[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571769":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":28,"centralContacts":32,"locations":42,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":10,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,14,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-IL1 Observational Arm",null,"FOP patients that are beginning treatment with Anti-IL1 Therapy",[13],"Other: Anti-IL1 Therapy",{"label":15,"type":10,"description":16,"interventionNames":10},"Optional Non-Treatment Observational Arm","FOP patients unable to obtain Anti-IL1 therapy",{"label":18,"type":10,"description":19,"interventionNames":10},"\"On Treatment\" Observational Arm","FOP patients that are already using Anti-IL1 therapy",[21],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"Anti-IL1 Therapy","Anti-IL1 is a rescue therapy for FOP patients that is hypothesized to reduce flare activity and subsequent ossification in these patients",[9],[26,27],"Canakinumab","Anakinra",[29],{"name":30,"affiliation":5,"role":31},"Edward Hsiao, MD, PhD","PRINCIPAL_INVESTIGATOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":10,"email":37},"Samantha Klein","CONTACT","415-254-5748","Samantha.klein@ucsf.edu",{"name":39,"role":35,"phone":40,"phoneExt":10,"email":41},"Judy Gonzalez-Vargas","415-254-5048","Judy.Gonzalez-Vargas@ucsf.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"UCSF","RECRUITING","San Francisco","California","94143","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.41942,37.77493,{"lat":55,"lon":54},[58],{"name":30,"role":35,"phone":59,"phoneExt":10,"email":60},"415-476-9732","edward.hsiao@ucsf.edu",{"type":62,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[64],{"name":65,"class":66},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH","100571769","il1-inhibition-in-fop-100571769",false,"NCT06724562","IL1 Inhibition in FOP","An Observational Study of IL1 Inhibition for Blocking ACVR1-Induced Flare Activity and Heterotopic Ossification in Fibrodysplasia Ossificans Progressiva (FOP)","Inclusion Criteria:\n\n* Patients with a clinical presentation consistent with FOP and a genetic diagnosis of classical FOP (ACVR1R206H variant) (2), male or female aged 6-30 years old.\n* Patients with unusually severe FOP disease activity. This will be determined by FOP flare frequency of \\>4 flares per year, which is 2 times higher than the reported average in prior FOP studies ; or by a persistent flare that has failed to resolve after 1 month of standard-of-care therapy.\n* Patients whose primary medical team has decided that rescue therapy with an anti-IL1 medication should be initiated. Once the primary medical team has decided that anti-IL1 therapy should be pursued, the subject will be told about this clinical-observational study and enrolled in the pre-treatment phase while access to the anti-IL1 therapy is being obtained by the clinical management team.\n* Ability to participate in all assessments, including blood draws, radiology assessments, and travel. Age 6 is chosen as the lower limit to avoid the need for anesthesia for whole body CT in younger subjects.\n* No history of unexplained infections, known autoimmune disease, or contraindication to anti-IL1 therapy.\n* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n* Inability to travel to site for assessments\n* Pre-existing autoimmune or autoinflammatory disease (aside from FOP)\n* Inability to tolerate assessments (such as phlebotomy)\n* Unexplained infections\n* Current participation in an interventional trial, or study of a potentially disease modifying medication\n* Inability to take medications as prescribed by managing physician","ALL","6 Years","30 Years",{"count":78,"type":79},11,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.",[83],"Fibrodysplasia Ossificans Progressiva (FOP)",[85,86,87,88],"heterotopic ossification","canakinumab","anakinra","FOP","2026-02-27",{"date":91,"type":92},"2026-03-03","ACTUAL",{"date":94,"type":92},"2025-04-01",{"date":96,"type":79},"2027-03",{"name":5,"class":6},1]