Last updated 30 days ago

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

30 patients around the world

Available in Argentina, United States

This Phase 2, open-label, sequential dose cohort study will evaluate the efficacy, safety, PK, and PD of CRN04894 when administered for 12 weeks in participants with CAH caused by 21-hydroxylase deficiency. Up to approximately 30 participants will be enrolled in the study.

Crinetics Pharmaceuticals Inc.

30Patients around the world

Requirements for the patient

To 75 Years

All Gender

Medical requirements

: 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)
If on estrogen therapy (any route), dose must be stable for at least 3 months prior to Screening

: Diagnosis of any other form of CAH other than classic 21-hydroxylase deficiency
Dexamethasone use within 30 days of Screening
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

SponsorCrinetics Pharmaceuticals Inc.

Requirements

To 75 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05907291