A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Condition(s) studied
Investigational drug(s) / intervention(s)
Atumelnant: Atumelnant, tablets, once daily by mouth, weight-based dosing
Placebo: Placebo, tablets, once daily by mouth, weight-based dosing
Study 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).
Eligibility
Primary outcome measure(s)
- Change from baseline in morning serum androstenedione (A4) (Part A) — Week 8
- Percent change from baseline in glucocorticoid (GC) daily dose while serum early morning A4 ≤Upper Limit of Normal (ULN) (Part B) — Week 28
- Change from baseline in serum early morning A4 over time (Part C) — Up to Week 260
Trial sites (49)
| Facility | City | Region | Status |
|---|---|---|---|
| UCSF Ron Conway Gateway Medical Building | San Francisco | California | Recruiting |
| Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | Recruiting |
| Boston's Children's Hospital | Boston | Massachusetts | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Rutgers Robert Wood Johnson Medical School | New Brunswick | New Jersey | Recruiting |
| Icahn School of Medicine at Mount Sinai-Mount Sinai Hospital | New York | New York | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | Recruiting |
| Cook Children's Health Care System | Fort Worth | Texas | Recruiting |
| University of Virginia Health System | Charlottesville | Virginia | Recruiting |
| Instituto de Investigaciones Metabólicas | Buenos Aires | Buenos Aires | Recruiting |
| Hospital de Niños de la Santísima Trinidad | Córdoba | Córdoba Province | Recruiting |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina | Recruiting |
| Instituto Médico Especializado (IME) | Buenos Aires | Argentina | Recruiting |
| CEDIE "Centro de Investigaciones Endocrinológicas", CONICET-FEI División de Endocrinología, Hosp de Niños Ricardo Gutiérrez | Buenos Aires | Argentina | Recruiting |
| Institute of Endocrinology of Diabetes, The Children's Hospital at Westmead | Westmead | New South Wales | Not Yet Recruiting |
| Queensland Children's Hospital | South Brisbane | Queensland | Not Yet Recruiting |
| Monash Children's Hospital, Monash Health | Clayton | Victoria | Recruiting |
| Perth Children's Hospital | Nedlands | Western Australia | Not Yet Recruiting |
| UZA (Antwerp University Hospital) | Edegem | Antwerp | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Brussels Capital | Recruiting |
| UZ Gent (University Hospital Ghent) | Ghent | East Flanders | Recruiting |
| UZ Leuven (Universitair Ziekenhuis Leuven) | Leuven | Flemish Brabant | Recruiting |
| Nucleo de Pesquisa Clinica do Rio Grande do Sul | Porto Alegre | Rio Grande do Sul | Recruiting |
| Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo | Ribeirão Preto | São Paulo | Recruiting |
| Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HCFMUSP) | São Paulo | São Paulo | Recruiting |
| Instituto de Investigaciones Materno Infantil IDIMI, Facultad de Medicina de la Universidad de Chile | Santiago | Santiago Metropolitan | Recruiting |
| Hospital las Hilgueras de Talcahuano | Talcahuano | Chile | Recruiting |
| Centre Hospitalier Universitaire (CHU) d'Angers | Angers | France | Recruiting |
| Hopital Kremlin-Bicétre - APHP Paris Saclay | Le Kremlin-Bicêtre | France | Recruiting |
| Hopital Jeanne de Flandre - CHU de Lille | Lille | France | Recruiting |
| APHM -Hopital La Timone Enfants | Marseille | France | Recruiting |
| Hopital Necker - Enfants Malades | Paris | France | Recruiting |
| Hopital Robert Debre | Paris | France | Recruiting |
| Universitätsklinikum Tübingen Klinik fur Kinder und Jugendmedizin | Tübingen | Baden | Recruiting |
| Universitatsklinikum Koln Klinik und Poliklinik fur Kinder- und Jugendmedizin | Cologne | North Rhine-Westphalia | Recruiting |
| Charité - Universitätsmedizin Berlin Campus Virchow-Klinikum Klinik für pädiatrische Endokrinologie und Diabetologie | Berlin | Germany | Recruiting |
| AOU Federico II | Naples | Campania | Recruiting |
| IRCCS Istituto Giannina Gaslini | Genoa | Liguria | Recruiting |
| IRCCS Ospedale San Raffaele | Milan | Lombardy | Recruiting |
+ 9 more sites — see the full list on the official registry below.
More Crinetics Pharmaceuticals Inc. trials in Belgium
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07159841 on ClinicalTrials.gov ↗ ← All trials in Belgium