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

Part of paid clinical trials in San Francisco, California.

Sponsor
Crinetics Pharmaceuticals Inc.
Study ID
NCT07159841
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Classic Congenital Adrenal Hyperplasia
  • Congenital Adrenal Hyperplasia

Eligibility Criteria

Sex
ALL
Age
1 Year - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Atumelnant — DRUG
    Atumelnant, tablets, once daily by mouth, weight-based dosing
  • Placebo — DRUG
    Placebo, tablets, once daily by mouth, weight-based dosing

Study Details

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).

Key Dates

First listed
Sep 8, 2025
Start date
Jan 22, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2030
Completion
Mar 31, 2030

Study Design

Enrollment
153 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Part A)
    Open-label, semi-sequential cohorts.
  • Experimental: Active Treatment (Part B)
    Randomized, Parallel Arms, Double-Blind
  • Placebo Comparator: Placebo (Part B)
    Randomized, Parallel Arms, Double-Blind
  • Experimental: Open-Label Treatment (Part C)
    Open-label treatment period for participants entering Part C from Part A and B.

Primary Outcome Measure

Change from baseline in morning serum androstenedione (A4) (Part A) [ Time Frame: Week 8 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
UCSF Ron Conway Gateway Medical BuildingSan FranciscoCalifornia94158-
Boston's Children's HospitalBostonMassachusetts02115-
University of MichiganAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55454-
Rutgers Robert Wood Johnson Medical SchoolNew BrunswickNew Jersey08901-
Icahn School of Medicine at Mount Sinai-Mount Sinai HospitalNew YorkNew York10029-
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104-
Cook Children's Health Care SystemFort WorthTexas76104-
University of Virginia Health SystemCharlottesvilleVirginia22903-

Find similar trials in San Francisco, CA

By research site
UCSF Ron Conway Gateway Medical Building· San Francisco, CABoston's Children's Hospital· Boston, MAUniversity of Michigan· Ann Arbor, MIUniversity of Minnesota· Minneapolis, MNRutgers Robert Wood Johnson Medical School· New Brunswick, NJIcahn School of Medicine at Mount Sinai-Mount Sinai Hospital· New York, NY

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