Phase
Condition
Myositis
Treatment
Nipocalimab
Placebo
Glucocorticoids
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Disease classification criteria: Participant meets the diagnostic criteria ofprobable or definite idiopathic inflammatory myopathies (IIM) based on 2017 TheEuropean League Against Rheumatism (EULAR)/American College of Rheumatology (ACR)classification criteria for adult IIM at least 6 weeks prior to first administrationof the study intervention
If a participant is on regular or as needed treatment with low potency topicalglucocorticoids (GC) that are allowed in the study or topical tacrolimus (TAC) totreat skin lesions, the dose and frequency should be stable for greater than orequal to (>=) 4 weeks prior to first administration of the study intervention aswell as maintained at the same dose until Week 52 of the study
Antibody positivity criteria: Any 1 of the myositis-specific antibodies (MSAs)positive: dermatomyositis (DM): anti-Mi-2 (Mi-2/nucleosome remodeling anddeacetylase [NuRD] complex), anti-transcription intermediary factor 1-Gamma (TIF1-Gamma), anti- nuclear matrix protein 2 (NXP-2), anti-small ubiquitin-likemodifier-1 activating enzyme; anti- antimelanoma differentiation-associated gene 5 (MDA-5) antibodies. Or immune-mediated necrotizing myopathy (IMNM): anti- signalrecognition particle (SRP) and anti- 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibodies. Or anti-synthetase syndrome (ASyS): anti- histidyl- ribonucleicacid [tRNA] synthetase (Jo-1), anti- threonyl-tRNA synthetase (PL7), anti-alanyl-tRNA synthetase (PL12), anti- isoleucyl-tRNA synthetase (OJ), and anti-glycyl-tRNA synthetase (EJ) antibodies. If all MSAs are negative or more than 1 MSAis positive within different subtypes (defined by the central laboratory) atscreening, the tests should be repeated during the screening period. If the sameresults are observed at retesting, the participant should not be enrolled in thestudy
Exclusion
Exclusion Criteria:
Has a juvenile myositis diagnosis and now >=18 years old
Has cancer-associated myositis defined as cancer diagnosis within 3 years ofmyositis diagnosis except for cervical carcinoma in situ and non-melanoma skincancer (squamous cell carcinoma, basal cell carcinoma of the skin)
Has comorbidities (example, asthma, chronic obstructive pulmonary disease [COPD])which have required 3 or more courses of oral GC within 1 year prior to screening
Has a history of primary immunodeficiency or secondary immunodeficiency not relatedto the treatment of the participants IIM
Has experienced myocardial infarction (MI), unstable ischemic heart disease, orstroke within 12 weeks of screening
Study Design
Connect with a study center
Lawson Health Research / London Health Sciences Center Research
London, Ontario N6C 2R5
CanadaSite Not Available
AMIR Research
Montreal, Quebec H4A 3T2
CanadaSite Not Available
Revmatologicky ustav
Praha 2, 128 50
CzechiaSite Not Available
Hospital Pasteur
Nice Cedex 1, 06000
FranceSite Not Available
CHU de Nice, Hopital de l'Archet
Nice Cedex 3, 06200
FranceSite Not Available
Hôpital Pitié-Salpétrière
Paris, 75013
FranceSite Not Available
Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
Strasbourg, 67098
FranceSite Not Available
Nouvel Hopital Civil
Strasbourg cedex, 67091
FranceSite Not Available
Charite Universitaetsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Charite Universitatsmedizin Berlin
Berlin, 10117
GermanySite Not Available
Charité Universitätsmedizin Berlin
Berlin, 10117
GermanyActive - Recruiting
Klinikum der Universitaet Muenchen
München, 80336
GermanySite Not Available
Immanuel Klinik Rüdersdorf
Rüdersdorf Bei Berlin, 15562
GermanySite Not Available
Orszagos Mozgasszervi Intezet ORFI Campus
Budapest, 1023
HungarySite Not Available
Országos Mozgásszervi Intézet ORFI telephely
Budapest, 1023
HungaryActive - Recruiting
Debreceni Egyetem
Debrecen, 4032
HungarySite Not Available
A.O. Universitaria Ospedali Riuniti di Ancona
Ancona, 60126
ItalySite Not Available
IRCCS Ospedale San Raffaele HSR
Milano, 20132
ItalyActive - Recruiting
IRCSS Ospedale San Raffaele Turro
Milano, 20127
ItalySite Not Available
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
ItalySite Not Available
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
Arcispedale Santa Maria Nuova - IRCCS
Reggio Emilia, 42123
ItalySite Not Available
Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168
ItalySite Not Available
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
ItalySite Not Available
National Hospital Organization Kyushu Medical Center
Fukuoka, 810 8563
JapanSite Not Available
Fukushima Medical University Hospital
Fukushima, 960 1295
JapanSite Not Available
St Marianna University Hospital
Kanagawa, 216 8511
JapanSite Not Available
St.Marianna University Hospital
Kanagawa, 216-8511
JapanActive - Recruiting
National Hospital Organization Osaka Minami Medical Center
Kawachi Nagano, 586 8521
JapanSite Not Available
National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, 586-8521
JapanSite Not Available
Chiba-Nishi General Hospital
Matsudo-shi, 270-2251
JapanActive - Recruiting
Tokushukai Chiba-Nishi General Hospital
Matsudo-shi, 270-2251
JapanSite Not Available
Shinshu University Hospital
Matsumoto, 390-8621
JapanSite Not Available
Tohoku University Hospital
Sendai-Shi, 980-8574
JapanSite Not Available
Nippon Medical School Hospital
Tokyo, 113 8603
JapanSite Not Available
St. Luke's International Hospital
Tokyo, 104 8560
JapanSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Ajou University Hospital
Suwon-si, 16499
Korea, Republic ofSite Not Available
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Ciudad de Mexico, 14080
MexicoSite Not Available
Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán
Ciudad de Mexico, 14080
MexicoSite Not Available
Centro Integral en Reumatologia S A de C V
Guadalajara, 44160
MexicoSite Not Available
Centro Integral en Reumatología S.A de C.V.
Guadalajara, 44160
MexicoActive - Recruiting
Centro de Estudios de Investigacion Basica y Clinica, S.C.
Guadalajara, 44690
MexicoSite Not Available
CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
Mexico, 06700
MexicoSite Not Available
CLIDITER S A de C V
México, 06700
MexicoSite Not Available
CLIDITER, S.A. de C.V.
México, 06700
MexicoActive - Recruiting
Academisch Medisch Centrum Universiteit van Amsterdam
Amsterdam, 105 AZ
NetherlandsSite Not Available
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85 168
PolandSite Not Available
Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
PolandActive - Recruiting
Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warszawa, 02 637
PolandSite Not Available
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warszawa, 02-637
PolandActive - Recruiting
Hosp. Univ. De Bellvitge
Barcelona, 08907
SpainActive - Recruiting
Hosp. Univ. de Bellvitge
Barcelona, 08907
SpainSite Not Available
Hosp. Univ. de La Paz
Madrid, 28046
SpainSite Not Available
Hosp. Univ. Marques de Valdecilla
Santander, 39008
SpainSite Not Available
Western General Hospital
Edinburgh, EH4 2XU
United KingdomSite Not Available
University College London Hospitals NHSFT
London, WC1N 3BG
United KingdomSite Not Available
Salford Royal Hospital
Manchester, M6 8HD
United KingdomSite Not Available
Salford Royal Hospital
Salford, M6 8HD
United KingdomSite Not Available
Arizona Arthritis and Rheumatology Research PLLC
Phoenix, Arizona 85032
United StatesSite Not Available
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona 85032
United StatesActive - Recruiting
HonorHealth Neurology
Scottsdale, Arizona 85251
United StatesSite Not Available
Attune Health Autoimmune and Inflamation Care and Research
Beverly Hills, California 90211
United StatesSite Not Available
University of California Los Angeles
Los Angeles, California 90095
United StatesSite Not Available
University of California Irvine Medical Center
Orange, California 92868
United StatesSite Not Available
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California 90502
United StatesSite Not Available
Yale University
New Haven, Connecticut 06519
United StatesSite Not Available
FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Boca Raton, Florida 33487
United StatesSite Not Available
Integral Rheumatology & Immunology Specialists
Plantation, Florida 33324
United StatesActive - Recruiting
Integral Rheumatology And Immunology Specialists
Plantation, Florida 33324
United StatesSite Not Available
University of South Florida
Tampa, Florida 33612
United StatesSite Not Available
Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesSite Not Available
Johns Hopkins University
Baltimore, Maryland 21224
United StatesSite Not Available
The Brigham and Women's Hospital, Inc.
Boston, Massachusetts 02115
United StatesSite Not Available
Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan 48081
United StatesSite Not Available
Wexner Medical Center at the Ohio State University
Columbus, Ohio 43203
United StatesSite Not Available
Oregon Health and Science University
Portland, Oregon 97239
United StatesSite Not Available
University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
ACME Research Arthritis and Osteoporosis Center
Orangeburg, South Carolina 29118
United StatesSite Not Available
Nervie and Muscle Center of Texas
Houston, Texas 77030
United StatesSite Not Available
University of Texas at Houston Medical School
Houston, Texas 77030
United StatesSite Not Available
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