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A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)

StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Study sites: 48 to 49
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 8 entries
    • Study description revised
  2. Trial sites expanded: 44 → 48 locationsv20
  3. Study sites: 43 to 44v19
  4. Trial sites expanded: 37 → 43 locationsv18
  5. Study sites: 35 to 37v17
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  1. Study sites: 33 to 35v16
  2. Study sites: 32 to 33
    • Eligibility criteria shortened, about 12 words
    • Secondary endpoints revised (8)
    • Study description revised
    v15
  1. Trial sites expanded: 24 → 32 locationsv14
  2. Trial sites expanded: 18 → 24 locationsv13
  3. Study sites: 15 to 18v12
  4. Study sites revised (15)v11
  5. Study sites: 14 to 15
    • Start date changed from estimate of Jan 31, 2026 to Jan 22, 2026
    v10
  6. Study sites: 13 to 14v9
  7. Study sites: 12 to 13v8
  8. Site details revised at 3 of 12 sitesv7
  9. Study sites: 9 to 12v6
  10. Site details revised at 1 of 9 sitesv5
  11. Study sites: 8 to 9v4
  12. Start date: Nov 30, 2025 to Jan 31, 2026
    • Study sites: 6 to 8
    v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Sep 2025 to Nov 30, 2025
    • Study sites: 0 to 6
    v2
  14. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07159841
Lead Sponsor Crinetics Pharmaceuticals Inc.
Conditions
(from sponsor)		 Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
Related terms Adrenal Hyperplasia, Congenital
Enrollment 153 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov