Placebo: Placebo-matching nerandomilast
Nerandomilast: Nerandomilast
This study is open to adults aged 18 and older who have a condition known as active idiopathic inflammatory myopathy (IIM) or myositis. People can participate if they have a specific type of myositis. The purpose of this study is to find out whether a medicine called nerandomilast improves IIM symptoms.
Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take nerandomilast or placebo twice a day for 1 year.
Participants are in the study for about 1 year and 2 months. During this time, they visit the study site at least 16 times. During this time, doctors regularly check the participant's health, IIM symptoms, and take note of any unwanted effects. Participants fill in questionnaires about their IIM symptoms and how IIM impacts their quality of life. The results are compared between the 2 groups to see whether the treatment works.
| Facility | City | Region | Status |
|---|---|---|---|
| Arizona Neuromuscular Research Center | Phoenix | Arizona | |
| Mayo Clinic | Scottsdale | Arizona | |
| University of California Irvine | Irvine | California | |
| University of California Los Angeles | Los Angeles | California | |
| University of California San Francisco | San Francisco | California | |
| University of Colorado Denver | Aurora | Colorado | |
| Heuer M.D. Research, Inc | Orlando | Florida | |
| Kansas University Medical Center | Fairway | Kansas | |
| Johns Hopkins Hospital | Baltimore | Maryland | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| University of Michigan | Ann Arbor | Michigan | |
| Mayo Clinic, Rochester | Rochester | Minnesota | |
| Washington University School of Medicine | St Louis | Missouri | |
| Northwell Health | Great Neck | New York | |
| Cleveland Clinic | Cleveland | Ohio | |
| Paramount Medical Research and Consulting | Middleburg Heights | Ohio | |
| Oregon Health and Sciences University | Portland | Oregon | |
| University of Pennsylvania | Philadelphia | Pennsylvania | |
| West Tennessee Research Institute | Jackson | Tennessee | |
| Helios CR, Inc - Dallas | Dallas | Texas | |
| Nerve and Muscle Center of Texas | Houston | Texas | |
| Bioclinic Research | C.a.b.a | Argentina | |
| Centro Argentino de Investigacion (CADI)-Diagnostico Medico | CABA | Argentina | |
| Instituto de Investigacion Clinica TyT | CABA | Argentina | |
| Instituto Medico Especializado | Capital Federal | Argentina | |
| Framingham Centro Medico | La Plata | Argentina | |
| Instituto Medico CER | Quilmes | Argentina | |
| Sanatorio de la Mujer | Rosario | Argentina | |
| Centro de Investigaciones Medicas Tucuman | San Miguel de Tucumán | Argentina | |
| Alto Dorrego Consultorios | Villa Nueva | Argentina | |
| Wollongong Hospital | Wollongong | New South Wales | |
| Austin Health | Ivanhoe | Victoria | |
| Universitair Ziekenhuis Gent | Ghent | Belgium | |
| Universitair Ziekenhuis Brussel | Jette | Belgium | |
| UZ Leuven | Leuven | Belgium | |
| Centre Hospitalier Universitaire de Liège | Liège | Belgium | |
| Centro Mineiro de Pesquisa (CMIP) | Juiz de Fora | Brazil | |
| Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre - RS | Brazil | |
| Hospital Mater Dei BA | Salvador | Brazil | |
| Hospital das Clínicas da Faculdade de Medicina da USP | São Paulo | Brazil |
+ 107 more sites — see the full list on the official registry below.
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 NCT07789015 on ClinicalTrials.gov ↗ ← All trials in China