NCT05327114RecruitingPhase 2/3
Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
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)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 201 (estimated)
- First submitted
- 7 Apr 2022
- Start date
- 23 Sept 2022
- Primary completion date
- 15 Dec 2026
- Lead sponsor
- Janssen Research & Development, LLC
- NCT number
- NCT05327114
- EU CT number
- 2023-508425-28-00
- EudraCT number
- 2021-003234-37
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 201
- From 23 Sept 2022 to the primary completion date, 15 Dec 2026
- 119 sites in 19 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus
- Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
Lab values
- 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
Other
- Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
- Other protocol-defined exclusion criteria will apply
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (119)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Fleni Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Recruiting |
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Active, not recruiting |
| Hospital Gral Agudos Ignacio Pirovano Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Completed |
| INECO Neurociencias Oroño Coordinator of this site? Confirm its status | Rosario | Argentina | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Completed |
| Gold Coast University Hospital Coordinator of this site? Confirm its status | Parkwood | Australia | Completed |
| The Ottawa Hospital Ottawa NeuroMuscular Centre Coordinator of this site? Confirm its status | Ottawa | Canada | Recruiting |
| Beijing Tiantan Hospital,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Active, not recruiting |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Completed |
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Completed |
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Active, not recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Active, not recruiting |
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Completed |
| The Third Xiangya Hospital of Central Sourth University Coordinator of this site? Confirm its status | Changsha | China | Active, not recruiting |
| Sichuan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Chengdu | China | Completed |
| Chifeng Municipal Hospital Coordinator of this site? Confirm its status | Chifeng | China | Completed |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Active, not recruiting |
| The First Affiliated Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Active, not recruiting |
| Qianfoshan Hospital of Shandong Province Coordinator of this site? Confirm its status | Jinan | China | Completed |
| Qilu Hospital of Shandong University Coordinator of this site? Confirm its status | Jinan | China | Active, not recruiting |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Active, not recruiting |
| Huashan Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Active, not recruiting |
| Tong Ren Hospital,Shanghai Jiao Tong University School Of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Completed |
| Renmin Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Completed |
| Tangdu hospital the Fourth Military Medical Coordinator of this site? Confirm its status | Xi'an | China | Completed |
| Xi'an Gaoxin Hospital Coordinator of this site? Confirm its status | Xi’an | China | Active, not recruiting |
| Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca Coordinator of this site? Confirm its status | Floridablanca | Colombia | Completed |
| Instituto Neurológico de Colombia Coordinator of this site? Confirm its status | Medellín | Colombia | Active, not recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Active, not recruiting |
| Juedisches Krankenhaus Berlin Stiftung Des Buergerlichen Rechts Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Katholisches Klinikum Bochum gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Active, not recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Active, not recruiting |
| Martha-Maria Krankenhaus Halle-Doelau gGmbH Coordinator of this site? Confirm its status | Halle (saale) | Germany | Active, not recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Universitaetsklinikum Leipzig Aor Coordinator of this site? Confirm its status | Leipzig | Germany | Active, not recruiting |
| Medizinische Versorgungszentren St. Josefs-Krankenhaus Potsdam GmbH Coordinator of this site? Confirm its status | Potsdam | Germany | Active, not recruiting |
| Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Coordinator of this site? Confirm its status | Ulm | Germany | Active, not recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Active, not recruiting |
| Hospital Universitario Donostia Coordinator of this site? Confirm its status | Donostia | Spain | Active, not recruiting |
| Hospital Clínico San Carlos Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Hospital Pierre Wertheimer Coordinator of this site? Confirm its status | Bron | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Le Kremlin-Bicetre | France | Active, not recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Active, not recruiting |
| Fondation A. de Rothschild Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| University Hospitals Birmingham NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Completed |
| Royal Devon & Exeter Hospital Coordinator of this site? Confirm its status | Devon | United Kingdom | Completed |
| NHS Greater Glasgow and Clyde Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Active, not recruiting |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Completed |
| Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Active, not recruiting |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| General Hospital Of Thessaloniki Papageorgiou Coordinator of this site? Confirm its status | Efkarpia | Greece | Active, not recruiting |
| University General Hospital of Thessaloniki - AHEPA Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genoa | Italy | Active, not recruiting |
| Casa Di Cura Igea S.p.A. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Active, not recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Azienda Ospedaliera Policlinico Universitario Tor Vergata Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| National Hospital Organization Asahikawa Medical Center Coordinator of this site? Confirm its status | Asahikawa | Japan | Active, not recruiting |
| Institute of Science Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyō City | Japan | Active, not recruiting |
| Chiba University Hospital Coordinator of this site? Confirm its status | Chiba | Japan | Completed |
| Seirei Hamamatsu General Hospital Coordinator of this site? Confirm its status | Hamamatsu | Japan | Active, not recruiting |
| Tokai University Hospital Coordinator of this site? Confirm its status | Isehara | Japan | Active, not recruiting |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Completed |
| National Center of Neurology and Psychiatry Coordinator of this site? Confirm its status | Kodaira-shi | Japan | Active, not recruiting |
| Saitama Medical Center Coordinator of this site? Confirm its status | Koshigaya | Japan | Active, not recruiting |
| Kumamoto University Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Completed |
| Chubu Rosai Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Active, not recruiting |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Active, not recruiting |
| Kindai University Hospital Coordinator of this site? Confirm its status | Osaka Sayama Shi | Japan | Completed |
| National Hospital Organization Sendai Medical Center Coordinator of this site? Confirm its status | Sendai | Japan | Active, not recruiting |
| Dokkyo Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuga-gun | Japan | Completed |
| Tokyo Women's Medical University Hospital Coordinator of this site? Confirm its status | Shinjuku-ku | Japan | Completed |
| Tenri Hospital Coordinator of this site? Confirm its status | Tenri | Japan | Completed |
| Ehime University Hospital Coordinator of this site? Confirm its status | Toon-shi | Japan | Completed |
| Toyama University Hospital Coordinator of this site? Confirm its status | Toyama | Japan | Completed |
| Yamaguchi University Hospital Coordinator of this site? Confirm its status | Ube | Japan | Completed |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| KyungHee University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Completed |
| i Can Oncology Center Coordinator of this site? Confirm its status | Monterrey | Mexico | Completed |
| Clinical Research Institute S.C. Coordinator of this site? Confirm its status | Tlalnepantla | Mexico | Recruiting |
| Clinirem Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Clinical Research Center Sp z o o Medic R Sp k Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Unidade Local De Saude De Almada-Seixal E.P.E. Coordinator of this site? Confirm its status | Almada | Portugal | Active, not recruiting |
| CCAB Centro Clinico Academico Braga Associacao Coordinator of this site? Confirm its status | Braga | Portugal | Active, not recruiting |
| Centro Hospitalar Universitario Sao Joao E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Completed |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Active, not recruiting |
| Shin Kong Wu Ho Su Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Active, not recruiting |
| Augusta University Coordinator of this site? Confirm its status | Augusta | United States | Completed |
| Austin Neuromuscular Center Coordinator of this site? Confirm its status | Austin | United States | Completed |
| Johns Hopkins Hospital Coordinator of this site? Confirm its status | Baltimore | United States | Completed |
| Boston Clinical Trials Coordinator of this site? Confirm its status | Boston | United States | Completed |
| IMMUNOe Health and Research Centers Coordinator of this site? Confirm its status | Centennial | United States | Active, not recruiting |
| The Neurological Institute PA Coordinator of this site? Confirm its status | Charlotte | United States | Completed |
| Cleveland Clinic - Main Campus Coordinator of this site? Confirm its status | Cleveland | United States | Active, not recruiting |
| Healthcare Innovations Institute Inc Coordinator of this site? Confirm its status | Coral Springs | United States | Completed |
| Kansas City Veterans Affairs Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Completed |
| University of Kansas Medical Center Coordinator of this site? Confirm its status | Kansas City | United States | Completed |
| Neurology Associates PA Coordinator of this site? Confirm its status | Maitland | United States | Completed |
| ALS Center at the University of Miami Coordinator of this site? Confirm its status | Miami | United States | Active, not recruiting |
| Advocate Health - Aurora St. Luke's Medical Center Coordinator of this site? Confirm its status | Milwaukee | United States | Active, not recruiting |
| The Neurological Institute of New York Coordinator of this site? Confirm its status | New York | United States | Completed |
| South Shore Neurologic Associates - Patchogue Coordinator of this site? Confirm its status | Patchogue | United States | Completed |
| Beaumont Hospital, Royal Oak Coordinator of this site? Confirm its status | Royal Oak | United States | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.