Study of M5049 in DM and PM Participants (NEPTUNIA)
Public ClinicalTrials.gov record NCT05650567. 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 IIa, Randomized, Parallel, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Enpatoran in Dermatomyositis and Polymyositis Participants Receiving Standard of Care (NEPTUNIA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate the efficacy and safety of orally administered M5049 in idiopathic inflammatory myopathies, specifically dermatomyositis (DM) and polymyositis (PM) participants for 24 weeks.
Study identification
- NCT ID
- NCT05650567
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- 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
- Jan 18, 2023
- Primary completion
- Jun 24, 2025
- Completion
- Jun 24, 2025
- Last update posted
- Jul 16, 2025
2023 – 2025
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Neuromuscular Research Center | Phoenix | Arizona | 85028 | — |
| HonorHealth Research Institute - Bob Bove Neuroscience Institute-Neuroscience Research | Scottsdale | Arizona | 85251 | — |
| Mayo Clinic Scottsdale (6365) | Scottsdale | Arizona | 85259 | — |
| Barbara Davis Center | Aurora | Colorado | 80045 | — |
| HMD Research LLC | Orlando | Florida | 32819 | — |
| Bolanos Clinical Research | Pembroke Pines | Florida | 33026 | — |
| Augusta University-Rheumatology | Augusta | Georgia | 30912 | — |
| Johns Hopkins University - Department of Medicine, Division of Rheumatology | Baltimore | Maryland | 21224 | — |
| University of Minnesota-Dermatology | Minneapolis | Minnesota | 55455 | — |
| University of Kansas Medical Center-Neuromuscular | Kansas City | Missouri | 66103 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| Austin Neuromuscular Center | Austin | Texas | 78759 | — |
| Nerve and Muscle Center of Texas-Clinical research | 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 18 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05650567, 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 Jul 16, 2025 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05650567 live on ClinicalTrials.gov.