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

> **NCT05128942** · PHASE2 · TERMINATED · sponsor: **Spruce Biosciences** · enrollment: 67 (actual)

## Conditions studied

- Congenital Adrenal Hyperplasia
- 21-OHD

## Interventions

- **DRUG:** Tildacerfont

## Key facts

- **NCT ID:** NCT05128942
- **Lead sponsor:** Spruce Biosciences
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2021-12-10
- **Primary completion:** 2025-01-31
- **Final completion:** 2025-01-31
- **Target enrollment:** 67 (ACTUAL)
- **Why 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.
- **Last updated:** 2025-12-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05128942

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05128942, "A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT05128942. Licensed CC0.

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