Clinical trial NCT06940141: Rademikibart Add-on Treatment of an Acute Asthma Exacerbation (Seabreeze STAT Asthma)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Asthma Acute
Keywords: Acute exacerbation
Asthma
Asthma exacerbation
CBP-201
Rademikibart
Connect Biopharma
Lead sponsor: Connect Biopharm LLC
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 160
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment failure rate within 28 days after randomization
timeFrame: 28 days
Secondary outcomes:
measure: Rate of new asthma exacerbations in the 28 days after randomization
timeFrame: 28 days
measure: Time to the first new asthma exacerbation in the 28 days after randomization
timeFrame: 28 days
measure: Mean change from baseline (CFB) in morning/evening asthma symptom score
timeFrame: Week 1, Week 2, and Week 4
measure: Mean change from baseline (CFB) in nocturnal awakenings (e-diary)
timeFrame: Week 1, Week 2, and Week 4
measure: Absolute CFB in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1)
timeFrame: Day 3, Week 1, and Week 4
measure: Incidence of adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESIs), and drug-induced liver injury (DILI) reported
timeFrame: 56 days
measure: Incidence of unanticipated adverse device effects (UADEs)
timeFrame: 56 days
measure: Incidence of injection site reactions
timeFrame: 56 days
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: Synergy Healthcare
state: Florida
Study officials:
References: