A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 5, 2022

Primary Completion Date

September 4, 2025

Study Completion Date

September 16, 2026

Conditions
Myositis
Interventions
DRUG

Nipocalimab

Nipocalimab will be administered intravenously in double-blind period and LTE period.

OTHER

Placebo

Nipocalimab matching placebo will be administered intravenously in double-blind period.

DRUG

Glucocorticoids

Prednisone or equivalent will be administered orally as Glucocorticoid.

Trial Locations (57)

1023

Orszagos Mozgasszervi Intezet ORFI Campus, Budapest

4032

Debreceni Egyetem, Debrecen

10117

Charite Universitaetsmedizin Berlin, Berlin

14080

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City

15562

Immanuel Klinik Rüdersdorf, Rüdersdorf Bei Berlin

16499

Ajou University Hospital, Suwon

19104

University of Pennsylvania - Perelman School of Medicine, Philadelphia

20127

IRCSS Ospedale San Raffaele Turro, Milan

21224

Johns Hopkins University, Baltimore

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28046

Hosp. Univ. de La Paz, Madrid

29118

ACME Research Arthritis and Osteoporosis Center, Orangeburg

30912

Augusta University, Augusta

33324

Integral Rheumatology And Immunology Specialists, Plantation

33487

FM Clinical Research, LLC South Florida Neurology Associates, P. A., Boca Raton

33612

University of South Florida, Tampa

39008

Hosp. Univ. Marques de Valdecilla, Santander

43203

Wexner Medical Center at the Ohio State University, Columbus

44160

Centro Integral en Reumatologia S A de C V, Guadalajara

44690

Centro de Estudios de Investigacion Basica y Clinica, S.C., Guadalajara

48081

Clinical Research Institute of Michigan, LLC, Saint Clair Shores

60126

A.O. Universitaria Ospedali Riuniti di Ancona, Ancona

66160

University of Kansas Medical Center, Kansas City

67091

Nouvel Hopital Civil, Strasbourg

75013

Hôpital Pitié-Salpétrière, Paris

77030

Nervie and Muscle Center of Texas, Houston

University of Texas at Houston Medical School, Houston

80336

Klinikum der Universitaet Muenchen, München

85032

Arizona Arthritis and Rheumatology Research PLLC, Phoenix

85251

HonorHealth Neurology, Scottsdale

90211

Attune Health Autoimmune and Inflamation Care and Research, Beverly Hills

90502

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

92868

University of California Irvine Medical Center, Orange

97239

Oregon Health and Science University, Portland

02115

The Brigham and Women's Hospital, Inc., Boston

N6C 2R5

Lawson Health Research / London Health Sciences Center Research, London

H4A 3T2

AMIR Research, Montreal

128 50

Revmatologicky ustav, Prague

06000

Hospital Pasteur, Nice

00168

Fondazione Policlinico Universitario A Gemelli IRCCS, Roma

810 8563

National Hospital Organization Kyushu Medical Center, Fukuoka

960 1295

Fukushima Medical University Hospital, Fukushima

216 8511

St Marianna University Hospital, Kanagawa

586 8521

National Hospital Organization Osaka Minami Medical Center, Kawachi-Nagano

270-2251

Tokushukai Chiba-Nishi General Hospital, Matsudo-shi

390-8621

Shinshu University Hospital, Matsumoto

980-8574

Tohoku University Hospital, Sendai

104 8560

St. Luke's International Hospital, Tokyo

113 8603

Nippon Medical School Hospital, Tokyo

06700

CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V, México

85 168

Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Bydgoszcz

02 637

Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher, Warsaw

03080

Seoul National University Hospital, Seoul

08907

Hosp. Univ. de Bellvitge, Barcelona

EH4 2XU

Western General Hospital, Edinburgh

WC1N 3BG

University College London Hospitals NHSFT, London

M6 8HD

Salford Royal Hospital, Salford

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY