Estudio de Fase 2, Abierto, de Cohortes Secuenciales de D... | EligiMed

Estudio de Fase 2, Abierto, de Cohortes Secuenciales de Dosis de 12 Semanas para Evaluar la Seguridad, Eficacia y Farmacocinética del Tratamiento con CRN04894 en Participantes con Hiperplasia Suprarrenal Congénita (TouCAHn)

CompletadoFase 2ClinicalTrials.gov

ID: NCT05907291Tipo: INTERVENTIONALInicio: 3 de jul de 2023Fin estimado: 22 de ago de 2025

Resumen

El objetivo de este estudio de fase 2, abierto, de cohortes secuenciales de dosis es evaluar la seguridad, eficacia y farmacocinética (FK) de atumelnant (CRN04894) en participantes con hiperplasia suprarrenal congénita (HSC) clásica causada por deficiencia de 21-hidroxilasa.

Descripción detallada

Este estudio de fase 2, abierto, de cohortes secuenciales de dosis evaluará la eficacia, seguridad, FK y farmacodinámica (FD) de atumelnant (CRN04894) administrado durante 12 semanas en participantes con HSC causada por deficiencia de 21-hidroxilasa. Se inscribirán hasta 42 participantes en el estudio.

Elegibilidad

Edad mínima: 16 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

atumelnant (CRN04894)

Atumelnant is an orally active nonpeptide melanocortin 2 receptor (MC2R) or adrenocorticotropic hormone (ACTH) antagonist.

Ubicaciones

Crinetics Study Site

Córdoba, Córdoba Province, Argentina

Crinetics Study Site

Buenos Aires, Argentina

Patrocinadores

PrincipalCrinetics Pharmaceuticals Inc.

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