Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
Phase 2
Recruiting
- Conditions
- Asthma Acute
- Interventions
- Combination Product: Rademikibart in prefilled syringeDrug: 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
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.
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 morning/evening asthma symptom score Week 1, Week 2, and Week 4 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 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 (1)
Synergy Healthcare
🇺🇸Bradenton, Florida, United States