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Clinical Trials in China / NCT07789015
Starting soon Phase 3

A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies

NCT07789015 · tracked via the Priya Life Science China tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2026-11-09
Last updated
2026-09-16

Condition(s) studied

Idiopathic Inflammatory Myopathies

Investigational drug(s) / intervention(s)

PlaceboNerandomilast

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion criteria: 1. Male or female adult individuals from ≥18 years of age (or alternative age for adults based on local regulations) on the date of signing the informed consent. 2. A definite or probable clinical diagnosis of idiopathic inflammatory myopathy (IIM) according to the 2017 American college of rheumatology (ACR)/European alliance of associations of rheumatology (EULAR) classification criteria. 3. Participants with overlap myositis (OM) must have IIM as the predominant disease. 4. Participants ≥18 years of age (or alternative age for adults based on local regulations) with juvenile dermatomyositis (JDM) can only be included if they were 15 years old or older at first onset of DM symptoms. 5. Disease activity defined by moderate to severe myopathy. 6. The participant must be on background therapy for IIM. 7. Woman (or women) of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control for a period of 28 days before treatment initiation, throughout the trial, and for a period of at least 5 days after the last dose of investigational medicinal product (IMP). WOCBP taking oral contraceptives also have to use one barrier method. 8. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 9. Further inclusion criteria apply. Exclusion criteria: 1. Major surgery (major according to the investigator's assessment, e.g. hip replacement) performed within 6 weeks prior to randomisation or planned during the trial period. 2. Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin, or in situ squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix. 3. Participants who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial. 4. Participants diagnosed with advanced interstitial lung disease (ILD). 5. Severe muscle damage. 6. Further exclusion criteria apply.

Primary outcome measure(s)

Trial sites (147)

FacilityCityRegionStatus
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.

More Boehringer Ingelheim trials in China

Other trials for the same condition

Official registry record

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