Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia
NCT ID: NCT03257462
Last Updated: 2025-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2017-07-12
2019-03-29
Brief Summary
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Detailed Description
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It is initially planned that up to approximately 18 patients in 2 dose cohorts will be enrolled. Additional patients or dose groups may be considered based upon specific safety, PK/PD, and/or efficacy findings, or if an active dose has not yet been reached.
SPR001 will be administered as an oral daily dose. Patients will undergo titration of SPR001 through three escalating dosage strengths at 2-week intervals. Patients will have overnight PK/PD assessments performed at baseline, which include an pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose. At the end of each 2-week dosing period, patients will return for single overnight visits for steady-state PK/PD assessments.
A follow-up outpatient visit will occur 30 days after their last dose.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort A
The first cohort of 9 patients will be administered SPR001 at dose strength of Dose A daily for 2 weeks, and escalating through Dose B per day for 2 weeks and Dose C per day for 2 weeks.
SPR001
SPR001 Capsules
Cohort B
Cohort B will begin enrollment after Cohort A has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort B will be determined by an interim review of safety and PK/PD data from from Cohort A.
SPR001
SPR001 Capsules
Cohort C
Cohort C will begin enrollment after Cohort B has been fully enrolled. Starting dose selection and the stepwise dosing paradigm for Cohort C will be determined by an interim review of safety and PK/PD data from from Cohort A and B.
SPR001
SPR001 Capsules
Interventions
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SPR001
SPR001 Capsules
Eligibility Criteria
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Inclusion Criteria
* Documented diagnosis of classic CAH due to 21-hydroxylase deficiency
* Elevated 17-OHP at screening
* On a stable glucocorticoid replacement regimen for a minimum of 30 days
Exclusion Criteria
* Clinically significant psychiatric disorder.
* Clinically significant abnormal laboratory finding or assessment
* History of bilateral adrenalectomy or hypopituitarism
* Pregnant or nursing females
* Use of any other investigational drug within 30 days
* Unable to understand and comply with the study procedures, understand the risks, and/or unwilling to provide written informed consent.
18 Years
ALL
No
Sponsors
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Spruce Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Spruce Chief Medical Officer, MD
Role: STUDY_DIRECTOR
Spruce Biosciences
Richard Auchus, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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Spruce Biosciences Clinical Site
Orange, California, United States
Spruce Biosciences Clinical Site
San Diego, California, United States
Spruce Biosciences Clinical Site
Melbourne, Florida, United States
Spruce Biosciences Clinical Site
Atlanta, Georgia, United States
Spruce Biosciences Clinical Site
Indianapolis, Indiana, United States
Spruce Biosciences Clinical Site
Ann Arbor, Michigan, United States
Spruce Biosciences Clinical Site
Minneapolis, Minnesota, United States
Spruce Biosciences Clinical Site
Las Vegas, Nevada, United States
Spruce Biosciences Clinical Site
Philadelphia, Pennsylvania, United States
Countries
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References
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Sarafoglou K, Barnes CN, Huang M, Imel EA, Madu IJ, Merke DP, Moriarty D, Nakhle S, Newfield RS, Vogiatzi MG, Auchus RJ. Tildacerfont in Adults With Classic Congenital Adrenal Hyperplasia: Results from Two Phase 2 Studies. J Clin Endocrinol Metab. 2021 Oct 21;106(11):e4666-e4679. doi: 10.1210/clinem/dgab438.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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On-line clinical study-related information for patients, including pre-screening questionnaire.
Other Identifiers
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SPR001-201
Identifier Type: -
Identifier Source: org_study_id
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