IL‑1 blockade to reduce flares and extra bone in fibrodysplasia ossificans progressiva

An Observational Study of IL1 Inhibition for Blocking ACVR1-Induced Flare Activity and Heterotopic Ossification in Fibrodysplasia Ossificans Progressiva

NIH-funded research University of California, San Francisco · NIH-11161515

This project follows children and teens with FOP who start IL‑1 blocking medication to reduce painful flares and new extra bone growth.

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of California, San Francisco NIH-funded
Lab location1 site (San Francisco, United States)
Project IDNIH-11161515 on NIH RePORTER

What this research studies

You would join an observational program for people with severe FOP who are being started on anti‑IL‑1 therapy by their own doctor. The team will collect flare counts and patient‑reported outcomes before treatment and then continue remote monitoring after treatment starts. Eleven participants aged about 6–18 years with frequent flares (at least six per year) will be enrolled. The study uses the patients' routine clinical care decisions rather than assigning treatments, and data are captured remotely to limit travel.

Who could benefit from this research

Good fit: Children and adolescents (approximately 6–18 years old) with genetically confirmed FOP who experience frequent flares (about six or more per year) and whose clinician plans to start anti‑IL‑1 therapy are ideal candidates.

Not a fit: People who are not starting anti‑IL‑1 therapy, have mild FOP with few flares, or are outside the study age range may not benefit from participating.

Why it matters

Potential benefit: If the findings hold up, they could support using IL‑1 blocking drugs to lower flare frequency and reduce new heterotopic bone in people with FOP.

How similar studies have performed: Small preliminary reports from four FOP patients treated with anti‑IL‑1 showed large (60–90%) reductions in flare activity, but larger observational and controlled studies are still needed.

Where this research is happening

San Francisco, United States

Researchers

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page below.
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.