NCT05907291

Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

A 12-week, Phase 2 Open-label, Sequential Dose Cohort Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 Treatment in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Crinetics Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 16 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of atumelnant (CRN04894) in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.

Detailed description

This Phase 2, open-label, sequential dose cohort study will evaluate the efficacy, safety, PK, and PD of atumelnant (CRN04894) when administered for 12 weeks in participants with CAH caused by 21-hydroxylase deficiency. Up to 42 participants will be enrolled in the study.

Conditions

• Congenital Adrenal Hyperplasia
• Classic Congenital Adrenal Hyperplasia

Interventions

Type	Name	Description
DRUG	atumelnant (CRN04894)	Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.

Timeline

• Start date: 2023-07-03
• Primary completion: 2025-08-22
• Completion: 2025-08-22
• First posted: 2023-06-18
• Last updated: 2025-09-23

Locations

27 sites across 7 countries: United States, Argentina, Brazil, Germany, India, Italy, United Kingdom

Regulatory

• FDA-regulated drug study