drugset / Trial / NCT05128942
A Phase 2 Study to Evaluate the Safety, Efficacy and PK of Tildacerfont in Children Aged 2-17 Years With CAH
Non-randomizedSequentialOpen-labelTreatment
Summary
An investigation of the safety and efficacy of tildacerfont in participants with CAH.
Timeline
- Start
- 2021-12-10
- Primary completion
- 2025-01-31
- Completion
- 2025-01-31
Outcome
Outcome not reported
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.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tildacerfont | Small molecule | 50 mg | Oral |
| Subject | Tildacerfont | Small molecule | 100 mg | Oral |
| Subject | Tildacerfont | Small molecule | 200 mg | Oral |
| Subject | Tildacerfont | Small molecule | 300 mg | Oral |
| Subject | Tildacerfont | Small molecule | 400 mg | Oral |