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Terminated Phase 2 Interventional

Study of M5049 in DM and PM Participants (NEPTUNIA)

ClinicalTrials.gov ID: NCT05650567

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.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 10:51 AM EDT

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)

Study identification

NCT ID
NCT05650567
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
EMD Serono Research & Development Institute, Inc.
Industry
Enrollment
40 participants

Conditions and interventions

Interventions

  • M5049 high dose Drug
  • Placebo Drug

Drug

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.

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 Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05650567 live on ClinicalTrials.gov.

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