Trial · NCT03687242

Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia

NCT03687242, Phase 2, Completed, Spruce Biosciences; results first posted 2025-04-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia. Trials, record NCT03687242. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03687242

On this page

Trial

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

Title: Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia
NCT number: NCT03687242
Status: Completed
Phases: Phase 2
Enrollment: 11 participants, actual
Lead sponsor: Spruce Biosciences
Conditions: Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia, CAH - 21-Hydroxylase Deficiency
Interventions: SPR001
First posted: 2018-09-27
Last updated: 2025-04-01
Results first posted: 2025-04-01

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	The Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) in Subjects With CAH	Over 12 weeks	Incidence of treatment-emergent adverse events including any serious adverse events, dose-limiting toxicities, and adverse events leading to discontinuation of study drug.
Secondary	Change From Baseline in 17-hydroxyprogesterone (17-OHP)	Week 12	Change from Baseline to Week 12 in 17-OHP following dosing of SPR001 in subjects with CAH. 17-OHP is measured in patient serum sample. Results are expressed as mean percent change from baseline. Reductions in 17-OHP are indicators of better disease control.
Secondary	Change From Baseline in Androstenedione (A4)	Week 12	Change from Baseline to Week 12 in androstenedione (A4) following dosing of SPR001 in subjects with CAH. A4 is measured in patient serum. Results are expressed as mean percent change from baseline. Reductions in A4 are indicators of better disease control.
Secondary	Change From Baseline in Adrenocorticotropic Hormone (ACTH)	Week 12	Change from Baseline to Week 12 in adrenocorticotropic hormone (ACTH) following dosing of SPR001 in subjects with CAH. ACTH is measured in patient serum. Results are expressed as mean percent change from baseline. Reductions in ACTH are indicators of better disease control.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	The Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) in Subjects With CAH	Over 12 weeks	Participants who received at least one dose of study drug.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in 17-hydroxyprogesterone (17-OHP)	Week 12	One subject was withdrawn prematurely on Day 24 due to adverse events and is not included in the efficacy analyses.	percentage of change from baseline	MEAN
SECONDARY	Change From Baseline in Androstenedione (A4)	Week 12	One subject was withdrawn prematurely on Day 24 due to adverse events and is not included in the efficacy analyses.	percentage of mean change from baseline	MEAN
SECONDARY	Change From Baseline in Adrenocorticotropic Hormone (ACTH)	Week 12	One subject was withdrawn prematurely on Day 24 due to adverse events and is not included in the efficacy analyses.	percentage of mean change from baseline	MEAN

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Category	Value	Spread	Units
The Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) in Subjects With CAH	SPR001	Subjects experiencing adverse events	9		Participants
The Incidence of Treatment-emergent Adverse Events (Safety and Tolerability) in Subjects With CAH	SPR001	Subjects who did not experience adverse events	2		Participants
Change From Baseline in 17-hydroxyprogesterone (17-OHP)	SPR001		-43.4	Standard Deviation 47.83	percentage of change from baseline
Change From Baseline in Androstenedione (A4)	SPR001		34.0	Standard Deviation 238.20	percentage of mean change from baseline
Change From Baseline in Adrenocorticotropic Hormone (ACTH)	SPR001		-45.64	Standard Deviation 6.244	percentage of mean change from baseline

Source ClinicalTrials.gov

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	SPR001	11
Overall Study	COMPLETED	SPR001	10
Overall Study	NOT COMPLETED	SPR001	1

Source ClinicalTrials.gov

Adverse events18

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	Events
other	Hypothyroidism	Endocrine disorders	SPR001	1	11	1
other	Lacrimation increased	Eye disorders	SPR001	1	11	1
other	Abdominal pain upper	Gastrointestinal disorders	SPR001	1	11	1
other	Diarrhoea	Gastrointestinal disorders	SPR001	1	11	1
other	Nausea	Gastrointestinal disorders	SPR001	1	11	1
other	Vomiting	Gastrointestinal disorders	SPR001	1	11	1
other	Upper respiratory tract infection	Infections and infestations	SPR001	2	11	2
other	Nasopharyngitis	Infections and infestations	SPR001	1	11	1
other	Contusion	Injury, poisoning and procedural complications	SPR001	1	11	1
other	Glycosylated haemoglobin increased	Investigations	SPR001	1	11	1

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	SPR001	0	11
Total, other adverse events	SPR001	9	11
Total, serious adverse events	SPR001	0	11

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34146101	RESULT

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 comparisons0

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

None in this release.

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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license 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/NCT03687242

GET https://conductscience.org/api/trials/v1/NCT03687242/registered

API reference For AI assistants