Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Last Updated   March 27, 2024 - 21:02
OVERVIEW
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Gender
all -
Age
years -
Phase
phase 2The drug or treatment is given to a larger group of people to see if it is effective and to better understand its safety. -
Sites
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
Country (11) | City or Province (57) | Status |
United States | Austin, TX Austin Neuromuscular Center |
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United States | Centennial, CO IMMUNOe Health and Research Centers |
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United States | Charlotte, NC The Neurological Institute, PA |
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United States | Cleveland, OH Cleveland Clinic Main Campus |
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United States | Kansas City, KS University of Kansas Medical Center |
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United States | Maitland, FL Neurology Associates PA |
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United States | Milwaukee, WI Advocate Health - Aurora St. Luke's Medical Center |
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United States | New York, NY The Neurological Institute of New York |
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United States | Patchogue, NY South Shore Neurologic Associates - Patchogue |
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United Kingdom | Glasgow NHS Greater Glasgow and Clyde |
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Taiwan | Taipei National Taiwan University Hospital |
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Taiwan | Taipei Shin Kong Wu Ho Su Memorial Hospital |
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Spain | Sevilla Hosp. Virgen Macarena |
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South Korea | Seoul Konkuk University Medical Center |
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South Korea | Seoul Samsung Medical Center |
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Poland | Chorzów Centrum Medyczne |
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Poland | Kraków Specjalistyczne Gabinety Lekarskie |
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Japan | Asahikawa, 01 Asahikawa Medical Center |
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Japan | Bunkyo-Ku, 13 Tokyo Medical and Dental University Hospital |
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Japan | Chiba-shi Chiba University Hospital |
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Japan | Hamamatsu Seirei Hamamatsu General Hospital |
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Japan | Hyogo, 28 Kobe City Medical Center General Hospital |
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Japan | Isehara, 14 Tokai University Hospital |
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Japan | Kodaira-shi, 13 National Center of Neurology and Psychiatry |
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Japan | Koshigaya, 11 Saitama Medical Center |
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Japan | Kumamoto, 43 Kumamoto University Hospital |
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Japan | Nagoya Chubu Rosai Hospital |
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Japan | Nagoya-shi Nagoya University Hospital |
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Japan | Osaka-Sayama-shi, 27 Kindai University Hospital |
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Japan | Sendai-City, 04 National Hospital Organization Sendai Medical Center |
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Japan | Shimotsuga-gun Dokkyo Medical University Hospital |
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Japan | Shinjuku-ku, 13 Tokyo Women's Medical University Hospital |
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Japan | Tenri, 29 Tenri Hospital |
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Japan | Toyama-shi, 16 Toyama University Hospital |
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Japan | Ube Yamaguchi University Hospital |
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Greece | Thessaloniki 'Papageorgiou' General Hospital of Thessaloniki |
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France | Bordeaux CHU Bordeaux |
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France | Bron Hospices Civils de Lyon HCL |
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France | Le Kremlin Bicêtre Hopital de Bicetre |
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France | Strasbourg CHRU Strasbourg |
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Czechia | Hradec Králové Fakultni nemocnice Hradec Kralove |
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Czechia | Ostrava Fakultni nemocnice Ostrava |
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Czechia | Pardubice Pardubicka krajska nemocnice a.s. |
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China | Beijing, 11 Beijing Tiantan Hospital, Capital Medical University |
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China | Beijing, 11 Peking University First Hospital |
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China | Beijing, 11 Peking University Third Hospital |
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China | Beijing, 11 Xuanwu Hospital ,Capital Medical University |
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China | Changchun The First Hospital of Jilin University |
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China | Changsha The Third Xiangya Hospital of Central Sourth University |
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China | Changsha Xiangya Hospital Central South University |
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China | Chifeng Chifeng Municipal Hospital |
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China | Fuzhou Fujian Medical University Union Hospital |
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China | Jinan Qianfoshan hospital of Shandong Province |
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China | Nanchang The First Affiliated Hospital of NanChang University |
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China | Shanghai, 31 Huashan Hospital Fudan University |
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China | Shanghai, 31 Tong Ren Hospital Shanghai Jiao Tong University school of medicine |
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China | Xi'an Xi 'an GaoXin Hospital |
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