Status:
RECRUITING
Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
Lead Sponsor:
Connect Biopharm LLC
Conditions:
Asthma Acute
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
Brief Summary
This is a Phase 2, randomized, multicenter study in adult and adolescent participants with asthma and type 2 inflammation
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06940141
Start Date
August 8 2025
End Date
May 1 2026
Last Update
January 9 2026
Active Locations (36)
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1
Amicis Research Center
Valencia, California, United States, 91355
2
Synergy Healthcare
Bradenton, Florida, United States, 34209
3
Pharmax Research of South Florida, Inc.
Miami, Florida, United States, 33175
4
Columbus Clinical Services, LLC
Miami, Florida, United States, 33215