Estudio de fase 2, aleatorizado, doble ciego, controlado con placebo, de determinación de rango de dosis, multicéntrico, para evaluar la eficacia, seguridad y farmacocinética de ALXN2420, un antagonista del receptor de la hormona de crecimiento, administrado por vía subcutánea en combinación con análogos de la somatostatina en participantes adultos con acromegalia.

ReclutandoFase 2ClinicalTrials.gov

ID: NCT07037420Tipo: INTERVENTIONALInicio: 28 de oct de 2025Fin estimado: 11 de nov de 2027

Resumen

El objetivo primario de este estudio es evaluar la eficacia del tratamiento de 15 semanas con ALXN2420 versus placebo para reducir los niveles del factor de crecimiento similar a la insulina IGF-1, cuando se administra en combinación con la terapia con análogos de la somatostatina (SSA) en participantes adultos con acromegalia.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Documented diagnosis of acromegaly, that is, historically documented evidence of a GH-secreting pituitary adenoma based on MRI or pathology report
Must be receiving maximum, or maximally tolerated dose per treating physician judgment, of long-acting SSAs (octreotide or lanreotide LAR) and meet both of the following:
Received for ≥ 6 months prior to screening
Receiving a once-monthly regimen (approximately every 4 weeks). Note: participants on stable regimens of other durations (for example, every 3 or 6 weeks) are not eligible
Must be a partial responder to SSAs defined as \> 20% relative IGF 1 reduction during the course of SSA therapy
Serum IGF-1 levels \> 1.3 to 5\*ULN inclusive, as assessed at a central laboratory and adjusted for age and sex, based on average of 2 consecutive values obtained during the Screening Period and obtained ≥ 7 days apart

Criterios de exclusión

Had surgery for pituitary adenoma within the last 6 months before Day 1 or planning to receive surgery for pituitary adenoma during the study
Pituitary adenoma that, per Investigator's judgment, is worsening as assessed by pituitary/sellar MRI or computed tomography scan obtained ≤ 6 months prior to screening
Pituitary adenoma causing compression of the chiasm
Clinical evidence of symptomatic hyperprolactinemia that would necessitate treatment with dopamine agonists
Known hypothyroidism or hypocortisolism not adequately treated with a stable dose of thyroid or glucocorticoid hormone replacement therapy for ≥ 3 months prior to Screening
Active, clinically significant cardiac disease as judged by the Investigator
History of unstable angina, stroke, or acute myocardial infarction ≤ 3 months prior to screening
Known uncontrolled type 2 diabetes (HbA1c \> 10%)
Active malignant disease ≤ 2 years prior to screening with exception of basal and squamous cell carcinoma of the skin
Received any type of fractionated radiotherapy or a second surgical adenectomy for pituitary adenoma within the last 3 years (5 years for conventional radiation) before starting treatment and/or are planning to receive radiotherapy or a second surgical adenectomy during the study
Received pegvisomant ≤ 8 weeks prior to screening
Received dopamine agonists ≤ 4 weeks prior to screening
Received pasireotide LAR ≤ 4 months prior to screening
Clinically significant renal or hepatic disease at the time of screening, as judged by the Investigator
eGFR (CKD-EPI formula) \< 30 mL/minute/1.73 m\^2 documented based on recent value (\< 3 months prior to randomization)
Clinically significant abnormal values for hematology, biochemistry, coagulation, or urinalysis, as judged by the Investigator, including, but not limited to, total bilirubin \> 1.5\*ULN (except if in free bilirubin linked to a known Gilbert Syndrome) or AST, ALT, or alkaline phosphatase \> 2\*ULN

Intervenciones

drug

ALXN2420

ALXN2420 will be administered via subcutaneous (SC) injection

drug

Placebo

Placebo will be administered via SC injection.

Ubicaciones

Research Site

CABA, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, Argentina

RECRUITING

Patrocinadores

PrincipalAlexion Pharmaceuticals, Inc.

Contactos

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

clinicaltrials@alexion.com 1-855-752-2356

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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