Clinical Trials in Japan / NCT07144163
Recruiting
Phase 3
A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia
NCT07144163 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Congenital Adrenal HyperplasiaClassic Congenital Adrenal Hyperplasia
Investigational drug(s) / intervention(s)
Atumelnant →Placebo
Atumelnant: Atumelnant, tablets, once daily by mouth
Placebo: Placebo, tablets, once daily by mouth
Study summary
The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.
Eligibility
Inclusion Criteria:
1. Male or female, between ≥18 to \<75 years of age at the time of signing the ICF.
2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.
3. Have classic CAH due to 21-OHD confirmed by the Investigator.
4. Participants with Visit 2 levels of morning serum A4 as follows:
* A4 \>ULN and treated with \<11 mg/m2/day (physiologic) GC doses
* OR normal A4 (\>0.5xULN to ≤1xULN) and treated with ≥14 mg/m2/day GC doses
* OR A4 \>ULN and treated with ≥11 mg/m2/day GC doses.
5. On a stable (defined as no dose change of \>5 mg/day hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.
6. If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.
7. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.
Exclusion Criteria:
1. Diagnosis of any form of CAH other than classic 21-OHD.
2. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.
3. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.
4. Concomitant mental condition rendering him/her unable to understand the nature, scope, and possible consequences of the study, and/or evidence of poor compliance with medical instructions.
5. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.
6. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.
7. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.
8. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.
9. Severe erythrocytosis as judged by the Investigator.
10. Use of atumelnant prior to screening.
Primary outcome measure(s)
- Proportion of participants with morning post-GC A4 ≤ ULN who are on physiologic GC replacement. — Week 32
Trial sites (75)
| Facility | City | Region | Status |
|---|---|---|---|
| Crinetics Study Site | Los Angeles | California | Recruiting |
| Crinetics Study Site | Aurora | Colorado | Recruiting |
| Crinetics Study Site | Gainesville | Florida | Recruiting |
| Crinetics Study Site | Atlanta | Georgia | Recruiting |
| Crinetics Study Site | Chicago | Illinois | Recruiting |
| Crinetics Study Site | Baltimore | Maryland | Recruiting |
| Crinetics Study Site | Ann Arbor | Michigan | Recruiting |
| Crinetics Study Site | Minneapolis | Minnesota | Recruiting |
| Crinetics Study Site | Rochester | Minnesota | Recruiting |
| Crinetics Study Site | Philadelphia | Pennsylvania | Recruiting |
| Crinetics Study Site | Pittsburgh | Pennsylvania | Recruiting |
| Crinetics Study Site | Dallas | Texas | Recruiting |
| Crinetics Study Site | Milwaukee | Wisconsin | Recruiting |
| Crinetics Study Site | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Crinetics Study Site | Buenos Aires | Buenos Aires F.D. | Recruiting |
| Crinetics Study Site | CABA | Buenos Aires F.D. | Recruiting |
| Crinetics Study Site | CABA | Buenos Aires F.D. | Recruiting |
| Crinetics Study Site | Córdoba | Córdoba Province | Recruiting |
| Crinetics Study Site | Herston | Queensland | Recruiting |
| Crinetics Study Site | Woolloongabba | Queensland | Recruiting |
| Crinetics Study Site | Adelaide | South Australia | Recruiting |
| Crinetics Study Site | Parkville | Victoria | Recruiting |
| Crinetics Study Site | Nedlands | Western Australia | Recruiting |
| Crinetics Study Site | Graz | Styria | Recruiting |
| Crinetics Study Site | Vienna | Austria | Recruiting |
| Crinetics Study Site | Fortaleza | Ceará | Recruiting |
| Crinetics Study Site | Brasília | Federal District | Recruiting |
| Crinetics Study Site | Belo Horizonte | Minas Gerais | Recruiting |
| Crinetics Study Site | Curitiba | Paraná | Recruiting |
| Crinetics Study Site | Rio de Janeiro | Rio de Janeiro | Recruiting |
| Crinetics Study Site | Rio de Janeiro | Rio de Janeiro | Recruiting |
| Crinetics Study Site | Porto Alegre | Rio Grande do Sul | Recruiting |
| Crinetics Study Site | Botucatu | São Paulo | Recruiting |
| Crinetics Study Site | Campinas | São Paulo | Recruiting |
| Crinetics Study Site | Ribeirão Preto | São Paulo | Recruiting |
| Crinetics Study Site | São Paulo | São Paulo | Recruiting |
| Crinetics Study Site | São Paulo | São Paulo | Recruiting |
| Crinetics Study Site | Halifax | Nova Scotia | Recruiting |
| Crinetics Study Site | Angers | France | Recruiting |
| Crinetics Study Site | Bron | France | Recruiting |
+ 35 more sites — see the full list on the official registry below.
Official registry record
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 NCT07144163 on ClinicalTrials.gov ↗ ← All trials in Japan