Home    Back

Bps804    (DrugBank: -)

2 diseases
IDDisease name (Link within this page)Number of trials
172Hypophosphatasia2
274Osteogenesis Imperfecta8

172. Hypophosphatasia    [ 32 clinical trials,   18 drugs,   (DrugBank: 4 drugs),   3 drug target genes,   6 drug target pathways]
Searched query = "Hypophosphatasia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 32 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT01406977
(ClinicalTrials.gov)		July 201129/7/2011Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP)An Open-label, Intra-patient Dose-escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP).HypophosphatasiaDrug: BPS804Novartis PharmaceuticalsNULLCompleted18 Years70 YearsBoth9Phase 2Germany
2EUCTR2010-024013-31-DE
(EUCTR)		30/06/201107/02/2011A clinical study to evaluate the safety and preliminary efficacy of BPS804 in adults with hypophosphatasiaAn open-label, intra-patient dose-escalation study to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of multiple infusions of BPS804 in adults with hypophosphatasia Hypophosphatasia (HPP) is a rare genetic metabolic disorder which results in impaired skeletal mineralization, and which is caused by the absence of or by deficient enzymatic activity of the tissue-nonspecific alkaline phosphatase (TNSALP)
MedDRA version: 14.1;Level: PT;Classification code 10049933;Term: Hypophosphatasia;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]		Product Name: BPS804
Product Code: BPS804
Other descriptive name: fully human IgG2 lambda monoclonal antibody		Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes		9Germany

274. Osteogenesis Imperfecta    [ 78 clinical trials,   87 drugs,   (DrugBank: 19 drugs),   14 drug target genes,   74 drug target pathways]
Searched query = "Osteogenesis Imperfecta"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
8 / 78 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1NCT03216486
(ClinicalTrials.gov)		October 31, 201712/7/2017An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis ImperfectaA Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis ImperfectaOsteogenesis ImperfectaDrug: BPS804Mereo BioPharmaICON Clinical ResearchWithdrawn18 YearsN/AAll0Phase 2United States
2NCT03118570
(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: BPS804Mereo BioPharmaICON Clinical ResearchActive, not recruiting18 Years75 YearsAll100Phase 2United States;Canada;Denmark;France;United Kingdom
3EUCTR2016-005096-27-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]		Mereo Biopharma 3 Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		100Phase 2France;United States;Canada;Denmark;United Kingdom
4EUCTR2016-005096-27-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]		Mereo Biopharma 3 Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes		140Phase 2United States;France;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
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2011-001465-41-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
7EUCTR2011-001465-41-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
8NCT01417091
(ClinicalTrials.gov)		June 20114/8/2011Safety, Pharmacokinetics and Pharmacodynamics of BPS804 in 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 ImperfectaOsteogenesis ImperfectaDrug: BPS804Novartis PharmaceuticalsNULLCompleted18 Years75 YearsBoth10Phase 2United States;Belgium;Canada;Germany

Back to top