Phase 3 study · Boehringer Ingelheim · NCT07789015
Boehringer Ingelheim's phase 3 nerandomilast study for myositis
About 270 adults are planned, and each is picked by chance to take nerandomilast or placebo tablets twice a day for 1 year. The tablets are added to each person's usual myositis treatment, and neither participants nor study doctors know which they get.
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Hear when Boehringer Ingelheim's phase 3 nerandomilast study opens near you
One email when it starts enrolling or lists a new site, with the sites and how to reach the study team. Nothing else.
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Check the main requirements privately
These questions restate the study's public listing in plain words. Your answers stay on this device and are never sent. You can print a one-page summary to go over with your rheumatologist.
1. Are you 18 or older?
2. Has a doctor diagnosed you with idiopathic inflammatory myopathy, also called myositis?
The listing names the 2017 ACR/EULAR classification criteria, and your rheumatologist can say whether your diagnosis meets them.3. Is your myositis active now, with moderate to severe muscle disease?
The listing does not say how this is measured, and the study team checks it.4. Are you on a treatment for your myositis right now?
The listing's full title says nerandomilast or placebo is added to standard background therapy.5. Did dermatomyositis symptoms first start for you before age 15?
6. Has a doctor diagnosed you with advanced interstitial lung disease (ILD)?
7. Have you had major surgery, such as a hip replacement, in the past 6 weeks, or do you have major surgery planned during the study?
The listing says the study doctor decides what counts as major surgery.The study team also checks for these, which are easier to go over with your rheumatologist:
- For overlap myositis, myositis must be the main disease
- Severe muscle damage
- Active or suspected cancer, or cancer in the past 5 years, apart from appropriately treated basal cell skin cancer, in situ squamous cell skin cancer or in situ cervical cancer
- Needing or wanting to keep taking a restricted medicine, or any drug likely to interfere with the study's safety
- Highly effective birth control for women who could become pregnant, from 28 days before treatment until at least 5 days after the last dose
- More inclusion and exclusion rules in the full study protocol, which the public listing does not spell out
Sites and contact
US sites from the public ClinicalTrials.gov record, refreshed every hour. Only the study team decides who can join.
- Arizona Neuromuscular Research CenterPhoenix, Arizona
- Mayo ClinicScottsdale, Arizona
- University of California IrvineIrvine, California
- University of California Los AngelesLos Angeles, California
- University of California San FranciscoSan Francisco, California
- University of Colorado DenverAurora, Colorado
- Kansas University Medical CenterFairway, Kansas
- Johns Hopkins HospitalBaltimore, Maryland
- Brigham and Women's HospitalBoston, Massachusetts
- University of MichiganAnn Arbor, Michigan
- Mayo Clinic, RochesterRochester, Minnesota
- Washington University School of MedicineSt Louis, Missouri
- Northwell HealthGreat Neck, New York
- Cleveland ClinicCleveland, Ohio
- Paramount Medical Research and ConsultingMiddleburg Heights, Ohio
- Oregon Health and Sciences UniversityPortland, Oregon
- University of PennsylvaniaPhiladelphia, Pennsylvania
- University of Pittsburgh Medical CenterPittsburgh, Pennsylvania
- West Tennessee Research InstituteJackson, Tennessee
- Helios CR, Inc - DallasDallas, Texas
- Nerve and Muscle Center of TexasHouston, Texas
Every site's own contact and the full eligibility list are on the official ClinicalTrials.gov listing for NCT07789015.
Questions people ask about Boehringer Ingelheim's phase 3 nerandomilast study
Is Boehringer Ingelheim's phase 3 nerandomilast study enrolling now?
ClinicalTrials.gov lists it as not yet recruiting, as of its last update there on 2026-10-29. Follow it on this page to get one email when it opens or adds US sites.
Where are the US sites for Boehringer Ingelheim's phase 3 nerandomilast study?
The listing names 21 US sites, in Arizona, California, Colorado, Kansas, Maryland, Massachusetts and 9 other states. The full list is in the sites section of this page.
Who can join Boehringer Ingelheim's phase 3 nerandomilast study?
About 270 adults are planned, and each is picked by chance to take nerandomilast or placebo tablets twice a day for 1 year. The main listed requirements are in the pre-check on this page, starting with: adults 18 and older on the date of signing consent, or the adult age set by local rules. Only the study team decides who can join.
How do I contact the Boehringer Ingelheim's phase 3 nerandomilast study team?
The listing names this contact: Boehringer Ingelheim, 1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com. Each site may also list its own contact on ClinicalTrials.gov.
Is Trial Friend part of this study?
No. Trial Friend is independent of this study and its sponsor, Boehringer Ingelheim. This page restates the public listing in plain words, and nothing here is medical advice; talk with your rheumatologist about whether a study is right for you.
From the public ClinicalTrials.gov record NCT07789015, last updated there 2026-10-29. Questions checked against the listing on November 10, 2026. Trial Friend is independent of this study and its sponsor, and is not a medical provider. Nothing here is medical advice; talk with your rheumatologist about whether a study is right for you.