Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)

Launched by CRINETICS PHARMACEUTICALS INC. · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial, called TouCAHn, is studying a new medication named CRN04894 for people with a condition known as classic congenital adrenal hyperplasia (CAH), which is caused by a deficiency in a specific enzyme (21-hydroxylase). The main goals of the trial are to see if CRN04894 is safe, effective, and how the body processes the medication. This study is currently looking for participants aged 18 to 75 who have been diagnosed with classic 21-hydroxylase deficiency and are already on a stable treatment plan with glucocorticoids, which are hormones used to manage CAH.

If you decide to participate, you'll be closely monitored throughout the trial, and you'll receive the new medication while continuing your regular treatment. It’s important to note that there are some criteria that might exclude you from participating, such as having other forms of CAH, certain medical conditions, or recent significant health issues. This trial aims to improve treatment options for those living with CAH, and your involvement could help advance our understanding of this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female participants ≥18 to 75 years of age at the time of signing the Informed Consent Form (ICF). Participants ≥16 years of age may be included in sites located in the United States
• • 2. Classic 21-hydroxylase deficiency
• • 3. On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone)
• • 4. Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period
• • 5. Minimum total daily dose of ≥15 mg hydrocortisone (or equivalent). For Cohort 4, a mean daily dose of ≥11 mg/m²/day of hydrocortisone or hydrocortisone equivalents will be used for inclusion
• • 6. If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening
• Exclusion Criteria:
• • 1. Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
• • 2. Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4, dexamethasone is permitted
• • 3. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy
• • 4. Night shift workers or any other reason for abnormal sleep/wake cycles
• • 5. Clinically significant unstable medical condition or chronic disease other than CAH
• • 6. History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening
• • 7. Diabetes mellitus treated with insulin for less than 6 weeks prior to Screening, or with change in total daily insulin dose by \>15% within 6 weeks prior to Screening
• • 8. Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%(≥69 mmol/mL), or estimated HbA1c based on fructosamine if HbA1c is not evaluable (eg, due to hemoglobinopathies)
• • 9. Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening
• • 10. History of unstable angina or acute myocardial infarction within 12 weeks prior to Screening or other clinically significant cardiac disease at the time of Screening
• • 11. History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
• • 12. Pregnant or lactating
• • 13. Known history of illicit drug or alcohol abuse within the last year
• • 14. Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide)
• • 15. Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone