NCT03687242

Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia

A 3-Month Phase 2 Study to Evaluate the Safety and Efficacy of SPR001 in Subjects With Classic Congenital Adrenal Hyperplasia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Spruce Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 study of SPR001 for the treatment of classic CAH that will provide 12 weeks of open-label treatment to eligible subjects.

Detailed description

This is a Phase 2 study of SPR001 for the treatment of classic CAH that will provide 12 weeks of open-label treatment to eligible subjects. To be eligible for this study, an individual must either have completed Study SPR001-201 or meet eligibility criteria for SPR001-naïve subjects. The expected duration of study participation for each subject is up to approximately 5 months. This includes a screening period of ≤30 days, a treatment period of 12 weeks, and a safety follow-up period of 30 days.

Conditions

• Congenital Adrenal Hyperplasia
• CAH - Congenital Adrenal Hyperplasia
• CAH - 21-Hydroxylase Deficiency

Interventions

Type	Name	Description
DRUG	SPR001	Open label SPR001

Timeline

• Start date: 2018-09-06
• Primary completion: 2019-07-08
• Completion: 2019-08-09
• First posted: 2018-09-27
• Last updated: 2025-04-01
• Results posted: 2025-04-01

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study