[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibrodysplasia-ossificans-progressiva-fop\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibrodysplasia-ossificans-progressiva-fop":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,72,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100446242","phase-2-to-assess-the-efficacy-safety-and-tolerability-of-incb000928-in-participants-with-fibrodysplasia-ossificans-progressiva-100446242",false,"NCT05090891","To Assess the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva","A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva","Progress","Inclusion Criteria:\n\n* Female and male participants:\n\n  * Cohort 1: ≥ 12 years of age.\n  * Cohort 2: 6 to \\\u003C 12 years of age.\n  * Cohort 3: 2 to \\\u003C 12 years of age (after eDMC review of safety data from Cohort 2).\n* Clinical diagnosis of FOP.\n* Willingness to avoid pregnancy or fathering children based on the criteria below.\n* Willing and able to undergo low-dose WBCT (excluding the head) imaging without requiring intubation.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Pregnant or breast-feeding.\n* CAJIS score ≥ 24.\n* FOP disease severity that in the investigator's opinion precludes participation.\n* Any clinically significant medical condition other than FOP that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the participant, or interfere with interpretation of study data.\n* Chronic or current active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment.\n* HIV, HBV, or HCV infection. Note:\n* Further exclusion criteria apply.","ALL","2 Years","99 Years",{"count":21,"type":22},98,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","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).",[28],"Fibrodysplasia Ossificans Progressiva (FOP)",[30,31],"fibrodysplasia ossificans progressiva (FOP)","heterotopic ossification","RECRUITING","2026-05-19",{"date":35,"type":36},"2026-05-22","ACTUAL",{"date":38,"type":36},"2022-05-05",{"date":40,"type":22},"2033-01-20",{"name":42,"class":43},"Incyte Corporation","INDUSTRY",24,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100635963","phase-3-a-study-to-investigate-the-safety-pharmacokinetics-pk-and-efficacy-of-garetosmab-in-children-and-adolescents-with-fibrodysplasia-ossificans-progressiva-fop-100635963","NCT07559513","A Study to Investigate the Safety, Pharmacokinetics (PK), and Efficacy of Garetosmab in Children and Adolescents With Fibrodysplasia Ossificans Progressiva (FOP)","Phase 3 Evaluation of the Safety, Pharmacokinetics, and Efficacy of Garetosmab (Anti-Activin A Monoclonal Antibody) in Children and Adolescents With Fibrodysplasia Ossificans Progressiva","OPTIMA-2","Key Inclusion Criteria:\n\n1. For USA participants, age criteria are 4 to \\\u003C 18 years old, at the time of the administration of the first dose of study intervention. Non-USA participants age criteria are 2 to \\\u003C 18 years old\n2. Must have a confirmation of FOP diagnosis, as described in the protocol\n3. At the time of enrollment, participants must weight:\n\n   1. Cohort 1 \\> 30 kg\n   2. Cohort 2 \\> 30 kg\n   3. Cohort 3 ≤ 30 kg\n\nKey Exclusion Criteria:\n\n1. Cumulative Analog Joint Involvement Scale (CAJIS) score \\> 19 at the time of screening\n2. Participant has significant concomitant illness or history of significant illness, as described in the protocol\n3. Previous history or diagnosis of cancer\n4. Ongoing significant viral or bacterial illness, within 2 weeks of the first study drug administration\n5. History of severe respiratory compromise requiring oxygen, respiratory support\n6. Known history of cerebral vascular malformation\n7. Participants with a history of severe, non-traumatic bleeding requiring transfusion or hospitalization for hemodynamic compromise\n8. Participants with a known pre-existing medical history of a bleeding diathesis, as described in the protocol\n\nNOTE: Other Protocol-defined Inclusion\u002FExclusion Criteria Apply","18 Years",{"count":55,"type":22},18,[57],"PHASE3","This study is researching an experimental drug called garetosmab, referred to as \"study drug\". The study is focused on children and adolescent participants with FOP.\n\nThe aim of the study is to see how safe, tolerable, and effective the study drug is.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)",[28],[61],"Type I Activin A Receptor (ACVR1) FOP-causing mutation","NOT_YET_RECRUITING","2026-04-22",{"date":65,"type":36},"2026-04-30",{"date":67,"type":22},"2026-07-30",{"date":69,"type":22},"2029-12-21",{"name":71,"class":43},"Regeneron Pharmaceuticals",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":79,"targetDuration":81,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":120},"100266237","the-fibrodysplasia-ossificans-progressiva-fop-registry-100266237","NCT02745158","The Fibrodysplasia Ossificans Progressiva (FOP) Registry","FOP Registry: A Global Registry for the Fibrodysplasia Ossificans Progressiva Community","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of FOP.\n* Participants (or a parent or legal guardian) must be willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* There are no exclusion criteria.",{"count":80,"type":22},800,"20 Years","OBSERVATIONAL","The Fibrodysplasia Ossificans Progressiva (FOP) Registry is a global, non-interventional, voluntary database that captures demographic and disease data directly from FOP patients and their caregivers via a secure, web-based patient portal. A physician portal (in development) will allow physicians to enter clinical data about their patients. The objectives are to organize the international FOP community for participation in clinical trials; to enable FOP patients worldwide to report data in a shared forum; to improve the collective understanding of FOP natural history; and to advance the understanding of FOP treatment outcomes.",[28],[86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109],"Fibrodysplasia ossificans progressiva","FOP","International FOP Association","Patient Advocacy Group","Patient Registry","Natural History","Patient-Reported Outcomes","Observational Database","Bone Morphogenetic Protein","BMP","Bone Growth","Joint","Mobility","Flare-Up","Heterotopic Ossification","Ectopic Bone","Osteochondroma","Hallux Valgus","ALK2","ACVR1","Activin A","IFOPA","Activin A Receptor Type I","Activin Receptor-like Kinase-2","2026-04-02",{"date":112,"type":36},"2026-04-08",{"date":114,"type":36},"2015-07",{"date":116,"type":22},"2040-12-31",{"name":118,"class":119},"The International FOP Association","OTHER",1,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":128,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":132,"conditions":133,"keywords":134,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":120},"100571769","il1-inhibition-in-fop-100571769","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","6 Years","30 Years",{"count":131,"type":22},11,"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.",[28],[31,135,136,87],"canakinumab","anakinra","2026-02-27",{"date":139,"type":36},"2026-03-03",{"date":141,"type":36},"2025-04-01",{"date":143,"type":22},"2027-03",{"name":145,"class":119},"University of California, San Francisco"]