Asthma Acute
Conditions
Keywords
Acute exacerbation, Asthma, Asthma exacerbation, CBP-201, Rademikibart, Connect Biopharma
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.
Interventions
COMBINATION_PRODUCTRademikibart in prefilled syringe
Participants receive 600 mg (4mL) of rademikibart administered subcutaneously.
Participants receive 4mL of placebo matched to rademikibart administered subcutaneously.
Sponsors
Connect Biopharm LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
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 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. The above inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Absolute change from baseline (CFB) in post-bronchodilator (BD) forced expiratory volume in 1 second (FEV1) at Week 1 | Week 1 |
| 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 CFB in morning/evening asthma symptom score | Week 1, Week 2, and Week 4 |
| Mean CFB in nocturnal awakenings (e-diary) | Week 1, Week 2, and Week 4 |
| Absolute CFB in post-BD FEV1 | Day 3 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 |
Countries
Argentina, Australia, Georgia, Serbia, United Kingdom, United States
Outcome results
None listed