Actively Recruiting
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Led by Crinetics Pharmaceuticals Inc. · Updated on 2026-04-30
153
Participants Needed
32
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female at birth, aged 1 to under 18 years at consent
- Medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency by accepted criteria
- Elevated morning serum androstenedione (A4) above upper limit of normal before morning glucocorticoid dose
- Stable supraphysiologic glucocorticoid replacement therapy for at least one month before screening
- Compliance with glucocorticoid and mineralocorticoid replacement therapy as judged by investigator
- Normal thyroid stimulating hormone and thyroxine levels within 3 months before screening
- For Part C, completed Part A or B treatment and investigator believes continuing would benefit the participant
You will not qualify if you...
- Diagnosis of any form of CAH other than classic 21-hydroxylase deficiency
- Treatment with other glucocorticoids within 30 days before screening
- Stress-dose glucocorticoid therapy within 2 weeks before screening
- Use of growth hormones within 1 week (short acting) or 6 weeks (long acting) before screening
- Use of corticotropin-releasing factor receptor antagonist within 14 days before screening
- History of cancer except cured skin or cervical carcinoma in situ
- Abnormal sleep/wake cycles as determined by investigator
- Female participants who are pregnant or breastfeeding
- Use of investigational drugs (other than atumelnant) within 60 days or 5 half-lives before first dose
- For Part C, not meeting Part C inclusion criteria
AI-Screening
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Trial Site Locations
Total: 32 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
3
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
Cook Children's Health Care System
Fort Worth, Texas, United States, 76104
Actively Recruiting
6
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Actively Recruiting
7
Instituto de Investigaciones Metabólicas
Buenos Aires, Buenos Aires, Argentina, C1012AAR
Actively Recruiting
8
Hospital de Niños de la Santísima Trinidad
Córdoba, Córdoba Province, Argentina, X5000
Actively Recruiting
9
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199ABB
Actively Recruiting
10
Instituto Médico Especializado (IME)
Buenos Aires, Argentina, C1405BCH
Actively Recruiting
11
CEDIE "Centro de Investigaciones Endocrinológicas", CONICET-FEI División de Endocrinología, Hosp de Niños Ricardo Gutiérrez
Buenos Aires, Argentina, C1425EFD
Actively Recruiting
12
Institute of Endocrinology of Diabetes, The Children's Hospital at Westmead
Westmead, New South Wales, Australia, 2145
Not Yet Recruiting
13
Queensland Children's Hospital
South Brisbane, Queensland, Australia, 4101
Not Yet Recruiting
14
Monash Children's Hospital, Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
15
UZA (Antwerp University Hospital)
Edegem, Antwerp, Belgium, 2650
Actively Recruiting
16
UZ Gent (University Hospital Ghent)
Ghent, East Flanders, Belgium, 9000
Actively Recruiting
17
UZ Leuven (Universitair Ziekenhuis Leuven)
Leuven, Flemish Brabant, Belgium, 3000
Actively Recruiting
18
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP)
São Paulo, São Paulo, Brazil, 05403-000
Actively Recruiting
19
Centre Hospitalier Universitaire (CHU) d'Angers
Angers, France, 49100
Actively Recruiting
20
Hopital Kremlin-Bicétre - APHP Paris Saclay
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
21
Hopital Jeanne de Flandre - CHU de Lille
Lille, France, 59037
Actively Recruiting
22
APHM -Hopital La Timone Enfants
Marseille, France, 13385 Cedex 5
Actively Recruiting
23
Hopital Necker - Enfants Malades
Paris, France, 75015
Actively Recruiting
24
Hopital Robert Debre
Paris, France, 75019
Actively Recruiting
25
Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für pädiatrische Endokrinologie und Diabetologie
Berlin, Germany, 13353
Actively Recruiting
26
AOU Federico II
Naples, Campania, Italy, 80131
Actively Recruiting
27
IRCCS Istituto Giannina Gaslini
Genoa, Liguria, Italy, 16147
Actively Recruiting
28
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
29
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence, Tuscany, Italy, 50139
Actively Recruiting
30
lnstytut Centrum Zdrowia Matki Polki, Klinika Endokrynologii i Chor6b Metabolicznych
Lodz, Poland, Poland, 93-338
Actively Recruiting
31
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, 71-252
Actively Recruiting
32
Sheffield Children's Hospital NHS Trust, Sheffield Children's Hospital, Western Bank
Sheffield, United Kingdom, S10 2TH
Actively Recruiting
Research Team
C
Crinetics Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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