Actively Recruiting
IL1 Inhibition in FOP
Led by University of California, San Francisco · Updated on 2026-03-03
11
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
N
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
IL1 Inhibition in FOP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with classical FOP confirmed by clinical presentation and ACVR1R206H genetic variant, aged 6 to 30 years
- Patients with severe FOP disease activity defined by more than 4 flares per year or a flare lasting over 1 month
- Patients recommended by their medical team to start anti-IL1 therapy
- Ability to participate in all study assessments including blood draws, imaging, and travel
- No history of unexplained infections, autoimmune disease, or contraindication to anti-IL1 therapy
- Written informed consent and ability to comply with study requirements
You will not qualify if you...
- Pregnant or breastfeeding, or unwilling to use birth control during the study
- Any condition that may compromise patient safety or data quality as judged by the investigator
- Unable to travel to the study site for assessments
- Pre-existing autoimmune or autoinflammatory diseases other than FOP
- Unable to tolerate study assessments such as blood draws
- History of unexplained infections
- Currently participating in an interventional trial or using disease-modifying medications
- Unable to take medications as prescribed by their physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCSF
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
S
Samantha Klein
CONTACT
J
Judy Gonzalez-Vargas
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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