Trials / Terminated
TerminatedNCT05650567
Study of M5049 in DM and PM Participants (NEPTUNIA)
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)
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- EMD Serono Research & Development Institute, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M5049 high dose | Participants will receive film-coated tablets of M5049 at a high dose orally, twice daily up to 24 weeks. |
| DRUG | Placebo | Participants will receive placebo matched to M5049 orally, twice daily up to 24 weeks. |
Timeline
- Start date
- 2023-01-19
- Primary completion
- 2025-06-25
- Completion
- 2025-06-25
- First posted
- 2022-12-14
- Last updated
- 2025-07-17
Locations
31 sites across 7 countries: United States, Czechia, Greece, Italy, Poland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05650567. Inclusion in this directory is not an endorsement.