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Spr001    (DrugBank: -)

1 disease
IDDisease name (Link within this page)Number of trials
81Congenital adrenal hyperplasia12

81. Congenital adrenal hyperplasia    [ 65 clinical trials,   77 drugs,   (DrugBank: 20 drugs),   11 drug target genes,   65 drug target pathways]
Searched query = "Congenital adrenal hyperplasia", "Congenital adrenal enzyme deficiency", "Congenial adrenal cortex enzyme deficiency", "Congenital Lipoid Adrenal Hyperplasia", "3β-Hydroxysteroid Dehydrogenase Deficiency", "21-Hydroxylase deficiency", "11β-Hydroxylase deficiency", "17α-Hydroxylase deficiency", "P450 oxidoreductase deficiency", "Aldosterone synthase deficiency"
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.
12 / 65 trials found
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
1EUCTR2019-004764-22-GB
(EUCTR)		23/12/202009/07/2020This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that will evaluate the efficacy and safety of up to 52 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baselineA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia Classic Congenital Adrenal Hyperplasia
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: Tildacerfont
Product Code: SPR001
INN or Proposed INN: TILDACERFONT		Spruce Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		72Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
2EUCTR2019-004765-40-DE
(EUCTR)		20/11/202018/09/2020This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH Classic Congenital Adrenal Hyperplasia
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: Tildacerfont
Product Code: SPR001
INN or Proposed INN: TILDACERFONT		Spruce Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		60Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
3EUCTR2019-004764-22-DK
(EUCTR)		17/11/202009/07/2020This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that will evaluate the efficacy and safety of up to 52 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baselineA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia Classic Congenital Adrenal Hyperplasia
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: Tildacerfont
Product Code: SPR001
INN or Proposed INN: TILDACERFONT		Spruce Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		72Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
4EUCTR2019-004765-40-DK
(EUCTR)		17/11/202016/09/2020This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH Classic Congenital Adrenal Hyperplasia
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: Tildacerfont
Product Code: SPR001
INN or Proposed INN: TILDACERFONT		Spruce Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		60Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
5EUCTR2019-004765-40-SE
(EUCTR)		03/11/202018/09/2020This is a randomized, double-blinded, Placebo controlled trial that will evaluate the potential of tildacerfont to reduce GC use in adult subjects with classic CAH who are on supraphysiologic doses of GC therapy.A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of tildacerfont in Reducing Supraphysiologic GC doses in adult subjects with CAH Classic Congenital Adrenal Hyperplasia
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: Tildacerfont
Product Code: SPR001
INN or Proposed INN: TILDACERFONT		Spruce Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		60Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
6EUCTR2019-004764-22-NL
(EUCTR)		15/10/202001/07/2020This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that will evaluate the efficacy and safety of up to 52 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baselineA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia Classic Congenital Adrenal Hyperplasia
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: Tildacerfont
Product Code: SPR001
INN or Proposed INN: TILDACERFONT		Spruce Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		72Phase 2Poland;United States;Spain;Israel;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Germany;Norway;Sweden
7EUCTR2019-004764-22-DE
(EUCTR)		08/10/202008/07/2020This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that will evaluate the efficacy and safety of up to 52 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baselineA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia Classic Congenital Adrenal Hyperplasia
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: Tildacerfont
Product Code: SPR001
INN or Proposed INN: TILDACERFONT		Spruce Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		72Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
8NCT04544410
(ClinicalTrials.gov)		September 29, 202030/8/2020A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAHA Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Reducing Supraphysiologic Glucocorticoid Use in Adult Subjects With Classic Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: Tildacerfont/PlaceboSpruce BiosciencesNULLRecruiting18 Years55 YearsAll60Phase 2United States
9EUCTR2019-004764-22-SE
(EUCTR)		26/08/202008/07/2020This is a randomized, double-blinded, Placebo controlled trial with a 3-part treatment period that will evaluate the efficacy and safety of up to 52 weeks of treatment with tildacerfont in subjects with classic Congenital adrenal hyperplasia (CAH) who have elevated blood hormones at baselineA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects with Classic Congenital Adrenal Hyperplasia - Efficacy and Safety of Tildacerfont in Adult Subjects with Classic Congenital Adrenal Hyperplasia Classic Congenital Adrenal Hyperplasia
MedDRA version: 20.0;Level: LLT;Classification code 10010323;Term: Congenital adrenal hyperplasia;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]		Product Name: Tildacerfont
Product Code: SPR001
INN or Proposed INN: TILDACERFONT		Spruce Biosciences, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes		72Phase 2United States;France;Spain;Poland;Denmark;Netherlands;Germany;United Kingdom;Sweden
10NCT04457336
(ClinicalTrials.gov)		August 26, 202025/6/2020A Ph2b to Evaluate Clinical Efficacy and Safety of Tildacerfont in Adult CAHA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of SPR001 (Tildacerfont) in Adult Subjects With Classic Congenital Adrenal HyperplasiaCongenital Adrenal HyperplasiaDrug: Tildacerfont/PlaceboSpruce BiosciencesNULLRecruiting18 Years55 YearsAll72Phase 2United States
No.TrialIDDate_
enrollment		Date_
registration		Public_titleScientific_titleConditionInterventionPrimary_
sponsor		Secondary_
sponsor		Recruitment_
Status		Inclusion_
agemin		Inclusion_
agemax		Inclusion_
gender		Target_
size		PhaseCountries
11NCT03687242
(ClinicalTrials.gov)		September 6, 201811/9/2018Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal HyperplasiaA 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal HyperplasiaCongenital Adrenal Hyperplasia;CAH - Congenital Adrenal Hyperplasia;CAH - 21-Hydroxylase DeficiencyDrug: SPR001Spruce BiosciencesNULLCompleted18 YearsN/AAll11Phase 2United States
12NCT03257462
(ClinicalTrials.gov)		July 26, 201715/8/2017Study of SPR001 in Adults With Classic Congenital Adrenal HyperplasiaA Phase 2, Multiple-Dose, Dose-Escalation Study to Evaluate the Safety and Efficacy of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia (CAH)Congenital Adrenal Hyperplasia;CAH - Congenital Adrenal HyperplasiaDrug: SPR001Spruce BiosciencesNULLCompleted18 YearsN/AAll26Phase 2United States

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