Burosumab ( DrugBank: Burosumab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
238ビタミンD抵抗性くる病/骨軟化症8

238. ビタミンD抵抗性くる病/骨軟化症


臨床試験数 : 28 薬物数 : 20 - (DrugBank : 9) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 16
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04159675
(ClinicalTrials.gov)
September 4, 20207/11/2019Burosumab and 1-25 (OH) Vitamin D on Human OsteoblastsEffect of Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts From Patients Requiring Craniosynostosis Surgery for Idiopathic Reason or Due to Hypophosphatemic Rickets (HR)CraniosynostosesBiological: osteoblast biology studyHospices Civils de LyonNULLRecruiting4 Months18 YearsAll20France
2NCT04320316
(ClinicalTrials.gov)
July 31, 202011/3/2020A Trial to Assess the Safety and Efficacy of KRN23 in Epidermal Nevus Syndrome (ENS)An Open Label Trial to Assess the Safety and Efficacy of KRN23, an Investigational Antibody to FGF23, in a Single Pediatric Patient With Epidermal Nevus Syndrome (ENS) and Associated Hypophosphatemic RicketsEpidermal Nevus SyndromeDrug: Crysvita (burosumab-twza) TreatmentUniversity of Alabama at BirminghamUltragenyx Pharmaceutical IncCompleted6 MonthsN/AMale1Phase 4United States
3NCT03775187
(ClinicalTrials.gov)
April 5, 201911/12/2018Expanded Access to BurosumabX-linked Hypophosphatemia;Tumor-Induced OsteomalaciaBiological: BurosumabUltragenyx Pharmaceutical IncKyowa Kirin Co., Ltd.AvailableN/AN/AAllNULL
4NCT03581591
(ClinicalTrials.gov)
January 31, 201827/10/2017Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic RicketsAn Open Label Trial to Assess the Safety and Efficacy of Burosumab (KRN23), an Investigational Antibody to FGF23, in a Single Pediatric Patient With Epidermal Nevus Syndrome(ENS) and Associated Hypophosphatemic RicketsHypophosphatemia;Hypophosphatemic Rickets;Pain, ChronicBiological: BurosumabRedwood Dermatology SciencesUltragenyx Pharmaceutical IncCompletedN/A18 YearsFemale1Phase 3United States
5JPRN-JapicCTI-205284
09/1/201811/05/2020A Study of KRN23 in Adult and Pediatric Patients with X-linked Hypophosphatemic Rickets/OsteomalaciaPhase 3 Long-term Extension Study of KRN23 in Patients with X-linked Hypophosphatemic Rickets/Osteomalacia Adult or pediatric XLHIntervention name : burosumab
INN of the intervention : KRN23
Dosage And administration of the intervention : repeated SC administration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., Ltd.NULLcompleteBOTH27Phase 3Japan, Asia except Japan
6JPRN-JapicCTI-173614
31/7/201715/06/2017A Study of KRN23 in Pediatric Patients with X-linked Hypophosphatemic Rickets/OsteomalaciaA Phase 3 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Pediatric Patients with X-linked Hypophosphatemic Rickets/Osteomalacia X-linked Hypophosphatemic Rickets/OsteomalaciaIntervention name : KRN23
INN of the intervention : burosumab
Dosage And administration of the intervention : repeated SC administration
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., Ltd.NULLcomplete112BOTH10Phase 3Japan
7JPRN-JapicCTI-163191
23/4/201508/03/2016A Phase 2 Open-Label Trial of KRN23A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23 in Patients with Tumor-Induced Osteomalacia or Epidermal Nevus Syndrome Tumor-Induced Osteomalacia or Epidermal Nevus SyndromeIntervention name : KRN23
INN of the intervention : burosumab
Dosage And administration of the intervention : repeated SC administration, intraindividual dose adjustment
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Kyowa Kirin Co., Ltd.NULLcomplete18BOTH6Phase 2Japan, Asia except Japan
8NCT02304367
(ClinicalTrials.gov)
March 24, 201524/11/2014Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)A Phase 2 Open-Label Trial to Assess the Efficacy and Safety of KRN23, an Antibody to FGF23, in Subjects With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)-Associated OsteomalaciaTumor Induced Osteomalacia (TIO);Epidermal Nevus Syndrome (ENS)Biological: BurosumabUltragenyx Pharmaceutical IncNULLActive, not recruiting18 YearsN/AAll17Phase 2United States