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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06284954
The ClinicalTrials.gov registry entry for NCT06284954 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 485-participant average among 19 other Dermatomyositis trials with a reported enrollment target (99% lower). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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