Estudio de fase 2, aleatorizado, ciego, controlado con placebo para evaluar la seguridad, tolerabilidad, farmacométrica y eficacia de DNTH103 en adultos con miastenia grave generalizada (MAGIC)

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT06282159RENIS: IS004852Tipo: INTERVENTIONALInicio: 23 de feb de 2024Fin estimado: 1 de ago de 2027

Resumen

El propósito de este estudio de fase 2 es evaluar la seguridad, tolerabilidad, farmacométrica y eficacia de DNTH103 en participantes con miastenia grave generalizada (MGg).

Descripción detallada

El estudio incluye los siguientes períodos: * Selección (hasta 10 semanas) * Período de tratamiento aleatorizado, ciego y controlado (RCT) (13 semanas) * Período de extensión abierta (OLE) (opcional) para participantes elegibles (52 semanas) * Seguimiento de seguridad (40 semanas)

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Must have given written informed consent before any study-related activities are carried out.
Adult males and females, 18 to 75 years of age (inclusive) at Screening.
Weight range between 40-120 kg at Screening.
Diagnosis of gMG by the following tests:
Acetylcholine receptor antibody (AChR Ab) positive, and
One of the following:
i. History of abnormal neuromuscular transmission test; ii. History of positive anticholinesterase test; iii. Clinical response to acetylcholinesterase inhibitors.
Myasthenia Gravis Foundation of America (MGFA) Class II-Iva
Myasthenia Gravis Activities of Daily Living (MG-ADL) score of 6 or more
Vaccination against N. meningitidis with the quadrivalent meningococcal vaccine, and where available, meningococcal serotype B vaccine within 3 years prior to, or at the time of, initiating study drug.
Female participants must:
Be of non-childbearing potential, or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
Male participants must be surgically sterile for at least 90 days prior to screening or agree not to donate sperm

Criterios de exclusión

History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant
Prior history (at any time) of N. meningitidis infection.
Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies during Screening.
Any thymic surgery/biopsy within 1 year of Screening.
Any known or untreated thymoma.
Any history of thymic carcinoma or thymic malignancy.
Concurrent or previous use of the following medication within the time periods specified below.
Rituximab within 6 months (180 days) prior to randomization (Day 1);
Intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) within 4 weeks (28 days) prior to randomization (Day 1).
Participation in another clinical study of an investigational drug within 90 days or 5 half-lives of the investigational agent.

Intervenciones

drug

DNTH103

Day 1: IV loading dose Week 1 to Week 11: DNTH103 administered SC every 2 weeks

drug

Placebo

Day 1: IV infusion of placebo Week 1 to Week 11: placebo administered SC every 2 weeks

Ubicaciones

Clinical Study Site

San Miguel de Tucumán, Tucumán Province, Argentina

Clinical Study Site

Buenos Aires, Argentina

Clinical Study Site

Buenos Aires, Argentina

Clinical Study Site

Buenos Aires, Argentina

Clinical Study Site

Córdoba, Argentina

Clinical Study Site

Rosario, Argentina

Patrocinadores

PrincipalDianthus Therapeutics

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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