SETRUSUMAB ( DrugBank: Setrusumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
274骨形成不全症6

274. 骨形成不全症


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.TrialIDDate_
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PhaseCountries
1NCT05312697
(ClinicalTrials.gov)
April 28, 202228/3/2022Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis ImperfectaA Phase 2b, Multicenter, Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis ImperfectaOsteogenesis ImperfectaBiological: SetrusumabUltragenyx Pharmaceutical IncMereo BioPharmaTerminated19 Years80 YearsAll2Phase 2United States
2NCT05125809
(ClinicalTrials.gov)
February 21, 20228/11/2021Study to Assess Dose, Efficacy and Safety of Setrusumab in Participants With Osteogenesis ImperfectaAn Operationally Seamless, Randomized Phase 2/3 Study Consisting of a Phase 2 Single-Blind, Dose-Evaluation Phase and a Phase 3 Double-Blind, Placebo-Controlled Phase to Assess the Efficacy and Safety of Setrusumab in Subjects With Osteogenesis ImperfectaOsteogenesis ImperfectaBiological: Setrusumab;Other: PlaceboUltragenyx Pharmaceutical IncMereo BioPharmaRecruiting5 Years25 YearsAll219Phase 2/Phase 3United States;Argentina;Australia;Canada;France;Germany;Italy;Netherlands;Poland;Portugal;Turkey;United Kingdom;Denmark
3NCT03118570
(ClinicalTrials.gov)
September 11, 20173/4/2017A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804Protocol 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 IVDrug: BPS804Ultragenyx Pharmaceutical IncNULLCompleted18 Years75 YearsAll112Phase 2United States;Canada;Denmark;France;United Kingdom
4EUCTR2016-005096-27-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
5EUCTR2016-005096-27-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
6EUCTR2021-006597-23-FR
(EUCTR)
04/05/2022A 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.NULLNAFemale: yes
Male: yes
231Phase 2;Phase 3United States;France;Canada;Argentina;Denmark;Australia;Germany;United Kingdom;Italy