GLPG2737 ( DrugBank: - )


2 diseases
告示番号疾患名(ページ内リンク)臨床試験数
67多発性嚢胞腎7
299嚢胞性線維症5

67. 多発性嚢胞腎


臨床試験数 : 221 薬物数 : 212 - (DrugBank : 55) / 標的遺伝子数 : 40 - 標的パスウェイ数 : 151
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04578548
(ClinicalTrials.gov)
November 10, 20201/10/2020A Study to Evaluate the Effects of GLPG2737 in Participants With Autosomal Dominant Polycystic Kidney Disease (ADPKD)An Exploratory, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of Orally Administered GLPG2737 for 52 Weeks, Followed by an Open-label Extension Period of 52 Weeks in Subjects With Autosomal Dominant Polycystic Kidney DiseaseAutosomal Dominant Polycystic Kidney DiseaseDrug: Placebo;Drug: GLPG2737Galapagos NVNULLActive, not recruiting18 Years50 YearsAll66Phase 2Belgium;Czechia;Germany;Italy;Netherlands;Poland;Spain
2EUCTR2019-003521-21-CZ
(EUCTR)
14/10/202028/07/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenterstudy to evaluate the efficacy, safety, tolerability and pharmacokinetics oforally administered GLPG2737 for 52 weeks, followed by an open-labelextension period of 52 weeks in subjects with autosomal dominantpolycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
3EUCTR2019-003521-21-DE
(EUCTR)
14/09/202010/03/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Netherlands;Germany;Italy
4EUCTR2019-003521-21-IT
(EUCTR)
22/07/202011/01/2021A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease - A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney di Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: [G1117337]
Other descriptive name: GLPG2737
GALAPAGOS NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Greece;Belgium;Ireland;Bulgaria;Netherlands;Germany;United Kingdom;Italy
5EUCTR2019-003521-21-NL
(EUCTR)
18/03/202007/11/2019A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
6EUCTR2019-003521-21-BE
(EUCTR)
20/01/202024/10/2019A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, followed by an open-label extension period of 52 weeks in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Spain;Belgium;Germany;Netherlands;Italy
7EUCTR2019-003521-21-ES
(EUCTR)
28/05/2020A study to evaluate the effects of GLPG2737 in subjects with autosomal dominant polycystic kidney diseaseAn exploratory, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered GLPG2737 for 52 weeks, in subjects with autosomal dominant polycystic kidney disease Autosomal dominant polycystic kidney disease
MedDRA version: 20.0;Level: LLT;Classification code 10036046;Term: Polycystic kidney, autosomal dominant;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Czech Republic;Belgium;Spain;Germany;Netherlands;Italy

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000098-61-GB
(EUCTR)
22/06/201801/06/2018A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in adult patients with cystic fibrosisA Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG3067
Product Code: G914167
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3067
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
144 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;United States;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;New Zealand;United Kingdom
2NCT03540524
(ClinicalTrials.gov)
May 31, 201827/4/2018A Study Looking at the Safety, Tolerability and Efficacy of the Combination of the Study Drugs GLPG2451 and GLPG2222 With or Without GLPG2737 in Patients With Cystic Fibrosis.Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of the Combination of GLPG2451 and GLPG2222, With or Without GLPG2737, in Adult Subjects With Cystic FibrosisCystic FibrosisDrug: GLPG2451 dose regimen A;Drug: GLPG2451 dose regimen B;Drug: GLPG2222;Drug: GLPG2737Galapagos NVNULLCompleted18 YearsN/AAll10Phase 1Belgium;Bulgaria;Germany;Greece;Netherlands;Serbia;Sweden;United Kingdom
3NCT03474042
(ClinicalTrials.gov)
November 29, 201715/3/2018GLPG2737 on Top of Orkambi in Subjects With Cystic FibrosisA Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del MutationCystic FibrosisDrug: GLPG2737;Drug: PlaceboGalapagos NVNULLCompleted18 YearsN/AAll22Phase 2Germany
4EUCTR2017-002181-42-DE
(EUCTR)
27/10/201728/07/2017GLPG2737 on top of Orkambi in subjects with cystic fibrosisA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
5NCT03450720
(ClinicalTrials.gov)
June 28, 201723/2/2018Pharmacokinetics of GLPG2737 in Male Subjects With Cystic FibrosisEvaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic FibrosisCystic FibrosisDrug: GLPG2737 single doseGalapagos NVNULLCompleted18 YearsN/AMale6Phase 1Belgium