Trial · NCT04806451

Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)

NCT04806451, 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 in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study). Trials, record NCT04806451. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04806451

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Trial

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

Title: Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Participants With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study)
NCT number: NCT04806451
Status: Active not recruiting
Phases: Phase 3
Enrollment: 103 participants, actual
Lead sponsor: Neurocrine Biosciences
Conditions: Congenital Adrenal Hyperplasia
Interventions: Crinecerfont, Placebo
First posted: 2021-03-19
Last updated: 2025-02-05
Other registries' IDs: eudract:2020-004381-19
Results first posted: 2025-02-05

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Serum Androstenedione at Week 4	Baseline, Week 4	Blood serum samples were collected for the analysis of serum androstenedione concentrations. Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Secondary	Change From Baseline in Serum 17-hydroxyprogesterone (17-OHP) at Week 4	Baseline, Week 4
Secondary	Percent Change From Baseline in Glucocorticoid Daily Dose at Week 28	Baseline, Week 28
Secondary	Number of Participants Who Achieved a Reduction to Physiologic Glucocorticoid Dose While Maintaining Androstenedione Control at Week 28	Week 28
Secondary	Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) at Week 28	Baseline, Week 28
Secondary	Change From Baseline in Mean 24-hour Salivary 17-OHP at Week 28	Baseline, Week 28
Secondary	Change From Baseline in the Ratio of Bone Age to Chronological Age (BA:CA) at Week 28	Baseline, Week 28

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Serum Androstenedione at Week 4	Baseline, Week 4	Full Analysis Set included all randomized participants.	ng/dL	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Serum 17-hydroxyprogesterone (17-OHP) at Week 4	Baseline, Week 4
SECONDARY	Percent Change From Baseline in Glucocorticoid Daily Dose at Week 28	Baseline, Week 28
SECONDARY	Number of Participants Who Achieved a Reduction to Physiologic Glucocorticoid Dose While Maintaining Androstenedione Control at Week 28	Week 28
SECONDARY	Change From Baseline in Body Mass Index (BMI) Standard Deviation Score (SDS) at Week 28	Baseline, Week 28
SECONDARY	Change From Baseline in Mean 24-hour Salivary 17-OHP at Week 28	Baseline, Week 28
SECONDARY	Change From Baseline in the Ratio of Bone Age to Chronological Age (BA:CA) at Week 28	Baseline, Week 28

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Serum Androstenedione at Week 4	Placebo		70.986	Standard Error 56.198	ng/dL
Change From Baseline in Serum Androstenedione at Week 4	Crinecerfont		-196.789	Standard Error 39.369	ng/dL

Source ClinicalTrials.gov

Participant flow16

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

Period	Milestone	Group	Participants
DB Treatment Period (28 Weeks)	STARTED	Placebo	34
DB Treatment Period (28 Weeks)	STARTED	Crinecerfont	69
DB Treatment Period (28 Weeks)	Received at Least 1 Dose of Study Drug	Placebo	33
DB Treatment Period (28 Weeks)	Received at Least 1 Dose of Study Drug	Crinecerfont	69
DB Treatment Period (28 Weeks)	COMPLETED	Placebo	31
DB Treatment Period (28 Weeks)	COMPLETED	Crinecerfont	66
DB Treatment Period (28 Weeks)	NOT COMPLETED	Placebo	3
DB Treatment Period (28 Weeks)	NOT COMPLETED	Crinecerfont	3
OL Treatment Period (24 Weeks)	STARTED	Placebo	31
OL Treatment Period (24 Weeks)	STARTED	Crinecerfont	66

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events58

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	Headache	Nervous system disorders	DB Period: Placebo	2	33
other	Headache	Nervous system disorders	DB Period: Crinecerfont	17	69
other	Pyrexia	General disorders	DB Period: Placebo	8	33
other	Pyrexia	General disorders	DB Period: Crinecerfont	15	69
other	Vomiting	Gastrointestinal disorders	DB Period: Placebo	8	33
other	Vomiting	Gastrointestinal disorders	DB Period: Crinecerfont	10	69
other	Upper respiratory tract infection	Infections and infestations	DB Period: Placebo	0	33
other	Upper respiratory tract infection	Infections and infestations	DB Period: Crinecerfont	8	69
other	Nasopharyngitis	Infections and infestations	DB Period: Placebo	6	33
other	Nasopharyngitis	Infections and infestations	DB Period: Crinecerfont	7	69

1 to 10 of 58Source ClinicalTrials.gov

See all 58 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	34
Total, all-cause mortality	DB Period: Crinecerfont	0	69
Total, other adverse events	DB Period: Placebo	22	33
Total, other adverse events	DB Period: Crinecerfont	51	69
Total, serious adverse events	DB Period: Placebo	4	33
Total, serious adverse events	DB Period: Crinecerfont	1	69

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38828945	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/NCT04806451

GET https://conductscience.org/api/trials/v1/NCT04806451/events?page=2

API reference For AI assistants