Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06284954 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
A Phase 2 study of Dermatomyositis and Myositis, sponsored by argenx.
- Active
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
- 20
- Study locations
NCT06284954: Active Phase 2 study of Dermatomyositis and Myositis, sponsored by argenx.
NCT06284954 is a Phase 2 study of Dermatomyositis and Myositis that is active but no longer recruiting, run by argenx. The registered enrollment target is 3 participants, below the 485-participant average among 19 other Dermatomyositis trials with a reported enrollment target (99% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06284954, a Phase 2 study of Dermatomyositis and Myositis, is active but no longer recruiting, sponsored by argenx.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either empasiprubart or placebo, respectively, during the treatment period (duration of 25 weeks). At the end of the treatment period, all the participants will enter a safety follow-up period (duration of 65 weeks).
Conditions Studied
Interventions
- BIOLOGICAL Empasiprubart IV
- OTHER Placebo IV
Study Locations (20)
Other
- V.Tsitlanadze Scientific Practical Reumatology Center - Tbilisi
- The First University Clinic of Tbilisi State Medical University - Tbilisi
- Institute of Clinical Cardiology, Ltd - Tbilisi
- Jerarsi Clinic - Tbilisi
- Mtskheta street Clinic - Tbilisi
- The First Medical Center - Tbilisi
- National and Kapodistrian University of Athens (NKUA) - University General Hospital Attikon - Athens
- Andreas Syggros Hospital of Skin and Venereal Diseases - University Dermatology and Venereology - Athens
- General Hospital of Thessaloniki Papageorgiou - Thessaloniki
- Azienda Ospedaliera Universitaria Pisana - Pisa
- Fondazione Policlinico Universitario Campus Bio-Medico - Rome
Florida
- Omega Research Debary, LLC - DeBary
- University of Florida Health (UF) - Endocrinology - Medical Specialties - Medical Plaza - Gainesville
- Homestead Associates in Research, Inc. - Homestead
- Life Clinical Trials - Margate
- Advance Medical Research Center - Miami
- Integral Rheumatology and Immunology Specialists (IRIS) - Plantation
- D and H Tamarac Research, LLC Center - Tamarac
California
- Profound Research LLC - Oceanside
Ohio
- Wright State Physicians Health Center - Dayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2024-08-20 |
| Est. Completion | 2026-11 |
| Phase | Phase 2 |
What the registry record for NCT06284954 still lists
NCT06284954 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 485-participant average among 19 other Dermatomyositis trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Dermatomyositis appearing as the primary indexed condition, and to 2 interventions - of which Empasiprubart IV is the first listed.
NCT06284954 names 20 study sites across 4 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT06284954 about?
NCT06284954 is a clinical study titled "A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis". This study will evaluate the safety and efficacy of empasiprubart compared with placebo in adult participants with dermatomyositis (DM). The study duration will be approximately 92 weeks for all participants. After the screening period, eligible participants will be randomized in a 2:1 ratio to rec...
What is the current status of trial NCT06284954?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2024-08-20. Estimated completion is 2026-11.
What conditions does trial NCT06284954 study?
This clinical trial studies the following conditions: Dermatomyositis, Myositis.
What interventions are being tested in trial NCT06284954?
The interventions under investigation include: Empasiprubart IV (BIOLOGICAL), Placebo IV (OTHER).
Who is sponsoring clinical trial NCT06284954?
This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06284954 being conducted?
This trial has 20 study locations across California, Florida, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dermatomyositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06284954's enrollment target sits among peer trials
3 20th of 19 the lowest of 19 other Dermatomyositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dermatomyositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy
RECRUITING · Phase 2
-
Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis
RECRUITING · Phase 2
-
Intralesional Injection of STS in Treatment of Calcinosis
RECRUITING · Phase 2
-
A Study Evaluating the Effects of GLPG3667 Given as Oral Treatment for up to 24 Weeks in Adults With Dermatomyositis
ACTIVE NOT RECRUITING · Phase 2
-
A Study to Investigate the Efficacy and Safety of Efgartigimod PH20 SC in Adult Participants With Active Idiopathic Inflammatory Myopathy.
ACTIVE NOT RECRUITING · Phase 2
-
Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI