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

Phase 2

Recruiting

• Conditions: Asthma Acute
• Interventions: Combination Product: Rademikibart in prefilled syringe; Drug: Matching placebo in prefilled syringe

• Registration Number: NCT06940141
• Lead Sponsor: Connect Biopharm LLC

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 plus standard therapy to standard therapy alone (plus placebo), targeting an acute asthma exacerbation in the urgent healthcare setting.

Study Timeline

• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-15
• Study First Posted: 2025-04-23
• Study Start: 2025-08-08
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-28
• Last Update Posted: 2025-10-30
• Primary Completion: 2026-04
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rademikibart	Rademikibart in prefilled syringe	-
Placebo	Matching placebo in prefilled syringe	-

Primary Outcome Measures

Name	Time	Method
Treatment failure rate within 28 days after randomization	28 days	Treatment failure is defined as death due to any cause, (re)admission to a hospital for asthma, ED (re)visit or unscheduled medical visit for worsening of asthma symptoms, or the necessity to intensify pharmacologic treatment (including second course of systemic steroids for asthma exacerbation) within 28 days after randomization.

Secondary Outcome Measures

Name	Time	Method
Rate of new asthma exacerbations in the 28 days after randomization	28 days
Time to the first new asthma exacerbation in the 28 days after randomization	28 days
Mean change from baseline (CFB) in nocturnal awakenings (e-diary)	Week 1, Week 2, and Week 4
Absolute CFB in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)	Day 3, Week 1, and Week 4
Mean change from baseline (CFB) in morning/evening asthma symptom score	Week 1, Week 2, and Week 4
Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported	56 days
Incidence of unanticipated adverse device effects (UADEs)	56 days
Incidence of injection site reactions	56 days

Trial Locations

Locations (19)

Amicis Research Center; 🇺🇸 Valencia, California, United States

Primeway Clinical Research Group; 🇺🇸 Fayetteville, Georgia, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States

Allergy & Asthma Specialists, P.S.C.; 🇺🇸 Owensboro, Kentucky, United States

Premier Pulmonary Critical Care and Sleep Medicine; 🇺🇸 Denison, Texas, United States

St. Vincent's Hospital Sydney; 🇦🇺 Darlinghurst, New South Wales, Australia

"NCTLD National Center for Tuberculosis and Lung Disease" JSC; 🇬🇪 Tbilisi, Georgia

LLC "Israel-Georgian Medical Research Clinic Healthycore"; 🇬🇪 Tbilisi, Georgia

Raymann, LLC; 🇬🇪 Tbilisi, Georgia

Bradford Teaching Hospitals NHS Foundation Trust; 🇬🇧 Bradford, United Kingdom

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