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Clinical trials for FOP

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: FOP. Displaying page 1 of 1.
    EudraCT Number: 2021-002286-17 Sponsor Protocol Number: INCB00928-201 Start Date*: 2022-04-19
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of INCB000928 in Participants With Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodysplasia ossificans progressiva
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) NL (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-002541-29 Sponsor Protocol Number: PVO-1A-301 Start Date*: 2017-12-14
    Sponsor Name:Clementia Pharmaceuticals Inc
    Full Title: A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Completed) ES (Ongoing) DE (Completed) FR (Completed) NL (Ongoing) IT (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-001453-17 Sponsor Protocol Number: PVO-1A-201 Start Date*: 2015-07-07
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia O...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    18.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2016-005035-33 Sponsor Protocol Number: R2477-FOP-1623 Start Date*: 2017-08-15
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progres...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) NL (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-002244-70 Sponsor Protocol Number: CLIN-60120-452 Start Date*: Information not available in EudraCT
    Sponsor Name:Ipsen Pharma SAS
    Full Title: Rollover Study; Multicentre, Phase III, Open-label Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged ≥14 Years with Fibrodysplasia Ossi...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FR (Completed) IT (Completed) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2022-000880-40 Sponsor Protocol Number: R2477-FOP-2175 Start Date*: 2022-08-29
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: Phase 3 Randomized, Placebo-Controlled Study to Assess Safety, Tolerability, and Efficacy of Garetosmab in Patients with Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodysplasia Ossificans Progressiva
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) FI (Trial now transitioned) IT (Trial now transitioned) NL (Ongoing) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-002496-28 Sponsor Protocol Number: PVO-1A-202 Start Date*: 2015-11-13
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RARγ-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva ...
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-003324-20 Sponsor Protocol Number: STOPFOP1 Start Date*: 2020-01-08
    Sponsor Name:VU University Medical Center
    Full Title: Saracatinib trial TO Prevent FOP
    Medical condition: Fibrodyplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-002526-36 Sponsor Protocol Number: PVO-1A-204 Start Date*: 2022-07-05
    Sponsor Name:Clementia Pharmaceuticals Inc.
    Full Title: A Phase 2, Open-Label, Efficacy and Safety Study of an RARγ-Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects with Fibrodysplasia Ossificans Progressiva (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossificat...
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2011-002516-85 Sponsor Protocol Number: 01-2011 Start Date*: 2011-10-20
    Sponsor Name:A.O. UNIVERSITARIA INTEGRATA DI VERONA
    Full Title: Open-label study to evaluate the efficacy and tolerability of orally administered rosiglitazone in patients with progressive bone Fibrodysplasia (FOP)
    Medical condition: Fibrodysplasia Ossificans Progressive (FOP) is a rare genetically based disability, characterized by progressive heterotopic ossification, usually associated with congenital malformation of the toes.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10028393 Musculoskeletal and connective tissue disorders NEC HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-002858-24 Sponsor Protocol Number: D-CA-60130-452 Start Date*: 2021-12-17
    Sponsor Name:Clementia Pharmaceuticals Inc, an Ipsen Company
    Full Title: A Phase 2, two-part, placebo-controlled, parallel-group, double-blind study to assess the efficacy and safety of 2 dosage regimens of oral IPN60130 for the treatment of fibrodysplasia ossificans pr...
    Medical condition: fibrodysplasia ossificans progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Ongoing) SE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) BE (Trial now transitioned) PT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-000692-39 Sponsor Protocol Number: IVY Start Date*: 2023-06-19
    Sponsor Name:Amsterdam University Medical Center
    Full Title: Safety, tolerability and immunogenicity of intradermal mRNA SARS-CoV2 vaccination in patients with Fibrodysplasia Ossificans Progressiva
    Medical condition: Fibrodyplasia Ossificans Progressiva (FOP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10068715 Fibrodysplasia ossificans progressiva PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2005-005026-31 Sponsor Protocol Number: EFC6125 [AVE0005A/3001] Start Date*: 2006-04-24
    Sponsor Name:Sanofi-Synthelabo Recherche, a subsidiary of sanofi-aventis group
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Effect of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients with ...
    Medical condition: pacientes con cáncer de ovario avanzado con ascitis maligna sintomática recurrente
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: ES (Completed) GB (Completed) HU (Completed) AT (Prematurely Ended) BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000604-16 Sponsor Protocol Number: ARD6772 Start Date*: 2006-08-30
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A Multicenter, Open-Label, Single-Arm Study of Intravenous AVE0005 (VEGF Trap) Administered Every 2 Weeks in Advanced Ovarian Cancer Patients with Recurrent Symptomatic Malignant Ascites.
    Medical condition: Advanced ovarian cancer patients with recurrent symptomatic malignant ascites.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000110-19 Sponsor Protocol Number: P060406 Start Date*: 2012-01-10
    Sponsor Name:Assistance Publique – Hôpitaux de Paris (AP-HP)
    Full Title: Closure of patent foramen ovale or anticoagulants versus antiplatelet therapy to prevent stroke recurrence
    Medical condition: The study compares different strategies for secondary stroke (or retinal ischaemia) prevention in patients with patent foramen ovale. The three treatment arms comprise: 1. Endovascular patent f...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10036654 Prevention LLT
    19.0 100000004850 10016982 Foramen ovale patent LLT
    19.0 100000004852 10042244 Stroke LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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