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A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis
NCT06284954 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06284954 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06284954?
The interventions under investigation include: Empasiprubart IV (BIOLOGICAL), Placebo IV (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06284954?
This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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