A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Recruiting
Phase 2
Phase 3
Interventional Study
Congenital Adrenal Hyperplasia
Classic Congenital Adrenal Hyperplasia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 – 17
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 153 (estimated)
- Sponsor
- Crinetics Pharmaceuticals Inc. · Industry
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About This Trial
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).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Part A and B participants are eligible to be included in the study only if all of the following criteria apply:
1. Male or female at birth, between 1 to \<18 years of chronological age at the time of signing the Informed Consent Form (ICF).
2. Have a medically confirmed diagnos…
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