A Phase 2, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Rademikibart as an Add-on Treatment for Acute Exacerbation in Adult and Adolescent Participants With Asthma and Type 2 Inflammation

ReclutandoFase 2ClinicalTrials.gov

ID: NCT06940141Tipo: INTERVENTIONALInicio: 8 de ago de 2025Fin estimado: 1 de may de 2026

Traducción no disponible, mostrando original

Resumen

This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation

Descripción detallada

This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, interventional trial in participants with an acute asthma exacerbation with type 2 inflammation to compare rademikibart plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

Physician-diagnosed asthma with duration of ≥12 months.
Currently receiving treatment with low, medium, to high dose ICS in combination with at least 1 additional asthma controller medication.
Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids.
For participants in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb.
Current acute asthma exacerbation requiring an urgent healthcare visit for treatment.
Peripheral blood eosinophil count of ≥300 cells/µL as part of the assessment of an index acute asthma exacerbation.
Requires systemic corticosteroid as SoC in the urgent healthcare setting to treat the current acute asthma exacerbation.
FEV1 ≥30% predicted.

Criterios de exclusión

Regular use of immunosuppressive medication.
Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension.
Current or former smoker, has a smoking history including: If \<30 years old: Smoked for ≥5 pack-years; If ≥30 years old: Smoked for ≥10 pack-years
COPD and other clinically significant pulmonary disease other than asthma.
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 with curative therapy or other malignancies treated with apparent success with curative therapy.
Female participant who is pregnant, lactating or breast-feeding, or has a positive urinary β hCG test prior to randomization.
Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines (eg, suplatast tosilate).
Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases.
Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial.
Participants that have been recently treated with bronchial thermoplasty.
Recent treatment with OCS and/or hospitalization for an exacerbation of asthma.
Recent receipt of any investigational nonbiologic drug.
A recent chest X-ray or computed tomography (CT) with findings that are inconsistent for an asthmatic population.

Intervenciones

combination_product

Rademikibart in prefilled syringe

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

drug

Matching placebo in prefilled syringe

Contactos

Radha Adivikolanu

CONTACT

clinical206@connectpharm.com 213-522-7990

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