations Institute Inc

    RECRUITING

    Coral Springs, Florida, 33067, United States

  • Hopital PASTEUR

    RECRUITING

    Nice, 06000, France

  • Hopital de Bicetre

    RECRUITING

    Le Kremlin-Bicêtre, 94270, France

  • Hopital de la Pitie Salpetriere

    RECRUITING

    Paris, 75013, France

  • Hopital de la Timone

    RECRUITING

    Marseille, 13385, France

  • Hosp Univ Vall D Hebron

    RECRUITING

    Barcelona, 8035, Spain

  • Hosp. Clinico San Carlos

    RECRUITING

    Madrid, 28040, Spain

  • Hosp. Gral. Univ. de Alicante

    RECRUITING

    Alicante, 03010, Spain

  • Hosp. Univ. Donostia

    RECRUITING

    Donostia / San Sebastian, 20014, Spain

  • Hosp. Univ. de Basurto

    RECRUITING

    Bilbao, 48013, Spain

  • Hosp. Virgen Macarena

    RECRUITING

    Seville, 41009, Spain

  • Hospices Civils de Lyon HCL

    RECRUITING

    Bron, 69699, France

  • Hospital Garcia de Orta

    RECRUITING

    Almada, 2805-267, Portugal

  • Hospital Gral Agudos Ignacio Pirovano

    RECRUITING

    Buenos Aires, C1428, Argentina

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Buenos Aires, C1199ABB, Argentina

  • Hospital de Braga

    RECRUITING

    Braga, 4710-243, Portugal

  • Huashan Hospital Fudan University

    RECRUITING

    Shanghai, 200040, China

  • IMMUNOe Health and Research Centers

    RECRUITING

    Centennial, Colorado, 80112, United States

  • INECO Neurociencias Orono

    RECRUITING

    Rosario, 2900, Argentina

  • IRCCS Istituto Clinico Humanitas

    RECRUITING

    Rozzano, 20086, Italy

  • Institute of Science Tokyo Hospital

    RECRUITING

    Bunkyō City, 113 8519, Japan

  • Instituto Fleni

    RECRUITING

    Buenos Aires, C1428AQK, Argentina

  • Instituto Neurológico de Colombia

    RECRUITING

    Medellín, 50021, Colombia

  • Istituto Neurologico Carlo Besta

    RECRUITING

    Milan, 20133, Italy

  • Johns Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Judisches Krankenhaus Berlin

    RECRUITING

    Berlin, 13347, Germany

  • Kansas City Veterans Affairs Medical Center

    RECRUITING

    Kansas City, Missouri, 64128, United States

  • Kaohsiung Chang Gung Memorial Hospital

    COMPLETED

    Kaohsiung City, 88301, Taiwan

  • Kindai University Hospital

    RECRUITING

    Osaka Sayama Shi, 589 8511, Japan

  • Kobe City Medical Center General Hospital

    COMPLETED

    Kobe, 650 0047, Japan

  • Konkuk University Medical Center

    COMPLETED

    Seoul, 05030, South Korea

  • Kumamoto University Hospital

    RECRUITING

    Kumamoto, 860-8556, Japan

  • Kyunghee University Medical Center

    RECRUITING

    Seoul, 02447, South Korea

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • NHS Greater Glasgow and Clyde

    RECRUITING

    Glasgow, G514TF, United Kingdom

  • Nagoya University Hospital

    RECRUITING

    Nagoya, 466-8560, Japan

  • National Center of Neurology and Psychiatry

    RECRUITING

    Kodaira-shi, 187-8551, Japan

  • National Hospital Organization Asahikawa Medical Center

    RECRUITING

    Asahikawa, 070-0901, Japan

  • National Hospital Organization Sendai Medical Center

    RECRUITING

    Sendai, 983-8520, Japan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • Neurology Associates PA

    COMPLETED

    Maitland, Florida, 32751, United States

  • Papageorgiou General Hospital Of Thessaloniki

    RECRUITING

    Thessaloniki, 56429, Greece

  • Pardubicka krajska nemocnice a s

    COMPLETED

    Pardubice, 53203, Czechia

  • Patras University Hospital

    COMPLETED

    Pátrai, 26504, Greece

  • Peking University First Hospital

    RECRUITING

    Beijing, 100034, China

  • Peking University Third Hospital

    RECRUITING

    Beijing, 100191, China

  • Prywatny Gabinet Lekarski

    RECRUITING

    Lublin, 20 093, Poland

  • Qianfoshan hospital of Shandong Province

    COMPLETED

    Jinan, 250014, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, 250012, China

  • Renmin Hospital of Wuhan University

    RECRUITING

    Wuhan, 430023, China

  • Royal Devon & Exeter Hospital

    RECRUITING

    Devon, EX2 5DW, United Kingdom

  • Royal Free Hospital

    SUSPENDED

    London, NW3 2QG, United Kingdom

  • Saitama Medical Center

    RECRUITING

    Koshigaya, 343-8555, Japan

  • Samsung Medical Center

    RECRUITING

    Seoul, 135-710, South Korea

  • Seirei Hamamatsu General Hospital

    RECRUITING

    Hamamatsu, 430-8558, Japan

  • Sheffield Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Sheffield, S10 2 JF, United Kingdom

  • Shin Kong Wu Ho Su Memorial Hospital

    RECRUITING

    Taipei, 111, Taiwan

  • Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, 610072, China

  • South Shore Neurologic Associates - Patchogue

    RECRUITING

    Patchogue, New York, 11772, United States

  • Specjalistyczne Gabinety Lekarskie

    COMPLETED

    Krakow, 30 539, Poland

  • St Josefs Krankenhaus Potsdam Sanssouci

    RECRUITING

    Potsdam, 14471, Germany

  • St. Josef-Hospital, Ruhr-Universität Bochum

    RECRUITING

    Bochum, 44791, Germany

  • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH

    RECRUITING

    Halle, 6120, Germany

  • Tangdu hospital the Fourth Military Medical

    RECRUITING

    Xi'an, 710032, China

  • Tenri Hospital

    RECRUITING

    Tenri, 632-0015, Japan

  • The Alfred Hospital

    COMPLETED

    Melbourne, 3004, Australia

  • The First Affiliated Hospital Sun Yat sen University

    RECRUITING

    Guangzhou, 510080, China

  • The First Affiliated Hospital of NanChang University

    RECRUITING

    Nanchang, 330006, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, 130021, China

  • The Neurological Institute of New York

    COMPLETED

    New York, New York, 10032, United States

  • The Neurological Institute, PA

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • The Ottawa Hospital Ottawa NeuroMuscular Centre

    RECRUITING

    Ottawa, K1N 6N5, Canada

  • The Third Xiangya Hospital of Central Sourth University

    RECRUITING

    Changsha, 410008, China

  • Tokai University Hospital

    RECRUITING

    Isehara, 259-1193, Japan

  • Tokyo Women's Medical University Hospital

    COMPLETED

    Shinjuku-ku, 162-8666, Japan

  • Tong Ren Hospital Shanghai Jiao Tong University school of medicine

    COMPLETED

    Shanghai, 200336, China

  • Toyama University Hospital

    RECRUITING

    Toyama, 930-0194, Japan

  • Universitaetsklinikum Leipzig

    RECRUITING

    Leipzig, 4103, Germany

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Xi 'an GaoXin Hospital

    RECRUITING

    Xi'an, 710075, China

  • Xiangya Hospital Central South University

    RECRUITING

    Changsha, 410008, China

  • Xuanwu Hospital ,Capital Medical University

    RECRUITING

    Beijing, 100053, China

  • Yamaguchi University Hospital

    RECRUITING

    Ube, 755-8505, Japan

  • i Can Oncology Center

    RECRUITING

    Monterrey, 64710, Mexico

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