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 (based on the GINA 2024 Guidelines).
Currently receiving treatment with low, medium, to high dose ICS (equivalent ICS doses as per GINA 2024 Guidelines) in combination with at least 1 additional asthma controller medication for at least 60 days prior to the Screening.
Must have experienced at least 1 asthma exacerbation requiring the use of systemic corticosteroids (oral or parenteral) within the previous 12 months prior to Screening.
For participants who consent/assent to participate in the trial while in a stable condition, must have a documented historical peripheral blood eosinophil count of ≥250 cells/μL within 12 months prior to Screening.
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 prior to receiving IP.

Exclusion criteria

Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to randomization, whichever is longer.
Unstable ischemic heart disease, cardiomyopathy, heart failure (New York Heart Association Class III or IV), 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 (including HIV-1 or HIV-2). Known medical history of hepatitis B or C.
History of alcohol abuse and/or drug abuse within 12 months prior to Screening.
History of cancer except basal cell carcinoma or in situ carcinoma of the cervix treated with apparent success with curative therapy >1 year prior to entry or other malignancies treated with apparent success with curative therapy >5 years prior to entry.
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 (eg, suplatast tosilate) 30 days or 5 half-lives prior to randomization, whichever is longer.
Receipt of any marketed biologic drug or any investigational biologic for asthma 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.
Participants that have been treated with bronchial thermoplasty in the last 12 months prior to Visit 1b.
Treatment with OCS and/or hospitalization for an exacerbation of asthma less than 4 weeks prior to randomization.
Receipt of any investigational nonbiologic drug within 30 days or 5 half-lives prior to randomization, whichever is longer.

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