Evaluate the Safety, Efficacy, and Pharmacokinetics of CRN04894 in Participants With Congenital Adrenal Hyperplasia (TouCAHn)
Completed · Phase 2
Conditions studied: Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
In brief
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.
Key facts
- Study ID
- NCT05907291
- Run by
- Crinetics Pharmaceuticals Inc.
- People needed
- 38
- Starts
- 2023-07-03
- Expected to finish
- 2025-08-22
- Last updated by the study team
- 2025-09-23
Who can join
Age: 16 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- 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)
- Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening
- 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
- History of cancer excluding cured/treated dermal squamous or basal cell carcinoma or cervical carcinoma in situ
- Pregnant or lactating
- Known history of illicit drug or alcohol abuse within the last year
- Use of antiandrogen therapy in the past 3 months (eg, spironolactone, finasteride, cyproterone acetate, flutamide)
- Use of testosterone, androgen-containing supplements, aromatase inhibitors, or growth hormone
Where it is running
- Crinetics Study Site — Naples, Italy
- Crinetics Study Site — Roma, Italy
- Crinetics Study Site — Rozzano, Italy
- Crinetics Study Site — Pasadena, California, United States
- Crinetics Study Site — Ann Arbor, Michigan, United States
- Crinetics Study Site — Minneapolis, Minnesota, United States
- Crinetics Study Site — St Louis, Missouri, United States
- Crinetics Study Site — Morehead City, North Carolina, United States
- Crinetics Study Site — Cleveland, Ohio, United States
- Crinetics Study Site — Philadelphia, Pennsylvania, United States
- Crinetics Study Site — East Providence, Rhode Island, United States
- Crinetics Study Site — Córdoba, Córdoba Province, Argentina
- Crinetics Study Site — Buenos Aires, Argentina
- Crinetics Study Site — Curitiba, Paraná, Brazil
- Crinetics Study Site — Rio de Janeiro, Rio de Janeiro, Brazil
- Crinetics Study Site — Rio de Janeiro, Rio de Janeiro, Brazil
- Crinetics Study Site — Porto Alegre, Rio Grande do Sul, Brazil
- Crinetics Study Site — Botucatu, São Paulo, Brazil
- Crinetics Study Site — Ribeirão Preto, São Paulo, Brazil
- Crinetics Study Site — São Paulo, São Paulo, Brazil
- Crinetics Study Site — São Paulo, Brazil
- Crinetics Study Site — Munich, Bavaria, Germany
- Crinetics Study Site — Bangalore, Karnataka, India
- Crinetics Study Site — Vellore, Tamil Nadu, India
- Crinetics Study Site — Sheffield, South Yorkshire, United Kingdom
Full record on ClinicalTrials.gov
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