IL1 Inhibition in FOP

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06724562
Status
Recruiting
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Conditions

  • Fibrodysplasia Ossificans Progressiva (FOP)

Eligibility Criteria

Sex
ALL
Age
6 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Anti-IL1 Therapy — OTHER
    Anti-IL1 is a rescue therapy for FOP patients that is hypothesized to reduce flare activity and subsequent ossification in these patients

Study Details

This is an observational pre-post study to observe if the off label use of anti-IL1 therapies, such as anakinra or canakinumab, can block ACVR1-induced flare activity and heterotopic ossification in FOP. It will also generate key tools and preliminary data that are needed to design a future Phase II study. This study specifically focuses on patients with severe FOP who are being considered by their medical team for rescue therapy with anti-IL1 therapy. Preliminary data suggests patients experience significant decreases in flare frequency when taking anti-IL1 therapy, but other measures of efficacy remain unassessed, such as changes in heterotopic ossification formation, changes in pain medication use, and changes in functionality.

Key Dates

Start date
Apr 1, 2025
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
11 participants (estimated)

Arms

  • Arm: Anti-IL1 Observational Arm
    FOP patients that are beginning treatment with Anti-IL1 Therapy
  • Arm: Optional Non-Treatment Observational Arm
    FOP patients unable to obtain Anti-IL1 therapy
  • Arm: "On Treatment" Observational Arm
    FOP patients that are already using Anti-IL1 therapy

Primary Outcome Measure

Number of flares that a patient experiences. [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSFSan FranciscoCalifornia94143
Edward Hsiao, MD, PhD
[email protected]
415-476-9732

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By research site
UCSF· San Francisco, CA

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