🏛️ Verified NIH Record • Updated 2026-05-19

To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva (NCT05090891)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva

🟢 Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Incyte Corporation

🩺 Plain-English Summary (8th-Grade Level)

This Phase 2, Randomized, Double-Blind, Placebo-Controlled Study is intended to evaluate the Efficacy, Safety, and Tolerability and PK of INCB000928 administered to participants with a clinical diagnosis of fibrodysplasia ossificans progressiva (FOP).

Who can join: Review the eligibility criteria below.

Location: Mayo Clinic Rochester — Rochester, Minnesota

Age range: 2 Years to 99 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (24 Sites)

  • Mayo Clinic Rochester — Rochester, Minnesota
  • Children'S Hospital of Philadelphia — Philadelphia, Pennsylvania
  • Penn Medicine - Perelman Center For Advanced Medicine — Philadelphia, Pennsylvania
  • Hospital Italiano de Buenos Aires — Buenos Aires,
  • Royal North Shore Hospital — St Leonards, New South Wales
  • Murdoch Children'S Research Institute — Parkville, Victoria
  • Albert Einstein Israelite Hospital — São Paulo,
  • University Health Network Toronto General Hospital — Toronto, Ontario
  • Centro de Estudios Reumatologicos — Santiago,
  • Beijing Childrens Hospital Capital Medical University — Beijing,
  • Tongji Hospital of Tongji University — Shanghai,
  • Shanghai Childrens Medical Center — Shanghai,
  • Childrens Hospital of Fudan University — Shanghai,
  • Ap-Hp Hopital Lariboisiere — Paris,
  • Hopital Necker-Enfants Malades — Paris,
  • Uniklinik Koln — Cologne,
  • Policlinico Universitario Agostino Gemelli Universita Cattolica Del Sacro Cuore — Rome,
  • Instituto Nacional de Rehabilitacion Luis Guillermo Ibarra — Tlalpan,
  • Amsterdam Umc - Vu Medisch Centrum (Vumc) — Amsterdam,
  • Starship Childrens Hospital — Auckland,
  • Groote Schuur Hospital Radiation Oncology — Cape Town,
  • Seoul National University Hospital — Seoul,
  • Hospital Universitario Ramon Y Cajal — Madrid,
  • Royal National Orthopaedic Hospital — Stanmore,

📞 Contact the Study Coordinator

Phone: (855) 463-3463

Email: medinfo@incyte.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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 Fibrodysplasia Ossificans Progressiva (FOP)

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗