274. 骨形成不全症 Osteogenesis Imperfecta Clinical trials / Disease details
臨床試験数 : 91 / 薬物数 : 101 - (DrugBank : 20) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 48
| 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 | NCT03216486 (ClinicalTrials.gov) | October 31, 2017 | 12/7/2017 | An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta | A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: BPS804 | Ultragenyx Pharmaceutical Inc | Mereo BioPharma | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 2 | NCT03118570 (ClinicalTrials.gov) | September 11, 2017 | 3/4/2017 | A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804 | Protocol Title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804). | Osteogenesis Imperfecta, Type I;Osteogenesis Imperfecta Type III;Osteogenesis Imperfecta Type IV | Drug: BPS804 | Ultragenyx Pharmaceutical Inc | NULL | Completed | 18 Years | 75 Years | All | 112 | Phase 2 | United States;Canada;Denmark;France;United Kingdom |
| 3 | EUCTR2016-005096-27-GB (EUCTR) | 25/08/2017 | 19/02/2018 | A study of test product setrusumab in adults with brittle bone syndrome. | A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804). | Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: setrusumab Product Code: BPS804 INN or Proposed INN: setrusumab Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY Trade Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product Product Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product. INN or Proposed INN: ZOLEDRONIC ACID | Mereo Biopharma 3 Ltd. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Denmark;United Kingdom | ||
| 4 | EUCTR2016-005096-27-FR (EUCTR) | 24/07/2017 | 07/02/2019 | A study of test product BPS804 compared to placebo in adults with brittle bone syndrome | A Phase 2b, Multicentre, Multinational, Placebo-controlled, Double-blind, Dose-finding Study in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with BPS804. | Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Code: BPS804 INN or Proposed INN: Not established Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY | Mereo Biopharma 3 Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United States;France;Canada;Denmark;United Kingdom | ||
| 5 | EUCTR2016-005096-27-DK (EUCTR) | 23/06/2017 | 24/03/2017 | A study of test product setrusumab in adults with brittle bone syndrome. | A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open label substudy, in Adult Patients with Type I, III or IV Osteogenesis Imperfecta Treated with setrusumab (BPS804). | Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: setrusumab Product Code: BPS804 INN or Proposed INN: setrusumab Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY Trade Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion,generic medicinal product Product Name: Zoledronic Acid Kern Pharma 4 mg/100 mL solution for infusion, generic medicinal product. INN or Proposed INN: ZOLEDRONIC ACID | Mereo BioPharma 3 Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;France;Canada;Denmark;United Kingdom | ||
| 6 | EUCTR2011-001465-41-DE (EUCTR) | 23/01/2012 | 09/08/2011 | Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfecta | A randomized, open label intra-patient dose escalation study with an untreated reference group to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple infusions of BPS804 in adults with moderate osteogenesis imperfecta - NA | Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic disorder of the connective tissue characterized by bone fragility and reduced bone mass. OI comprises a group of inherited disorders which primarily, but not always, arise from mutations in the genes encoding type I collagen. MedDRA version: 14.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: BPS804 INN or Proposed INN: NA Other descriptive name: Anti-sclerostin monoclonal antibody | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Canada;Germany | |||
| 7 | EUCTR2011-001465-41-BE (EUCTR) | 20/07/2011 | 23/05/2011 | Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfecta | A randomized, open label intra-patient dose escalation study with an untreated reference group to evaluate safety and tolerability, pharmacokinetics, and pharmacodynamics of multiple infusions of BPS804 in adults with moderate osteogenesis imperfecta - NA | Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic disorder of the connective tissue characterized by bone fragility and reduced bone mass. OI comprises a group of inherited disorders which primarily, but not always, arise from mutations in the genes encoding type I collagen. MedDRA version: 14.1;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: NA Product Code: BPS804 INN or Proposed INN: NA Other descriptive name: Anti-sclerostin monoclonal antibody | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 1;Phase 2 | Canada;Belgium;Germany | ||
| 8 | NCT01417091 (ClinicalTrials.gov) | June 2011 | 4/8/2011 | Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in Osteogenesis Imperfecta | A Randomized, Open Label Intra-patient Dose Escalation Study With an Untreated Reference Group to Evaluate Safety and Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Infusions of BPS804 in Adults With Moderate Osteogenesis Imperfecta | Osteogenesis Imperfecta | Drug: BPS804 | Ultragenyx Pharmaceutical Inc | NULL | Completed | 18 Years | 75 Years | All | 10 | Phase 2 | United States;Belgium;Canada;Germany |
| 9 | EUCTR2021-006597-23-FR (EUCTR) | 04/05/2022 | A study to test product setrusumab in subjects with brittle bone syndrome. | A Randomized, Double-Blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy and Safety of Setrusumab in Subjects with Osteogenesis Imperfecta. | Osteogenesis imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenesis imperfecta;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Setrusumab Product Code: BPS804, UX143 INN or Proposed INN: SETRUSUMAB Other descriptive name: UX143, BPS804 | Ultragenyx Pharmaceutical Inc. | NULL | NA | Female: yes Male: yes | 231 | Phase 2;Phase 3 | United States;France;Canada;Argentina;Denmark;Australia;Germany;United Kingdom;Italy |