A Study of Nipocalimab in Participants With Active Idiopathic Inflammatory Myopathies
Condition(s) studied
Investigational drug(s) / intervention(s)
Nipocalimab: Nipocalimab will be administered intravenously in double-blind period and LTE period.
Placebo: Nipocalimab matching placebo will be administered intravenously in double-blind period.
Glucocorticoids: Prednisone or equivalent will be administered orally as Glucocorticoid.
Study summary
The purpose of this study is to evaluate the efficacy and safety of Nipocalimab versus placebo in participants with active idiopathic inflammatory myopathies (IIM).
Eligibility
Primary outcome measure(s)
- Percentage of Participants who Achieve at Least Minimal Improvement (Greater Than or Equal to [>=] 20) in IMACS TIS and on Less Than or Equal to (<=) 5 Milligrams per day (mg/day) of Oral Prednisone (or Equivalent) From Week 44 Through Week 52 — At Week 52
Percentage of participants who achieve at least minimal improvement (\>=20) in IMACS TIS at Week 52 and on \<=5 mg/day of oral prednisone (or equivalent) from Week 44 through Week 52 will be reported. International Myositis Assessment and Clinical Studies Total Improvement Score (IMACS TIS) is a standardized clinical response criteria to assess minimal, moderate and major clinical improvement in adult participants with idiopathic inflammatory myopathies (IIM). Minimal improvement is defined as IMACS TIS greater than or equal to (\>=) 20 in participants with IIM. The criteria use the 6 IMACS core set measures: physicians' global activity, patient global activity (PtGA), manual muscle testing (MMT)-8, muscle enzymes, myositis disease activity assessment tool (MDAAT), and health assessment questionnaire-disability index (HAQ-DI). The absolute percentage change in each measure with varying weights is combined to obtain a TIS on a scale of 0 to 100. Higher score indicates greater improvement.
Trial sites (57)
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Arthritis and Rheumatology Research PLLC | Phoenix | Arizona | |
| HonorHealth Neurology | Scottsdale | Arizona | |
| Attune Health Autoimmune and Inflamation Care and Research | Beverly Hills | California | |
| University of California Irvine Medical Center | Orange | California | |
| Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Torrance | California | |
| FM Clinical Research, LLC South Florida Neurology Associates, P. A. | Boca Raton | Florida | |
| Integral Rheumatology And Immunology Specialists | Plantation | Florida | |
| University of South Florida | Tampa | Florida | |
| Augusta University | Augusta | Georgia | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Johns Hopkins University | Baltimore | Maryland | |
| The Brigham and Women's Hospital, Inc. | Boston | Massachusetts | |
| Clinical Research Institute of Michigan, LLC | Saint Clair Shores | Michigan | |
| Wexner Medical Center at the Ohio State University | Columbus | Ohio | |
| Oregon Health and Science University | Portland | Oregon | |
| University of Pennsylvania - Perelman School of Medicine | Philadelphia | Pennsylvania | |
| ACME Research Arthritis and Osteoporosis Center | Orangeburg | South Carolina | |
| Nervie and Muscle Center of Texas | Houston | Texas | |
| University of Texas at Houston Medical School | Houston | Texas | |
| Lawson Health Research / London Health Sciences Center Research | London | Ontario | |
| AMIR Research | Montreal | Quebec | |
| Revmatologicky ustav | Prague | Czechia | |
| Hospital Pasteur | Nice | France | |
| Hopital Pitie Salpetriere | Paris | France | |
| Nouvel Hopital Civil | Strasbourg | France | |
| Charite Universitaetsmedizin Berlin | Berlin | Germany | |
| Klinikum der Universitaet Muenchen | München | Germany | |
| Immanuel Klinik Rudersdorf | Rüdersdorf Bei Berlin | Germany | |
| Orszagos Mozgasszervi Intezet ORFI Campus | Budapest | Hungary | |
| Debreceni Egyetem | Debrecen | Hungary | |
| A.O. Universitaria Ospedali Riuniti di Ancona | Ancona | Italy | |
| IRCSS Ospedale San Raffaele Turro | Milan | Italy | |
| Fondazione IRCCS Policlinico San Matteo | Pavia | Italy | |
| Fondazione Policlinico Universitario A Gemelli IRCCS | Roma | Italy | |
| National Hospital Organization Kyushu Medical Center | Fukuoka | Japan | |
| Fukushima Medical University Hospital | Fukushima | Japan | |
| St Marianna University Hospital | Kanagawa | Japan | |
| National Hospital Organization Osaka Minami Medical Center | Kawachi-Nagano | Japan | |
| Tokushukai Chiba-Nishi General Hospital | Matsudo-shi | Japan | |
| Shinshu University Hospital | Matsumoto | Japan |
+ 17 more sites — see the full list on the official registry below.
More Janssen Research & Development, LLC trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05379634 on ClinicalTrials.gov ↗ ← All trials in Italy