TerminatedPhase 2

A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH

Stopped: The SPR001-203 clinical trial did not achieve the primary efficacy endpoint of the absolute change in daily GC dose from baseline at week 24. It was decided to terminate the SPR001-205 in response to the SPR001-203 efficacy data.

United States67 participantsStarted 2021-12-10

Plain-language summary

An investigation of the safety and efficacy of tildacerfont in participants with CAH.

Who can participate

Age range2 Years

SexALL

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Inclusion Criteria: * Male and female subjects aged 2+ * Diagnosis of CAH due to 21-hydroxylase deficiency (OHD) and/or elevated 17- hydroxyprogesterone (OHP) requiring ongoing GC replacement since diagnosis * Stable dose of GC replacement for at least 1 month prior to screening Exclusion Criteria: * History of bilateral adrenalectomy or hypopituitarism * Clinically significant unstable medical conditions, illness, or chronic diseases * History of active bleeding disorders

What they're measuring

Number of Participants With Treatment-emergent Adverse Event (TEAE) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

Timeframe: 12 weeks

Trial details

NCT IDNCT05128942

SponsorSpruce Biosciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-31

Results submitted2025-09-18

View on ClinicalTrials.gov More Congenital Adrenal Hyperplasia trials