A Study to Evaluate Safety and Efficacy of Empasiprubart in Adults With Dermatomyositis (NCT06284954)
A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart in Adults With Dermatomyositis
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Profound Research LLC — Oceanside, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (28 Sites)
Showing the first 25 of 28 sites.
- Profound Research LLC — Oceanside, California
- Omega Research Debary, LLC — DeBary, Florida
- University of Florida Health (UF) - Endocrinology - Medical Specialties - Medical Plaza — Gainesville, Florida
- Homestead Associates in Research, Inc. — Homestead, Florida
- Life Clinical Trials — Margate, Florida
- Advance Medical Research Center — Miami, Florida
- Integral Rheumatology and Immunology Specialists (IRIS) — Plantation, Florida
- D and H Tamarac Research, LLC Center — Tamarac, Florida
- Wright State Physicians Health Center — Dayton, Ohio
- 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,
- Timofei Mosneaga Republican Clinical Hospital — Chisinau,
- Institute of Cardiology — Chisinau,
- Nova Reuma Domyslawska i Rusilowicz- Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty — Bialystok,
- Prywatna Praktyka Lekarska Prof. UM dr Hab. Med. Pawel Hrycaj — Poznan,
- Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu — Wroclaw,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Dermatomyositis
- A Study to Investigate the Efficacy and Safety of Brepocitinib in Adults With Dermatomyositis — Phoenix, Arizona
- Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis — Palo Alto, California
- Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis — Cleveland, Ohio
- Adult and Juvenile Myositis — Atlanta, Georgia
- Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) — Philadelphia, Pennsylvania
Explore by condition: All Dermatomyositis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.