A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
NCT07159841 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 153
Last updated 2026-04-30
Summary
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
Conditions
- Congenital Adrenal Hyperplasia
- Classic Congenital Adrenal Hyperplasia
Interventions
- DRUG
-
Atumelnant
Atumelnant, tablets, once daily by mouth, weight-based dosing
- DRUG
-
Placebo, tablets, once daily by mouth, weight-based dosing
Sponsors & Collaborators
-
Crinetics Pharmaceuticals Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 1 Year
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-01-22
- Primary Completion
- 2030-03-31
- Completion
- 2030-03-31
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Australia
- Belgium
- Brazil
- France
- Germany
- Italy
- Poland
- United Kingdom
Study Locations
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