A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
Condition(s) studied
Investigational drug(s) / intervention(s)
Placebo: Placebo-matching nerandomilast
Nerandomilast: Nerandomilast
Study summary
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.
Eligibility
Primary outcome measure(s)
- Total improvement score (TIS) score (continuous) at Week 52 — At Week 52.
The TIS composite score includes 6 core set measures: manual muscle testing (MMT8), extra-muscular disease activity (MDAAT), patient global disease activity (PtGA), physician global disease activity (PhGA), health assessment questionnaire disability index (HAQ-DI), and muscle enzymes. An improvement score for each core set measure will be assigned using the absolute percent change, based on predetermined ranges. The TIS will be the sum of the all core set measure, scoring from 0 to 100, with higher scores corresponding to a greater degree of improvement.
Trial sites (149)
| 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 | |
| University of Pittsburgh Medical Center | Pittsburgh | 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 |
+ 109 more sites — see the full list on the official registry below.
More Boehringer Ingelheim 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 NCT07789015 on ClinicalTrials.gov ↗ ← All trials in Italy