Ensayo Clínico de Fase 2, Multicéntrico, Aleatorizado, Doble Ciego, de Grupos Paralelos, Controlado con Placebo para Evaluar la Eficacia y Seguridad de Rademikibart como Tratamiento Complementario para la Exacerbación Aguda en Participantes con Enfermedad Pulmonar Obstructiva Crónica e Inflamación de Tipo 2

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06940154Tipo: INTERVENTIONALInicio: 12 de ago de 2025Fin estimado: 1 de may de 2026

Resumen

Este es un estudio de Fase 2, multicéntrico, en participantes adultos con una exacerbación aguda de EPOC e inflamación de tipo 2.

Descripción detallada

Este es un ensayo clínico de Fase 2, aleatorizado, doble ciego, controlado con placebo, de grupos paralelos e intervención, en participantes con una exacerbación aguda de EPOC con inflamación de tipo 2 en el ámbito de atención médica urgente, para comparar rademikibart más terapia estándar con terapia estándar (más placebo).

Elegibilidad

Edad mínima: 40 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Physician-diagnosed COPD with duration of ≥12 months.
Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids.
Participants in a stable condition must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
Current or former smoker with a history of smoking of ≥10 pack-years.
Current acute COPD exacerbation requiring an urgent healthcare visit for treatment.
Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation.
Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation.

Criterios de exclusión

Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome.
Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results.
Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation.
Transient ischemic attack or stroke \<6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event \<6 months from Screening Visit.
Known or suspected history of immunosuppression.
History of known immunodeficiency disorder or hepatitis B or C.
History of alcohol abuse and/or drug abuse.
Recent history of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success.
Chronic treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for \>15 hours a day.
Participants on long-term macrolide.
Current acute COPD exacerbation for which SoC was started \>48 hours prior to Screening.
A recent chest X-ray or computed tomography (CT) scan at Screening reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD, or a clinically significant pulmonary infection identified by chest X-ray (CT scan).
Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β-hCG test prior to randomization.
Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to randomization, whichever is longer.
Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives prior to randomization, whichever is longer.
Live, attenuated vaccinations within 4 weeks prior to randomization or planned live, attenuated vaccinations during the trial.
Treatment with oral corticosteroids and/or hospitalization for an exacerbation of COPD completed less than 4 weeks prior to randomization.

Intervenciones

combination_product

Rademikibart in prefilled syringe

Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.

drug

Matching placebo in prefilled syringe

Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.

Ubicaciones

CEMER - Centro Medico de Enfermedades Respiratorias

Florida, Buenos Aires, Argentina

Radha Adivikolanu

NOT_YET_RECRUITING

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Radha Adivikolanu

NOT_YET_RECRUITING

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Radha Adivikolanu

NOT_YET_RECRUITING

Investigaciones en Patologias

San Miguel de Tucumán, Tucumán Province, Argentina

Radha Adivikolanu

NOT_YET_RECRUITING

Patrocinadores

PrincipalConnect Biopharm LLC

Contactos

Radha Adivikolanu

CONTACT

clinical207@connectpharm.com 213-522-7990

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.

Ensayo Clínico de Fase 2, Multicéntrico, Aleatorizado, Do... | EligiMed