Rademikibart IV for Acute Asthma and COPD Exacerbation
Purpose
A Phase 2, open-label, single-arm trial to evaluate IV rademikibart as an add-on treatment for acute exacerbation in participants with asthma or COPD with type 2 inflammation
Conditions
- Asthma Acute
- COPD Exacerbation Acute
Eligibility
- Eligible Ages
- Between 18 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Asthma cohort - Body weight of ≥40 kg and BMI ≤45 kg/m2 at SV1a. - Physician-diagnosed asthma - 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. - Participants in a stable condition, must have a 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
- Asthma cohort - Regular use of immunosuppressive medication. - Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension. - Current or former smoker, with a smoking history of ≥5 pack-years if <30 years old or ≥10 pack-years if ≥30 years old - 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 or other malignancies treated with apparent success with curative therapy. - Female participant who is pregnant, lactating or breast-feeding. - Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines. - 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 receipt of any investigational nonbiologic drug. - A recent chest X-ray or computed tomography with findings that are inconsistent for an asthmatic population. Inclusion Criteria - COPD cohort - Body weight of ≥45 kg and BMI ≤45 kg/m2 - Physician-diagnosed COPD - Must have experienced at least 1 COPD exacerbation requiring the use of systemic corticosteroids. - Participants in a stable condition must have a historical peripheral blood eosinophil count of ≥250 cells/μL and/or FeNO ≥ 25 ppb. - Current or former smoker with a history of smoking of ≥10 pack-years. - Current acute COPD exacerbation requiring an urgent healthcare visit for treatment. - Peripheral blood eosinophil count of ≥300 cells/μL as part of the assessment of the index acute COPD exacerbation. - Requires systemic corticosteroids as standard of care treatment in the urgent healthcare setting for the current acute COPD exacerbation. Exclusion Criteria - COPD cohort - Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to approximately 12 weeks or 5 half-lives, whichever is longer. - Current diagnosis or a history of asthma, according to the Global Initiative for Asthma; or participants with a current diagnosis or history of Asthma COPD Overlap Syndrome. - Other respiratory disorders that might compromise the safety of the participant or affect the interpretation of the results. - Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension. Cardiac arrhythmias including paroxysmal atrial fibrillation. - Transient ischemic attack or stroke <6 months from Screening Visit; hospitalization for any cardiovascular or cerebrovascular event <6 months from Screening Visit. - 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. - Chronic treatment with long-term oxygen therapy or nocturnal oxygen therapy required for >15 hours a day. - Participants on long-term macrolide. - Current acute COPD exacerbation for which SoC was started >48 hours prior to Screening. - A recent chest X-ray or computed tomography scan reveals evidence of clinically significant abnormalities or pulmonary infection. - Female participant who is pregnant, lactating or breast-feeding. - Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to SV1b, whichever is longer. - Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives, whichever is longer. - Live, attenuated vaccinations within 4 weeks prior to screening or planned live, attenuated vaccinations during the trial. 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Rademikibart |
|
Recruiting Locations
Pharmax Research of South Florida, Inc.
Miami, Florida 33175
Miami, Florida 33175
More Details
- Status
- Recruiting
- Sponsor
- Connect Biopharm LLC
Detailed Description
A phase 2, open-label, single-arm trial to assess the efficacy of a single 300 mg dose of rademikibart administered as a 2-minute IV infusion (IV push) on lung function in participants with asthma or COPD with type 2 inflammation who require an urgent healthcare visit for the treatment of acute exacerbation.