Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital A… (NCT05907291) | Clinical Trial Compass
CompletedPhase 2
Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)
United States38 participantsStarted 2023-07-03
Plain-language summary
The purpose of this Phase 2, open-label, sequential dose cohort study is to evaluate the safety, efficacy, and pharmacokinetics (PK) of atumelnant (CRN04894) in participants with classic congenital adrenal hyperplasia (CAH) caused by 21-hydroxylase deficiency.
Who can participate
Age range16 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
✓. Classic 21-hydroxylase deficiency
✓. On a stable regimen of glucocorticoid replacement (eg, hydrocortisone, prednisolone, prednisone, methylprednisolone)
✓. Compliance with glucocorticoid replacement and mineralocorticoid replacement (if applicable) regimen during the Screening Period
✓. 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
✓. If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening
Exclusion criteria
✕. Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
✕. Dexamethasone use within 30 days of Screening for Cohorts 1-3. In Cohort 4, dexamethasone is permitted
✕. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy
✕. Night shift workers or any other reason for abnormal sleep/wake cycles
✕. Clinically significant unstable medical condition or chronic disease other than CAH
What they're measuring
1
Change from baseline in morning (before 11:00) serum androstenedione (A4)
Timeframe: Week 12
2
Incidence of treatment-emergent adverse events (TEAEs) throughout the study
✕. History of major surgery/surgical therapy for any cause within 4 weeks prior to Screening
✕. 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
✕. 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)