New drug aims to tame muscle inflammation in myositis
NCT ID NCT05379634
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether nipocalimab, given intravenously, can improve symptoms of active idiopathic inflammatory myopathies (myositis) better than a placebo. About 36 adults with myositis will receive either nipocalimab or a placebo, along with standard steroid treatment. The main goal is to see if more people on nipocalimab achieve at least minimal improvement in muscle strength and daily function while using lower steroid doses.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Nipocalimab (given intravenously)
What this could lead to
If it works, this could point toward a new treatment option for myositis that helps control symptoms and reduces the need for steroids.
What could go wrong
This is a small, early-phase trial with only 36 participants. The drug may not prove more effective than placebo, and side effects are still being studied.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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A.O. Universitaria Ospedali Riuniti di Ancona
Ancona, 60126, Italy
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ACME Research Arthritis and Osteoporosis Center
Orangeburg, South Carolina, 29118, United States
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AMIR Research
Montreal, Quebec, H4A 3T2, Canada
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Ajou University Hospital
Suwon, 16499, South Korea
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Arizona Arthritis and Rheumatology Research PLLC
Phoenix, Arizona, 85032, United States
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Attune Health Autoimmune and Inflamation Care and Research
Beverly Hills, California, 90211, United States
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Augusta University
Augusta, Georgia, 30912, United States
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CITER Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas S A de C V
México, 06700, Mexico
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Centro Integral en Reumatologia S A de C V
Guadalajara, 44160, Mexico
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Centro de Estudios de Investigacion Basica y Clinica, S.C.
Guadalajara, 44690, Mexico
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Charite Universitaetsmedizin Berlin
Berlin, 10117, Germany
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Clinical Research Institute of Michigan, LLC
Saint Clair Shores, Michigan, 48081, United States
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Debreceni Egyetem
Debrecen, 4032, Hungary
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FM Clinical Research, LLC South Florida Neurology Associates, P. A.
Boca Raton, Florida, 33487, United States
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Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
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Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
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Fukushima Medical University Hospital
Fukushima, 960 1295, Japan
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HonorHealth Neurology
Scottsdale, Arizona, 85251, United States
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Hopital Pitie Salpetriere
Paris, 75013, France
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Hosp. Univ. Marques de Valdecilla
Santander, 39008, Spain
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Hosp. Univ. de Bellvitge
Barcelona, 08907, Spain
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Hosp. Univ. de La Paz
Madrid, 28046, Spain
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Hospital Pasteur
Nice, 06000, France
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IRCSS Ospedale San Raffaele Turro
Milan, 20127, Italy
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Immanuel Klinik Rudersdorf
Rüdersdorf Bei Berlin, 15562, Germany
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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080, Mexico
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Integral Rheumatology And Immunology Specialists
Plantation, Florida, 33324, United States
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Johns Hopkins University
Baltimore, Maryland, 21224, United States
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Klinikum der Universitaet Muenchen
München, 80336, Germany
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Lawson Health Research / London Health Sciences Center Research
London, Ontario, N6C 2R5, Canada
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Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
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Narodowy Instytut Geriatrii Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher
Warsaw, 02 637, Poland
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National Hospital Organization Kyushu Medical Center
Fukuoka, 810 8563, Japan
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National Hospital Organization Osaka Minami Medical Center
Kawachi-Nagano, 586 8521, Japan
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Nervie and Muscle Center of Texas
Houston, Texas, 77030, United States
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Nippon Medical School Hospital
Tokyo, 113 8603, Japan
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Nouvel Hopital Civil
Strasbourg, 67091, France
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Oregon Health and Science University
Portland, Oregon, 97239, United States
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Orszagos Mozgasszervi Intezet ORFI Campus
Budapest, 1023, Hungary
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Revmatologicky ustav
Prague, 128 50, Czechia
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Salford Royal Hospital
Salford, M6 8HD, United Kingdom
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Seoul National University Hospital
Seoul, 03080, South Korea
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Shinshu University Hospital
Matsumoto, 390-8621, Japan
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St Marianna University Hospital
Kanagawa, 216 8511, Japan
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St. Luke's International Hospital
Tokyo, 104 8560, Japan
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Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85 168, Poland
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The Brigham and Women's Hospital, Inc.
Boston, Massachusetts, 02115, United States
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Tohoku University Hospital
Sendai, 980 8574, Japan
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Tokushukai Chiba-Nishi General Hospital
Matsudo-shi, 270-2251, Japan
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University College London Hospitals NHSFT
London, WC1N 3BG, United Kingdom
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University of California Irvine Medical Center
Orange, California, 92868, United States
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University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
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University of Pennsylvania - Perelman School of Medicine
Philadelphia, Pennsylvania, 19104, United States
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University of South Florida
Tampa, Florida, 33612, United States
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University of Texas at Houston Medical School
Houston, Texas, 77030, United States
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Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
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Wexner Medical Center at the Ohio State University
Columbus, Ohio, 43203, United States