CompletedPhase 2

Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia

United States24 participantsStarted 2017-07-12

Plain-language summary

This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with classic congenital adrenal hyperplasia (CAH).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female patients age 18 or older. * 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 unstable medical condition, illness, or chronic disease * 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.

What they're measuring

Safety of SPR001 in Patients With CAH

Timeframe: 6 weeks

Change in 17-hydroxyprogesterone

Timeframe: Cohort A: Baseline/2a (Day -1-0), First dose/2b (Day 0-1), Visit 3 (Day 13-14), Visit 4 (Day 27-28), Visit 5 (Day 41-42). Cohort B and Cohort C: Visit 2 (Day 0-1), Visit 3 (Day 8), Visit 4 (Day 14-15), Visit 5 (Last dose +30d)

Trial details

NCT IDNCT03257462

SponsorSpruce Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-03-02

Results submitted2025-02-26

View on ClinicalTrials.gov More Congenital Adrenal Hyperplasia trials