Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneur

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

Last Updated August 15, 2024

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CR109195

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 2

2
Sites
71 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

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, China, Colombia, Czechia, France, Germany, Greece, Japan, South Korea, Poland, Portugal, Spain, Taiwan, United Kingdom

Country (14)	City or Province (71)	Status
United States	Centennial IMMUNOe Health and Research Centers	RECRUITING
United States	Maitland Neurology Associates PA	RECRUITING
United States	Kansas City University of Kansas Medical Center	RECRUITING
United States	Baltimore Johns Hopkins Hospital	RECRUITING
United States	Royal Oak Beaumont Hospital Royal Oak	RECRUITING
United States	New York The Neurological Institute of New York	RECRUITING
United States	Patchogue South Shore Neurologic Associates - Patchogue	RECRUITING
United States	Charlotte The Neurological Institute, PA	RECRUITING
United States	Cleveland Cleveland Clinic Main Campus	RECRUITING
United States	Austin Austin Neuromuscular Center	RECRUITING
United States	Milwaukee Advocate Health - Aurora St. Luke's Medical Center	RECRUITING
China	Beijing Peking University First Hospital	RECRUITING
China	Beijing Xuanwu Hospital ,Capital Medical University	RECRUITING
China	Beijing Beijing Tiantan Hospital, Capital Medical University	RECRUITING
China	Beijing Peking University Third Hospital	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 Huashan Hospital Fudan University	RECRUITING
China	Shanghai Tong Ren Hospital Shanghai Jiao Tong University school of medicine	SUSPENDED
China	Xi'an Xi 'an GaoXin Hospital	RECRUITING
Colombia	Floridablanca Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca	RECRUITING
Colombia	Medellin Instituto Neurológico de Colombia	RECRUITING
Czechia	Hradec Králové Fakultni nemocnice Hradec Kralove	RECRUITING
Czechia	Ostrava Fakultni Nemocnice Ostrava	RECRUITING
Czechia	Pardubice Pardubicka krajska nemocnice a s	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
Germany	Hannover Medizinische Hochschule Hannover	RECRUITING
Greece	Patras Patras University Hospital	RECRUITING
Greece	Thessaloniki Papageorgiou General Hospital Of Thessaloniki	RECRUITING
Japan	Asahikawa National Hospital Organization Asahikawa Medical Center	RECRUITING
Japan	Bunkyo Ku Tokyo Medical and Dental University Hospital	RECRUITING
Japan	Chiba-shi Chiba University Hospital	RECRUITING
Japan	Hamamatsu Seirei Hamamatsu General Hospital	RECRUITING
Japan	Isehara Tokai University Hospital	RECRUITING
Japan	Kobe City Kobe City Medical Center General Hospital	RECRUITING
Japan	Kodaira-shi National Center of Neurology and Psychiatry	RECRUITING
Japan	Koshigaya Saitama Medical Center	RECRUITING
Japan	Kumamoto Kumamoto University Hospital	RECRUITING
Japan	Nagoya-shi Nagoya University Hospital	RECRUITING
Japan	Nagoya Chubu Rosai Hospital	RECRUITING
Japan	Osaka Sayama shi Kindai University Hospital	RECRUITING
Japan	Sendai-City National Hospital Organization Sendai Medical Center	RECRUITING
Japan	Shimotsuga Gun Dokkyo Medical University Hospital	RECRUITING
Japan	Shinjuku-ku Tokyo Women's Medical University Hospital	RECRUITING
Japan	Tenri Tenri Hospital	RECRUITING
Japan	Toyama-shi Toyama University Hospital	RECRUITING
Japan	Ube Yamaguchi University Hospital	RECRUITING
South Korea	Seoul Konkuk University Medical Center	RECRUITING
South Korea	Seoul Samsung Medical Center	RECRUITING
Poland	Chorzów Centrum Medyczne	RECRUITING
Poland	Kraków Specjalistyczne Gabinety Lekarskie	RECRUITING
Portugal	Almada Hospital Garcia de Orta	RECRUITING
Portugal	Braga Hospital de Braga	RECRUITING
Spain	Bilbao Hosp. Univ. de Basurto	RECRUITING
Spain	Sevilla Hosp. Virgen Macarena	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
United Kingdom	Glasgow NHS Greater Glasgow and Clyde	RECRUITING
Japan	Toon-shi Ehime University Hospital	RECRUITING
Portugal	Porto Centro Hospitalar de Sao Joao Epe	RECRUITING

Geo Locations

39.57916, -104.87692

28.62778, -81.36312

39.11417, -94.62746

39.29038, -76.61219

42.48948, -83.14465

40.71427, -74.00597

40.76565, -73.01511

35.22709, -80.84313

41.4995, -81.69541

30.26715, -97.74306

43.0389, -87.90647

39.9075, 116.39723

43.88, 125.32278

28.19874, 112.97087

42.26833, 118.96361

26.06139, 119.30611

23.1291999, 113.303

36.66833, 116.99722

28.68396, 115.85306

31.22222, 121.45806

34.25833, 108.92861

7.06222, -73.08644

6.25184, -75.56359

50.20923, 15.83277

49.83465, 18.28204

50.04075, 15.77659

44.84044, -0.5805

45.73333, 4.91667

48.81471, 2.36073

43.70313, 7.26608

48.58392, 7.74553

52.37052, 9.73322

38.24444, 21.73444

40.64361, 22.93086

43.77063, 142.36489

35.37517, 139.92991

35.6, 140.11667

34.7, 137.73333

35.39932, 139.31019

34.6913, 135.183

35.7370602, 139.475521

35.89035, 139.78916

32.80589, 130.69182

35.18147, 136.90641

34.69374, 135.50218

38.26667, 140.86667

36.4729244, 139.823264

35.2946, 139.57059

34.58333, 135.83333

36.7, 137.21667

33.94306, 131.25111

37.566, 126.9784

50.30582, 18.9742

50.06143, 19.93658

38.67902, -9.1569

41.55032, -8.42005

43.26271, -2.92528

37.38283, -5.97317

22.61626, 120.31333

25.04776, 121.53185

55.86515, -4.25763

33.79427, 132.89011

41.14961, -8.61099

Indicates 50+ sites in this region: click to zoom in.

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

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

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

39.57916, -104.87692

28.62778, -81.36312

39.11417, -94.62746

39.29038, -76.61219

42.48948, -83.14465

40.71427, -74.00597

40.76565, -73.01511

35.22709, -80.84313

41.4995, -81.69541

30.26715, -97.74306

43.0389, -87.90647

39.9075, 116.39723

39.9075, 116.39723

39.9075, 116.39723

39.9075, 116.39723

43.88, 125.32278

28.19874, 112.97087

28.19874, 112.97087

42.26833, 118.96361

26.06139, 119.30611

23.1291999, 113.303

36.66833, 116.99722

28.68396, 115.85306

31.22222, 121.45806

31.22222, 121.45806

34.25833, 108.92861

7.06222, -73.08644

6.25184, -75.56359

50.20923, 15.83277

49.83465, 18.28204

50.04075, 15.77659

44.84044, -0.5805

45.73333, 4.91667

48.81471, 2.36073

43.70313, 7.26608

48.58392, 7.74553

52.37052, 9.73322

38.24444, 21.73444

40.64361, 22.93086

43.77063, 142.36489

35.37517, 139.92991

35.6, 140.11667

34.7, 137.73333

35.39932, 139.31019

34.6913, 135.183

35.7370602, 139.475521

35.89035, 139.78916

32.80589, 130.69182

35.18147, 136.90641

35.18147, 136.90641

34.69374, 135.50218

38.26667, 140.86667

36.4729244, 139.823264

35.2946, 139.57059

34.58333, 135.83333

36.7, 137.21667

33.94306, 131.25111

37.566, 126.9784

37.566, 126.9784

50.30582, 18.9742

50.06143, 19.93658

38.67902, -9.1569

41.55032, -8.42005

43.26271, -2.92528

37.38283, -5.97317

22.61626, 120.31333

25.04776, 121.53185

25.04776, 121.53185

55.86515, -4.25763