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

Last Updated   June 20, 2024 - 21:04

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OVERVIEW

  • Gender
    all
  • Age
    18+ years
  • Phase
    phase 2
    The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety.
  • Sites
    66 sites
  • Status
    Recruiting

SUMMARY

CIDP is a rare, chronic autoimmune disease of the peripheral nervous system characterized by progressive weakness and impaired sensation. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody (mAb) designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal Fc receptor. The study will consist of the following periods: (a) identification of participants with active CIDP (including screening [up to 4 weeks] and run-in [up to 12 weeks]); (b) open-label treatment with nipocalimab (Stage A) (12 weeks); (c) double-blind, placebo-controlled, randomized withdrawal (Stage B) (up to 52 weeks); and (d) an open-label extension (OLE) (until to 2 years after marketing authorization in the participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first). Participants who discontinue treatment and intend to withdraw from the study at any point during the treatment periods (Stage A, Stage B, or the OLE) will be requested to enter an 8-weeks follow-up after the last dose of study intervention. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarker evaluations will be assessed.

CONDITIONS

  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

ELIGIBILITY

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

* Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 (a score of 2 has to be exclusively from leg disability)

* 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

DETAILS

CIDP is a rare, chronic autoimmune disease of the peripheral nervous system characterized by progressive weakness and impaired sensation. Nipocalimab (also referred to as JNJ-80202135 or M281) is a fully human aglycosylated immunoglobulin (Ig)G1 monoclonal antibody (mAb) designed to selectively bind, saturate, and block the IgG binding site on the endogenous neonatal Fc receptor. The study will consist of the following periods: (a) identification of participants with active CIDP (including screening \[up to 4 weeks\] and run-in \[up to 12 weeks\]); (b) open-label treatment with nipocalimab (Stage A) (12 weeks); (c) double-blind, placebo-controlled, randomized withdrawal (Stage B) (up to 52 weeks); and (d) an open-label extension (OLE) (until to 2 years after marketing authorization in the participant's local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first). Participants who discontinue treatment and intend to withdraw from the study at any point during the treatment periods (Stage A, Stage B, or the OLE) will be requested to enter an 8-weeks follow-up after the last dose of study intervention. Efficacy, safety, pharmacokinetics (PK), immunogenicity, and biomarker evaluations will be assessed.

LOCATIONS

Locations in:
United States, United Kingdom, Taiwan, Spain, South Korea, Portugal, Poland, Japan, Greece, France, Czechia, China
Country (12) City or Province (66) Status
United States Austin, TX Austin Neuromuscular Center
RECRUITING
United States Centennial, CO IMMUNOe Health and Research Centers
RECRUITING
United States Charlotte, NC The Neurological Institute, PA
RECRUITING
United States Cleveland, OH Cleveland Clinic Main Campus
RECRUITING
United States Kansas City, KS University of Kansas Medical Center
RECRUITING
United States Maitland, FL Neurology Associates PA
RECRUITING
United States Milwaukee, WI Advocate Health - Aurora St. Luke's Medical Center
RECRUITING
United States New York, NY The Neurological Institute of New York
RECRUITING
United States Patchogue, NY South Shore Neurologic Associates - Patchogue
RECRUITING
United States Royal Oak, MI Beaumont Hospital Royal Oak
RECRUITING
United Kingdom Glasgow NHS Greater Glasgow and Clyde
RECRUITING
Taiwan Kaohsiung Kaohsiung Chang Gung Memorial Hospital
RECRUITING
Taiwan Taipei National Taiwan University Hospital
RECRUITING
Taiwan Taipei Shin Kong Wu Ho Su Memorial Hospital
RECRUITING
Spain Bilbao Hosp. Univ. de Basurto
RECRUITING
Spain Sevilla Hosp. Virgen Macarena
RECRUITING
South Korea Seoul Konkuk University Medical Center
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
Portugal Almada Hospital Garcia de Orta
RECRUITING
Portugal Braga, Braga Hospital de Braga
RECRUITING
Portugal Porto Centro Hospitalar de Sao Joao Epe
RECRUITING
Poland Chorzów Centrum Medyczne
RECRUITING
Poland Kraków Specjalistyczne Gabinety Lekarskie
RECRUITING
Japan Asahikawa, 01 Asahikawa Medical Center
RECRUITING
Japan Bunkyo Ku, 13 Tokyo Medical and Dental University Hospital
RECRUITING
Japan Chiba-shi Chiba University Hospital
RECRUITING
Japan Hamamatsu Seirei Hamamatsu General Hospital
RECRUITING
Japan Isehara, 14 Tokai University Hospital
RECRUITING
Japan Kobe City, 28 Kobe City Medical Center General Hospital
RECRUITING
Japan Kodaira-shi, 13 National Center of Neurology and Psychiatry
RECRUITING
Japan Koshigaya, 11 Saitama Medical Center
RECRUITING
Japan Kumamoto, 43 Kumamoto University Hospital
RECRUITING
Japan Nagoya Chubu Rosai Hospital
RECRUITING
Japan Nagoya-shi Nagoya University Hospital
RECRUITING
Japan Osaka Sayama shi, 27 Kindai University Hospital
RECRUITING
Japan Sendai-City, 04 National Hospital Organization Sendai Medical Center
RECRUITING
Japan Shimotsuga Gun Dokkyo Medical University Hospital
RECRUITING
Japan Shinjuku-ku, 13 Tokyo Women's Medical University Hospital
RECRUITING
Japan Tenri, 29 Tenri Hospital
RECRUITING
Japan Toyama-shi, 16 Toyama University Hospital
RECRUITING
Japan Ube Yamaguchi University Hospital
RECRUITING
Greece Patras Patras University Hospital
RECRUITING
Greece Thessaloniki Papageorgiou General Hospital Of Thessaloniki
RECRUITING
France Bordeaux CHU Bordeaux
RECRUITING
France Bron Hospices Civils de Lyon HCL
RECRUITING
France Le Kremlin Bicêtre Hopital de Bicetre
RECRUITING
France Nice Hopital PASTEUR
RECRUITING
France Strasbourg CHRU Strasbourg
RECRUITING
Czechia Hradec Králové Fakultni nemocnice Hradec Kralove
RECRUITING
Czechia Ostrava Fakultni nemocnice Ostrava
RECRUITING
Czechia Pardubice Pardubicka krajska nemocnice a s
RECRUITING
China Beijing, 11 Beijing Tiantan Hospital, Capital Medical University
RECRUITING
China Beijing, 11 Peking University First Hospital
RECRUITING
China Beijing, 11 Peking University Third Hospital
RECRUITING
China Beijing, 11 Xuanwu Hospital ,Capital Medical University
RECRUITING
China Changchun The First Hospital of Jilin University
RECRUITING
China Changsha The Third Xiangya Hospital of Central Sourth University
RECRUITING
China Changsha Xiangya Hospital Central South University
RECRUITING
China Chifeng Chifeng Municipal Hospital
RECRUITING
China Fuzhou Fujian Medical University Union Hospital
RECRUITING
China Guang Zhou The First Affiliated Hospital Sun Yat sen University
RECRUITING
China Jinan Qianfoshan hospital of Shandong Province
RECRUITING
China Nanchang The First Affiliated Hospital of NanChang University
RECRUITING
China Shanghai, 31 Huashan Hospital Fudan University
RECRUITING
China Shanghai, 31 Tong Ren Hospital Shanghai Jiao Tong University school of medicine
SUSPENDED
China Xi'an Xi 'an GaoXin Hospital
RECRUITING
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50

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10

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5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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