Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)

Connect Biopharm LLC

Status and phase

Enrolling

Phase 2

Conditions

Asthma Acute

Treatments

Combination Product: Rademikibart in prefilled syringe

Drug: Matching placebo in prefilled syringe

Study type

Interventional

Funder types

Industry

Identifiers

NCT06940141

CBP-201-206

Details and patient eligibility

About

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

Full description

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.

Enrollment

160 estimated patients

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

The above inclusion and exclusion criteria are not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.