A Study to Understand How Nerandomilast Works in People With Active Idiopathic Inflammatory Myopathies
Public ClinicalTrials.gov record NCT07789015. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Parallel Design, Double-blind, Randomised, Placebo-controlled, Multi-centre Trial to Evaluate the Efficacy and Safety of Nerandomilast Oral Therapy Added to Standard Background Therapy Over 52 Weeks in Adult Trial Participants With Active Idiopathic Inflammatory Myopathies (VERANDA™-IIM)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07789015
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 270 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 14, 2026 (Estimated)
- Primary completion
- Mar 21, 2030 (Estimated)
- Completion
- Apr 4, 2030 (Estimated)
- Last update posted
- Oct 14, 2026
2026 – 2030
United States locations
- U.S. sites
- 21
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Neuromuscular Research Center | Phoenix | Arizona | 85028 | — |
| Mayo Clinic | Scottsdale | Arizona | 85259 | — |
| University of California Irvine | Irvine | California | 92697 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| University of California San Francisco | San Francisco | California | 94115 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Kansas University Medical Center | Fairway | Kansas | 66205 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109-5314 | — |
| Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Northwell Health | Great Neck | New York | 11021 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Paramount Medical Research and Consulting | Middleburg Heights | Ohio | 44130 | — |
| Oregon Health and Sciences University | Portland | Oregon | 97239 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| West Tennessee Research Institute | Jackson | Tennessee | 38305 | — |
| Helios CR, Inc - Dallas | Dallas | Texas | 75231 | — |
| Nerve and Muscle Center of Texas | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 129 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07789015, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 14, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07789015 live on ClinicalTrials.gov.