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
Showing 1 to 9 of 9 diseases
| 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 An Exploratory Study of BPS804Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperf ... | A Phase 2, Non-controlled, Open-Label, 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 BPS804Treatment in Adult Patients With T ... | Osteogenesis Imperfecta | Drug: BPS804 | Ultragenyx Pharmaceutical Inc | Mereo BioPharma | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |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). Protocol Title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporat ... | 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). A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open labe ... | 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] Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ... | 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 Product Name: setrusumab Product Code: BPS804 INN or Proposed INN: setrusumab Other descriptive name: A ... | 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 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - ( ... | 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. A Phase 2b, Multicentre, Multinational, Placebo-controlled, Double-blind, Dose-finding Study in Adul ... | 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] Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ... | Product Code: BPS804 INN or Proposed INN: Not established Other descriptive name: ANTI-SCLEROSTIN MONOCLONAL ANTIBODY Product Code: BPS804 INN or Proposed INN: Not established Other descriptive name: ANTI-SCLEROSTIN MONO ... | 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). A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, incorporating an open labe ... | 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] Osteogenesis imperfecta MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteogenes ... | 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 Product Name: setrusumab Product Code: BPS804 INN or Proposed INN: setrusumab Other descriptive name: A ... | 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 A randomized, open label intra-patient dose escalation study with an untreated reference group to ev ... | 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] Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic ... | Product Name: NA Product Code: BPS804 INN or Proposed INN: NA Other descriptive name: Anti-sclerostin monoclonal antibody Product Name: NA Product Code: BPS804 INN or Proposed INN: NA Other descriptive name: Anti-sclerostin m ... | 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 A randomized, open label intra-patient dose escalation study with an untreated reference group to ev ... | 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] Patients with previously established diagnosis of osteogenesis imperfecta (OI). OI is a rare genetic ... | Product Name: NA Product Code: BPS804 INN or Proposed INN: NA Other descriptive name: Anti-sclerostin monoclonal antibody Product Name: NA Product Code: BPS804 INN or Proposed INN: NA Other descriptive name: Anti-sclerostin m ... | 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 A Randomized, Open Label Intra-patient Dose Escalation Study With an Untreated Reference Group to Ev ... | 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. A Randomized, Double-Blind, Placebo-controlled, Phase 2/3 Study to Assess the Efficacy and Safety of ... | 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] Osteogenesis imperfecta (OI) MedDRA version: 20.0;Level: PT;Classification code 10031243;Term: Osteo ... | Product Name: Setrusumab Product Code: BPS804, UX143 INN or Proposed INN: SETRUSUMAB Other descriptive name: UX143, BPS804 Product Name: Setrusumab Product Code: BPS804, UX143 INN or Proposed INN: SETRUSUMAB Other descriptive ... | 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 |