RecruitingPhase 2NCT06940141
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
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
Sponsor
Connect Biopharm LLC
Enrollment
160 participants
Start Date
Aug 8, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
Eligibility
Min Age: 12 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria16
- 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.
Interventions
COMBINATION_PRODUCTRademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
DRUGMatching placebo in prefilled syringe
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Locations(46)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06940141
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