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RECRUITING
NCT07159841
PHASE2/PHASE3

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

Sponsor: Crinetics Pharmaceuticals Inc.

View on ClinicalTrials.gov

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

DRUG

Atumelnant

Atumelnant, tablets, once daily by mouth, weight-based dosing

DRUG

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