272. 進行性骨化性線維異形成症 Fibrodysplasia ossificans progressiva Clinical trials / Disease details
臨床試験数 : 39 / 薬物数 : 38 - (DrugBank : 7) / 標的遺伝子数 : 27 - 標的パスウェイ数 : 95
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2016-002526-36-FR (EUCTR) | 05/07/2022 | 04/07/2016 | Study of an Investigational Drug, Palovarotene, in the prevention of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 2, Open-Label, Efficacy and Safety Study of an RAR?-Specific Agonist (Palovarotene) to Prevent Heterotopic Ossification in Subjects with Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossification (HO) in muscles, tendons, and ligaments. Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. Prognosis is poor and median life expectancy is 40 years. MedDRA version: 19.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: Palovarotene INN or Proposed INN: Palovarotene Other descriptive name: Palovarotene | Clementia Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 17 | Phase 2 | France | ||
| 2 | NCT05027802 (ClinicalTrials.gov) | March 14, 2022 | 25/8/2021 | A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years With Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. | 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 Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit From Palovarotene Therapy. | Fibrodysplasia Ossificans Progressiva (FOP) | Drug: Palovarotene | Ipsen | NULL | Recruiting | 14 Years | N/A | All | 87 | Phase 3 | United States;Argentina;Australia;Canada;France;Italy;Sweden;United Kingdom |
| 3 | NCT04829773 (ClinicalTrials.gov) | January 3, 2019 | 1/4/2021 | Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects | An Open-Label Study Evaluating the Effect of Food on the Pharmacokinetics of Palovarotene and the Effect of Palovarotene on the Pharmacokinetics of the CYP3A4 Substrate Midazolam in Two Cohorts of Healthy Adult Subjects | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene;Drug: midazolam | Clementia Pharmaceuticals Inc. | NULL | Completed | 18 Years | 55 Years | All | 48 | Phase 1 | United States |
| 4 | EUCTR2017-002541-29-NL (EUCTR) | 16/07/2018 | 06/02/2018 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc | NULL | NA | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden | ||
| 5 | EUCTR2017-002541-29-IT (EUCTR) | 15/03/2018 | 26/01/2021 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: not applicable Product Name: PALOVAROTENE Product Code: not assigned INN or Proposed INN: Palovarotene Other descriptive name: PALOVAROTENE Trade Name: not applicable Product Name: PALOVAROTENE 1.5 mg Product Code: [not applicable] INN or Proposed INN: PALOVAROTENE Other descriptive name: Palovarotene Trade Name: not applicable Product Name: PALOVAROTENE-2 mg Product Code: [not assigned] INN or Proposed INN: PALOVAROTENE Other descriptive name: Palovarotene Trade Name: not applicable Product Name: PALOVAROTENE Product Code: [not applicable] INN or Proposed INN: PALOVAROTENE Other descriptive name: palovarotene Trade Name: not applicable Product Name: PALOVAROTENE-3 mg Product Code: [not applicable] INN or Proposed INN: PALOVAROTENE Other descriptive name: Palovarotene Trade Name: not applicable Product Name: PALOVAROTENE-4 mg | CLEMENTIA PHARMACEUTICALS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 107 | Phase 3 | United States;Spain;Korea, Democratic People's Republic of;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 6 | EUCTR2017-002541-29-GB (EUCTR) | 14/12/2017 | 11/09/2017 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 107 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;Germany;Netherlands;Japan;Sweden | ||
| 7 | EUCTR2017-002541-29-SE (EUCTR) | 05/12/2017 | 20/09/2017 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 107 | Phase 3 | Argentina;United States;Japan;United Kingdom;Spain;Canada;Sweden;Netherlands;Brazil;Italy;Australia;France;Germany | ||
| 8 | NCT03312634 (ClinicalTrials.gov) | November 30, 2017 | 9/10/2017 | An Efficacy and Safety Study of Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva. | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene | Clementia Pharmaceuticals Inc. | NULL | Completed | 4 Years | N/A | All | 107 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;France;Italy;Japan;Spain;Sweden;United Kingdom |
| 9 | EUCTR2017-002541-29-ES (EUCTR) | 14/11/2017 | 28/09/2017 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden | ||
| 10 | NCT02521792 (ClinicalTrials.gov) | December 7, 2015 | 6/8/2015 | In-Home Evaluation of Episodic Administration of Palovarotene in Fibrodysplasia Ossificans Progressiva (FOP) Subjects | A Phase 2, In-Home, Safety and Efficacy Evaluation of Episodic Administration of Open-Label Palovarotene in Subjects With Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene | Clementia Pharmaceuticals Inc. | NULL | Terminated | 6 Years | 65 Years | All | 6 | Phase 2 | United States;France;United Kingdom |
| 11 | EUCTR2014-002496-28-GB (EUCTR) | 13/11/2015 | 04/09/2015 | Extension Study of an Investigational Drug, Palovarotene, in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossification (HO) in muscles, tendons, and ligaments. Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. Prognosis is poor and median life expectancy is 40 years. MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: Palovarotene INN or Proposed INN: Palovarotene Other descriptive name: Palovarotene | Clementia Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | United States;Argentina;Australia;United Kingdom | ||
| 12 | EUCTR2014-001453-17-GB (EUCTR) | 07/07/2015 | 25/02/2015 | The Study of an Investigational Drug, Palovarotene, in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva. | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP). | Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossification (HO) in muscles, tendons, and ligaments. Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. Prognosis is poor and median life expectancy is 40 years. MedDRA version: 18.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: Palovarotene INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE Product Name: Palovarotene Product Code: Palovarotene INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;Argentina;United Kingdom | ||
| 13 | NCT02279095 (ClinicalTrials.gov) | October 27, 2014 | 26/10/2014 | An Open-Label Extension Study of Palovarotene Treatment in Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 2, Open-Label Extension, Efficacy and Safety Study of a Retinoic Acid Receptor Gamma (RAR?) Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene dose level 1;Drug: Palovarotene dose level 2;Drug: Palovarotene dose level 3;Drug: Palovarotene dose level 4 | Clementia Pharmaceuticals Inc. | NULL | Completed | 6 Years | 65 Years | All | 54 | Phase 2 | United States;Argentina;Australia;France;United Kingdom |
| 14 | NCT02190747 (ClinicalTrials.gov) | July 2014 | 13/7/2014 | An Efficacy and Safety Study of Palovarotene to Treat Preosseous Flare-ups in FOP Subjects | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects With Fibrodysplasia Ossificans Progressiva (FOP) | Fibrodysplasia Ossificans Progressiva | Drug: Palovarotene;Drug: Placebo | Clementia Pharmaceuticals Inc. | NULL | Completed | 6 Years | N/A | All | 40 | Phase 2 | United States;France;United Kingdom |
| 15 | EUCTR2014-002496-28-Outside-EU/EEA (EUCTR) | 15/07/2021 | Extension Study of an Investigational Drug, Palovarotene, in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 2, Open-Label Extension, Efficacy and Safety Study of a RAR?-Specific Agonist (Palovarotene) in the Treatment of Preosseous Flare-ups in Subjects with Fibrodysplasia Ossificans Progressiva (FOP). | Fibrodysplasia Ossificans Progressiva (FOP) is a rare, severely disabling disease characterized by painful, recurrent episodes of soft tissue swelling (flare-ups) and abnormal heterotopic ossification (HO) in muscles, tendons, and ligaments. Lesions begin in early childhood and lead to progressive ankyloses of major joints with resultant loss of movement. Prognosis is poor and median life expectancy is 40 years. MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene INN or Proposed INN: Palovarotene Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | Phase 2 | Australia;United States;Argentina | ||||
| 16 | EUCTR2017-002541-29-Outside-EU/EEA (EUCTR) | 15/07/2021 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP). - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE INN or Proposed INN: Palovarotene Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc. | NULL | NA | Female: yes Male: yes | Phase 3 | Australia;Brazil;Canada;Japan;United States;Argentina | ||||
| 17 | EUCTR2017-002541-29-FR (EUCTR) | 20/10/2017 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc | NULL | NA | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden | |||
| 18 | EUCTR2021-002244-70-IT (EUCTR) | 23/11/2021 | A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged >=14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. | 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 Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit from Palovarotene Therapy. - PIVOINE | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: [IPN60120] INN or Proposed INN: Palovarotene Trade Name: IDROCORTISONE ACETATO DYNACREN - 1 % CREMA 1 TUBO DA 30 G Product Name: IDROCORTISONE ACETATO DYNACREN 1% CREMA Product Code: [-] INN or Proposed INN: ACIDO FUSIDICO/IDROCORTISONE ACETATO | IPSEN PHARMA SAS | NULL | NA | Female: yes Male: yes | 87 | Phase 3 | United States;France;Canada;Argentina;Spain;Brazil;Australia;United Kingdom;Italy;Sweden | |||
| 19 | EUCTR2017-002541-29-DE (EUCTR) | 29/09/2017 | A clinical trial to evaluate the Efficacy and Safety of Oral Palovarotene as a treatment for Fibrodysplasia Ossificans Progressiva (FOP) | A Phase 3, Efficacy and Safety Study of Oral Palovarotene for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP) - MOVE Trial | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: PALOVAROTENE - 1mg INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE Product Name: PALOVAROTENE - 1.5mg INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE Product Name: PALOVAROTENE - 2 mg INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE Product Name: PALOVAROTENE - 2.5 mg INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE Product Name: PALOVAROTENE - 3 mg INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE Product Name: PALOVAROTENE - 4 mg INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE Product Name: PALOVAROTENE - 5 mg INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE Product Name: PALOVAROTENE - 10 mg INN or Proposed INN: PALOVAROTENE Other descriptive name: PALOVAROTENE | Clementia Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Australia;South Africa;Netherlands;Germany;Japan;Sweden | |||
| 20 | EUCTR2021-002244-70-FR (EUCTR) | 09/11/2021 | A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. | 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 Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit from Palovarotene Therapy. - PIVOINE | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: IPN60120 INN or Proposed INN: Palovarotene Other descriptive name: PALOVAROTENE | Ipsen Pharma SAS | NULL | NA | Female: yes Male: yes | 87 | Phase 3 | United States;France;Canada;Argentina;Spain;Brazil;Australia;United Kingdom;Italy;Sweden | |||
| 21 | EUCTR2021-002244-70-SE (EUCTR) | 25/10/2021 | A Rollover Study to Further Evaluate the Safety and Efficacy of Palovarotene Capsules in Male and Female Participants Aged =14 Years with Fibrodysplasia Ossificans Progressiva (FOP) Who Have Completed the Relevant Parent Studies. | 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 Ossificans Progressiva (FOP) Who Have Completed Study PVO-1A-301 or PVO-1A-202/PVO-1A-204 and May Benefit from Palovarotene Therapy. - PIVOINE | Fibrodysplasia Ossificans Progressiva (FOP) MedDRA version: 20.0;Level: PT;Classification code 10068715;Term: Fibrodysplasia ossificans progressiva;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Palovarotene Product Code: IPN60120 INN or Proposed INN: Palovarotene Other descriptive name: PALOVAROTENE | Ipsen Pharma | NULL | NA | Female: yes Male: yes | 61 | Phase 3 | France;United States;Canada;Argentina;Spain;Brazil;Australia;United Kingdom;Italy;Sweden |