NBI-74788 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
81先天性副腎皮質酵素欠損症20

81. 先天性副腎皮質酵素欠損症


臨床試験数 : 87 薬物数 : 87 - (DrugBank : 23) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 68
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-004381-19-DE
(EUCTR)
16/12/202109/04/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
81Phase 3France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy;Sweden
2EUCTR2020-004381-19-IT
(EUCTR)
13/10/202130/08/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment - n/a Congenital adrenal hyperplasia (CAH) is a group of rare inherited endocrine disorders characterized by a deficiency of one of the enzymes needed to make specific hormones.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: [NBI-74788]
Other descriptive name: Crinecerfont is a novel non-peptide selective corticotropin releasing factor 1 (CRF1 ) receptor antagonist.
Product Name: Crinecerfont
Product Code: [NBI-74788]
Other descriptive name: Crinecerfont is a novel non-peptide selective corticotropin releasing factor 1 (CRF1 ) receptor antagonist.
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden
3EUCTR2020-004381-19-ES
(EUCTR)
13/08/202113/08/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3France;United States;Greece;Canada;Poland;Belgium;Spain;Germany;Italy;Sweden
4EUCTR2019-004873-17-NL
(EUCTR)
20/07/202112/11/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment (CAHTALYST) Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Germany;Sweden
5NCT04806451
(ClinicalTrials.gov)
June 24, 202116/3/2021Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label TreatmentCongenital Adrenal HyperplasiaDrug: Crinecerfont;Drug: PlaceboNeurocrine BiosciencesNULLActive, not recruiting2 Years17 YearsAll103Phase 3United States;Belgium;Canada;France;Germany;Greece;Italy;Poland;Spain;United Kingdom
6EUCTR2020-004381-19-FR
(EUCTR)
23/06/202121/04/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3United States;France;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden
7EUCTR2020-004381-19-GR
(EUCTR)
07/06/202106/04/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
81Phase 3France;United States;Canada;Greece;Spain;Poland;Belgium;Germany;Italy;Sweden
8EUCTR2019-004873-17-AT
(EUCTR)
17/02/202107/10/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden
9EUCTR2019-004873-17-DE
(EUCTR)
15/01/202119/05/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden;Czech Republic;Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France
10EUCTR2019-004873-17-BG
(EUCTR)
17/12/202003/07/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden
11EUCTR2019-004873-17-IT
(EUCTR)
16/12/202024/05/2021A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment - n/a Congenital adrenal hyperplasia (CAH) is a group of rare inherited endocrine disorders characterized by a deficiency of one of the enzymes needed to make specific hormones.
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: [NBI-74788]
Other descriptive name: Crinecerfont is a novel non-peptide selective corticotropin releasing factor 1 (CRF1 ) receptor antagonist.
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden;United States;Portugal;Czechia
12EUCTR2019-004873-17-CZ
(EUCTR)
07/12/202022/05/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Serbia;Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden
13EUCTR2019-004873-17-PL
(EUCTR)
01/12/202003/07/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Germany;Sweden
14EUCTR2019-004873-17-GB
(EUCTR)
15/10/202030/04/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Sweden
15EUCTR2019-004873-17-PT
(EUCTR)
12/10/202030/06/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;United States;Czechia;Greece;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Sweden
16EUCTR2019-004873-17-GR
(EUCTR)
29/07/202030/07/2020A study of safety and efficacy of NBI-74788 in Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;Serbia;United States;Czechia;Greece;Spain;Ukraine;Turkey;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Germany;Sweden
17NCT04490915
(ClinicalTrials.gov)
July 23, 202024/7/2020Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Adult Subjects With Classic Congenital Adrenal Hyperplasia, Followed by Open-Label TreatmentCongenital Adrenal HyperplasiaDrug: Crinecerfont;Drug: PlaceboNeurocrine BiosciencesNULLActive, not recruiting18 YearsN/AAll182Phase 3United States;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Portugal;Serbia;Spain;Sweden;United Kingdom
18NCT03525886
(ClinicalTrials.gov)
April 10, 20182/5/2018Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adults With Congenital Adrenal HyperplasiaA Phase 2, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of NBI-74788 in Adult Subjects With Congenital Adrenal HyperplasiaCAH - Congenital Adrenal HyperplasiaDrug: NBI-74788Neurocrine BiosciencesNULLCompleted18 Years50 YearsAll18Phase 2United States
19EUCTR2020-004381-19-BE
(EUCTR)
25/06/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLNAFemale: yes
Male: yes
81Phase 3France;United States;Greece;Canada;Spain;Poland;Belgium;Germany;Italy;Sweden
20EUCTR2020-004381-19-PL
(EUCTR)
10/05/2021Study to Evaluate the Safety and Efficacy of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal HyperplasiaA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Crinecerfont (NBI-74788) in Pediatric Subjects with Classic Congenital Adrenal Hyperplasia, Followed by Open-Label Treatment Classic Congenital Adrenal Hyperplasia (CAH)
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Product Name: Crinecerfont
Product Code: NBI-74788
INN or Proposed INN: Crinecerfont
Neurocrine Biosciences, Inc.NULLNAFemale: yes
Male: yes
81Phase 3United States;France;Greece;Canada;Spain;Belgium;Poland;Germany;Italy;Sweden