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A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Sponsor: Crinetics Pharmaceuticals Inc.
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).
Official title: A Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants With Congenital Adrenal Hyperplasia Including a Long-Term Extension
Key Details
Gender
All
Age Range
1 Year - 17 Years
Study Type
INTERVENTIONAL
Enrollment
153
Start Date
2026-01-22
Completion Date
2030-03
Last Updated
2026-04-08
Healthy Volunteers
No
Interventions
Atumelnant
Atumelnant, tablets, once daily by mouth, weight-based dosing
Placebo
Placebo, tablets, once daily by mouth, weight-based dosing
Locations (24)
University of Michigan
Ann Arbor, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Cook Children's Health Care System
Fort Worth, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Instituto de Investigaciones Metabólicas
Buenos Aires, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Instituto Médico Especializado (IME)
Buenos Aires, Argentina
Institute of Endocrinology of Diabetes, The Children's Hospital at Westmead
Westmead, New South Wales, Australia
Queensland Children's Hospital
South Brisbane, Queensland, Australia
Monash Children's Hospital, Monash Health
Clayton, Victoria, Australia
UZ Gent (University Hospital Ghent)
Ghent, East Flanders, Belgium
UZ Leuven (Universitair Ziekenhuis Leuven)
Leuven, Flemish Brabant, Belgium
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP)
São Paulo, São Paulo, Brazil
Hopital Kremlin-Bicétre - APHP Paris Saclay
Le Kremlin-Bicêtre, France
APHM -Hopital La Timone Enfants
Marseille, France
Hopital Robert Debre
Paris, France
AOU Federico II
Naples, Campania, Italy
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, Italy
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Tuscany, Italy
lnstytut Centrum Zdrowia Matki Polki, Klinika Endokrynologii i Chor6b Metabolicznych
Lodz, Poland, Poland
Uniwersytecki Szpital Kliniczny Nr 1 im. Prof. Tadeusza Sokotowskiego PUM w Szczecinie, Centrum Wsparcia Badan Klinicznych Pomorskiego Uniwersytetu Medycznego w Szczecinie
Szczecin, West Pomeranian Voivodeship, Poland
Sheffield Children's Hospital NHS Trust, Sheffield Children's Hospital, Western Bank
Sheffield, United Kingdom