Trial · NCT04490915

Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia

NCT04490915, Phase 3, Active not recruiting, Neurocrine Biosciences; results first posted 2025-02-05

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia. Trials, record NCT04490915. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04490915

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia
NCT number: NCT04490915
Status: Active not recruiting
Phases: Phase 3
Enrollment: 182 participants, actual
Lead sponsor: Neurocrine Biosciences
Conditions: Congenital Adrenal Hyperplasia
Interventions: Crinecerfont, Placebo
First posted: 2020-07-29
Last updated: 2026-05-11
Other registries' IDs: eudract:2019-004873-17
Results first posted: 2025-02-05

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24	Baseline, Week 24	Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Secondary	Change From Baseline in Serum Androstenedione at Week 4	Baseline, Week 4
Secondary	Number of Participants Who Achieved a Reduction to Physiologic Glucocorticoid Dose While Maintaining Androstenedione Control at Week 24	Week 24
Secondary	Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 24	Baseline, Week 24
Secondary	Percent Change From Baseline in Body Weight at Week 24	Baseline, Week 24
Secondary	Change From Baseline in Percent Total Fat Mass at Week 24	Baseline, Week 24
Secondary	Change From Baseline in Serum 17-hydroxyprogesterone (17-OHP) at Week 4	Baseline, Week 4
Secondary	Change From Baseline in Blood Pressure at Week 24	Baseline, Week 24
Secondary	Change From Baseline in Glucose Tolerance at Week 24	Baseline, Week 24
Secondary	Change From Baseline in Waist Circumference at Week 24	Baseline, Week 24

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24	Baseline, Week 24	Full Analysis Set included all randomized participants.	percent change	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Serum Androstenedione at Week 4	Baseline, Week 4
SECONDARY	Number of Participants Who Achieved a Reduction to Physiologic Glucocorticoid Dose While Maintaining Androstenedione Control at Week 24	Week 24
SECONDARY	Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at Week 24	Baseline, Week 24
SECONDARY	Percent Change From Baseline in Body Weight at Week 24	Baseline, Week 24
SECONDARY	Change From Baseline in Percent Total Fat Mass at Week 24	Baseline, Week 24
SECONDARY	Change From Baseline in Serum 17-hydroxyprogesterone (17-OHP) at Week 4	Baseline, Week 4
SECONDARY	Change From Baseline in Blood Pressure at Week 24	Baseline, Week 24
SECONDARY	Change From Baseline in Glucose Tolerance at Week 24	Baseline, Week 24
SECONDARY	Change From Baseline in Waist Circumference at Week 24	Baseline, Week 24

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24	Placebo		-10.300	Standard Error 3.247	percent change
Percent Change From Baseline in Glucocorticoid Daily Dose at Week 24	Crinecerfont		-27.322	Standard Error 2.418	percent change

Source ClinicalTrials.gov

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
DB Treatment Period (24 Weeks)	STARTED	Placebo	60
DB Treatment Period (24 Weeks)	STARTED	Crinecerfont	122
DB Treatment Period (24 Weeks)	Received at Least 1 Dose of Study Drug	Placebo	59
DB Treatment Period (24 Weeks)	Received at Least 1 Dose of Study Drug	Crinecerfont	122
DB Treatment Period (24 Weeks)	COMPLETED	Placebo	57
DB Treatment Period (24 Weeks)	COMPLETED	Crinecerfont	117
DB Treatment Period (24 Weeks)	NOT COMPLETED	Placebo	3
DB Treatment Period (24 Weeks)	NOT COMPLETED	Crinecerfont	5
OL Treatment Period (6 Months)	STARTED	Placebo	57
OL Treatment Period (6 Months)	STARTED	Crinecerfont	117

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fatigue	General disorders	DB Period: Placebo	9	59
other	Fatigue	General disorders	DB Period: Crinecerfont	30	122
other	Headache	Nervous system disorders	DB Period: Placebo	9	59
other	Headache	Nervous system disorders	DB Period: Crinecerfont	19	122
other	Coronavirus infection	Infections and infestations	DB Period: Placebo	5	59
other	Coronavirus infection	Infections and infestations	DB Period: Crinecerfont	17	122
other	Upper respiratory tract infection	Infections and infestations	DB Period: Placebo	7	59
other	Upper respiratory tract infection	Infections and infestations	DB Period: Crinecerfont	11	122
other	Diarrhoea	Gastrointestinal disorders	DB Period: Placebo	5	59
other	Diarrhoea	Gastrointestinal disorders	DB Period: Crinecerfont	10	122

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DB Period: Placebo	0	60
Total, all-cause mortality	DB Period: Crinecerfont	0	122
Total, other adverse events	DB Period: Placebo	39	59
Total, other adverse events	DB Period: Crinecerfont	76	122
Total, serious adverse events	DB Period: Placebo	0	59
Total, serious adverse events	DB Period: Crinecerfont	4	122

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38828955	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
DB Period: Crinecerfont vs DB Period: Placebo: deaths from any cause	Trial comparisons
DB Period: Crinecerfont vs DB Period: Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT04490915

GET https://conductscience.org/api/trials/v1/NCT04490915/events?page=2

API reference For AI assistants