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

  
5 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2016-005096-27-GB
(EUCTR)
25/08/201719/02/2018A 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.NULLAuthorised-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): noFrance;United States;Canada;Denmark;United Kingdom
2EUCTR2016-005096-27-FR
(EUCTR)
24/07/201707/02/2019A study of test product BPS804 compared to placebo in adults with brittle bone syndromeA 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.NULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;France;Canada;Denmark;United Kingdom
3EUCTR2016-005096-27-DK
(EUCTR)
23/06/201724/03/2017A 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.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2United States;France;Canada;Denmark;United Kingdom
4EUCTR2011-001465-41-DE
(EUCTR)
23/01/201209/08/2011Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfectaA 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 AGNULLNot RecruitingFemale: yes
Male: yes
15Canada;Germany
5EUCTR2011-001465-41-BE
(EUCTR)
20/07/201123/05/2011Safety and pharmacokinetics clinical of BPS804 in adult patients with osteogenesis imperfectaA 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 AGNULLNot RecruitingFemale: yes
Male: yes
15Phase 1;Phase 2Canada;Belgium;Germany