Actively Recruiting
An Open-label, Long-term Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894
Led by Crinetics Pharmaceuticals Inc. · Updated on 2025-09-23
150
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are assessing the long-term safety, tolerability, and effectiveness of atumelnant (CRN04894) in people with congenital adrenal hyperplasia (CAH). This open-label, single-arm extension study enrolls participants who have already completed earlier studies with atumelnant and who are judged by investigators to benefit from continued treatment. About 150 participants are expected to take part in this Phase 2 trial. Participants will receive atumelnant orally, with dosing up to the highest level previously tested in earlier studies for CAH. The treatment period may last up to two years, during which participants will continue to take stable doses of glucocorticoid replacement therapy such as hydrocortisone or equivalent. The study focuses on continued monitoring of safety and effectiveness as participants use atumelnant over this extended timeframe. Throughout the study, participants will have regular assessments including blood tests to measure hormone levels like androstenedione and 17-hydroxyprogesterone, monitoring for adverse events, and evaluations of glucocorticoid doses. Researchers will track hospitalizations related to CAH, adrenal crises, and other safety outcomes up to week 108. This long-term approach aims to provide detailed information about the impact of atumelnant on participant health and disease management over time.
CONDITIONS
Brief Title
An Extension Study to Evaluate Safety and Efficacy in Participants Treated With CRN04894
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with congenital adrenal hyperplasia (CAH) who have completed a previous Crinetics CRN04894 study and are judged to benefit from continued dosing
- Participants must be compliant with a stable glucocorticoid replacement regimen at the time of informed consent
- Female participants engaging in heterosexual intercourse must be of nonchildbearing potential, postmenopausal, or agree to use effective contraception
- Male participants must agree to use condoms with female partners of childbearing potential or be surgically sterile or abstinent
- Participants must be aged 16 years or older
You will not qualify if you...
- Any medical condition or lab finding that risks participant safety or study completion
- Known history or current alcohol or drug abuse within the past 12 months
- Mental conditions impairing understanding or compliance
- Allergy or hypersensitivity to study materials or high risk of adrenal insufficiency
- Pregnant or lactating women or those unwilling to use effective contraception
- Employees or immediate family of Crinetics Pharmaceuticals
- Use of investigational drugs other than atumelnant within 60 days before consent
- History of cancer except certain treated skin or cervical cancers
- Institutionalized by judicial or administrative order
- Significant abnormal lab tests or diseases other than CAH, including cardiovascular disease, moderate/severe kidney or liver disease
- History of bilateral adrenalectomy, hypopituitarism, or chronic glucocorticoid therapy
- Major surgery within 4 weeks prior to screening
- Poorly controlled diabetes mellitus (HbA1c ≥8.5%)
- Untreated hypothyroidism
- Certain abnormal ECG findings at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants receive atumelnant (CRN04894) to evaluate safety, tolerability, and efficacy in congenital adrenal hyperplasia (CAH).
Trial Site Locations
Total: 9 locations
1
Crinetics Study Site, Minneapolis, Minnesota 55454
Minneapolis, Minnesota, United States, 55455
Active, Not Recruiting
2
Crinetics Study Site
Morehead City, North Carolina, United States, 28557
Active, Not Recruiting
3
Crinetics Study Site
Córdoba, Córdoba Province, Argentina, 5000
Actively Recruiting
4
Crinetics Study Site
Botucatu, São Paulo, Brazil, 18618-686
Actively Recruiting
5
Crinetics Study Site
São Paulo, Brazil, 05403-000
Actively Recruiting
6
Crinetics Study Site
Munich, Bavaria, Germany, 80336
Actively Recruiting
7
Crinetics Study Site
Roma, Italy, 00161
Actively Recruiting
8
Crinetics Study Site
Birmingham, United Kingdom, CV22DX
Actively Recruiting
9
Crinetics Study Site
London, United Kingdom, NW1 2BU
Actively Recruiting
Research Team
C
Crinetics Clinical Trials Crinetics Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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