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 | EUCTR2020-002858-24-SE (EUCTR) | 24/01/2022 | 27/11/2020 | A study assessing the efficacy and safety of an investigational drug called IPN60130 for the treatment of fibrodysplasia ossificans progressiva in participants aged 5 years of age and older | 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 progressiva in male and female participants 5 years of age and older - FALKON | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: IPN60130 10 mg capsules INN or Proposed INN: Not yet available Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2-yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate Product Name: IPN60130 50 mg capsules INN or Proposed INN: Not yet available Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2-yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate | Clementia Pharmaceuticals Inc, an Ipsen Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;Spain;Russian Federation;Colombia;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Germany;Netherlands;Japan;China;Korea, Republic of;Sweden | ||
| 2 | NCT05039515 (ClinicalTrials.gov) | December 1, 2021 | 2/9/2021 | Study to Assess the Efficacy and Safety of 2 Dosage Regimens of Oral IPN60130 for the Treatment of Fibrodysplasia Ossificans Progressiva (FOP). | 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 Progressiva in Male and Female Participants 5 Years of Age and Older. | Fibrodysplasia Ossificans Progressiva | Drug: IPN60130;Drug: Placebo | Clementia Pharmaceuticals Inc. | Ipsen | Recruiting | 5 Years | N/A | All | 90 | Phase 2 | United States;Argentina;Australia;Brazil;Canada;China;Colombia;France;Italy;Japan;Korea, Republic of;Mexico;Spain;Sweden;United Kingdom |
| 3 | EUCTR2020-002858-24-ES (EUCTR) | 19/10/2021 | 27/07/2021 | A study assessing the efficacy and safety of an investigational drug called IPN60130 for the treatment of fibrodysplasia ossificans progressiva in participants aged 5 years of age and older | 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 progressiva in male and female participants 5 years of age and older | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: IPN60130 10 mg capsules INN or Proposed INN: not yet available Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2-yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate Product Name: IPN60130 50 mg capsules INN or Proposed INN: Not yet available Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2-yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate | Clementia Pharmaceuticals Inc, an Ipsen Company | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;Spain;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of | ||
| 4 | EUCTR2020-002858-24-IT (EUCTR) | 09/06/2021 | 04/06/2021 | A study assessing the efficacy and safety of an investigational drug calledIPN60130 for the treatment of fibrodysplasia ossificans progressiva inparticipants aged 5 years of age and older | 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 progressiva in male and female participants 5 years of age and older - - | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: IPN60130 10 mg capsules Product Code: [-] Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate Product Name: IPN60130 50 mg capsules Product Code: [-] Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate | CLEMENTIA PHARMACEUTICALS INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Germany;Netherlands;China;Japan;Sweden;Korea, Republic of | ||
| 5 | EUCTR2020-002858-24-DE (EUCTR) | 27/11/2020 | A study assessing the efficacy and safety of an investigational drug called IPN60130 for the treatment of fibrodysplasia ossificans progressiva in participants aged 5 years of age and older | 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 progressiva in male and female participants 5 years of age and older | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: IPN60130 10 mg capsules INN or Proposed INN: Not yet available Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2-yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate Product Name: IPN60130 50 mg capsules INN or Proposed INN: Not yet available Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2-yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate | Clementia Pharmaceuticals Inc, an Ipsen Company | NULL | NA | Female: yes Male: yes | 90 | Phase 2 | United States;Spain;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of | |||
| 6 | EUCTR2020-002858-24-NL (EUCTR) | 08/09/2021 | A study assessing the efficacy and safety of an investigational drug called IPN60130 for the treatment of fibrodysplasia ossificans progressiva in participants aged 5 years of age and older | 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 progressiva in male and female participants 5 years of age and older | 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] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: IPN60130 10 mg capsules INN or Proposed INN: Not yet available Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2-yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate Product Name: IPN60130 50 mg capsules INN or Proposed INN: Not yet available Other descriptive name: (R)-tetrahydrofuran-3-yl 4-(6-(5-(4-ethoxy-1-isopropylpiperidin-4- yl)pyridine-2-yl)pyrrolo[1,2-b]pyridazin-4-yl)piperazine-1-carboxylate sesquisuccinate | Clementia Pharmaceuticals Inc, an Ipsen Company | NULL | NA | Female: yes Male: yes | 90 | Phase 2 | United States;Spain;Russian Federation;Colombia;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Netherlands;Germany;China;Japan;Sweden;Korea, Republic of |