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 : 40 / 薬物数 : 36 - (DrugBank : 6) / 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 | EUCTR2016-005035-33-ES (EUCTR) | 17/01/2019 | 22/01/2019 | A study to examine the safety, tolerability and effects on abnormal bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva | A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 | 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: REGN2477 Product Code: REGN2477 INN or Proposed INN: N/A Other descriptive name: REGN2477 | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | United States;France;Mexico;Canada;Poland;Spain;Netherlands;Colombia;United Kingdom;Italy | ||
| 2 | EUCTR2016-005035-33-NL (EUCTR) | 05/03/2018 | 04/07/2017 | A study to examine the safety, tolerability and effects on abnormal bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva | A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 | 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: REGN2477 Product Code: REGN2477 INN or Proposed INN: N/A Other descriptive name: REGN2477 | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;United States;Argentina;Spain;Brazil;Netherlands;United Kingdom;Italy | ||
| 3 | NCT03188666 (ClinicalTrials.gov) | February 26, 2018 | 13/6/2017 | A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva | A Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effects on Heterotopic Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva | Fibrodysplasia Ossificans Progressiva | Drug: REGN2477;Drug: Matching placebo | Regeneron Pharmaceuticals | NULL | Completed | 18 Years | 60 Years | All | 44 | Phase 2 | United States;Canada;France;Italy;Netherlands;Poland;Spain;United Kingdom;Colombia |
| 4 | EUCTR2016-005035-33-IT (EUCTR) | 15/12/2017 | 08/03/2018 | A study to examine the safety, tolerability and effects on abnormal bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva | A randomized, placebo-controlled study to assess the safety, tolerability,pharmacokinetics, and effects on heterotopic bone formation of REGN2477in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 | 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: REGN2477 Product Code: REGN2477 Other descriptive name: REGN2477 | REGENERON PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | France;United States;Argentina;Brazil;Netherlands;United Kingdom;Italy | ||
| 5 | EUCTR2016-005035-33-GB (EUCTR) | 15/08/2017 | 22/05/2017 | A study to examine the safety, tolerability and effects on abnormal bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva | A randomized, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and effects on heterotopic bone formation of REGN2477 in patients with Fibrodysplasia Ossificans Progressiva - LUMINA-1 | 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: REGN2477 Product Code: REGN2477 INN or Proposed INN: N/A Other descriptive name: REGN2477 | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;France;Mexico;Canada;Spain;Poland;Netherlands;Colombia;Italy;United Kingdom |