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Rademikibart for Acute Asthma Exacerbations

This study is testing a new treatment called rademikibart for people experiencing an acute asthma exacerbation (a sudden worsening of asthma symptoms). You would receive either rademikibart or a placebo (an inactive substance) along with your usual asthma care. The main goal is to see if rademikibart can reduce the rate of treatment failure within 28 days after starting the study. To join, you need to be between 12 and 75 years old, have asthma diagnosed for at least 12 months, and be on certain asthma controller medications. You must also have had at least one asthma attack requiring steroid treatment. The current status of this study is unclear.

Study design
This is a Phase 2, randomized, double-blind, placebo-controlled study involving approximately 160 participants. It compares rademikibart plus standard therapy to standard therapy alone (plus placebo).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 28 days after randomization to assess treatment failure.

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NCT06940141

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

Active, Not Recruiting
PHASE2Ages 12–75InterventionalTreatment
Connect Biopharm LLC
~160 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Rademikibart in prefilled syringeMatching placebo in prefilled syringe

At a glance

Recruiting sites
0 of 58 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment failure rate within 28 days after randomization
Measured over 28 days

Conditions

Asthma Acute

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Where it's being run

58 sites across 25 states
Georgia8
Buenos Aires6
Serbia6
Florida5
United Kingdom5
Texas3
New South Wales3
California2

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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 systemic corticosteroids (ie, oral or by injection) 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.

What this trial measures

  • Treatment failure rate within 28 days after randomization28 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.