Rademikibart IV for Acute Asthma and COPD Exacerbation

Ki vehet részt

• 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
• 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

Ki nem vehet részt

• Regular use of immunosuppressive medication
• Recent receipt of any marketed nonbiologic drug that modulates type 2 cytokines
• Participants that have been recently treated with bronchial thermoplasty
• Recent receipt of any investigational nonbiologic drug
• Regular use of immunosuppressive medication 12 weeks or 5 half-lives prior to approximately 12 weeks or 5 half-lives, whichever is longer
• Chronic treatment with long-term oxygen therapy or nocturnal oxygen therapy required for >15 hours a day
• Current acute COPD exacerbation for which SoC was started >48 hours prior to Screening
• Receipt of any marketed nonbiologic drug that modulates type 2 cytokines 30 days or 5 half-lives prior to SV1b, 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
• Unstable ischemic heart disease, cardiomyopathy, heart failure, uncontrolled hypertension
• 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
• Recent receipt of any marketed biologic drug or any investigational biologic for asthma or other diseases
• 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
• A recent chest X-ray or computed tomography scan reveals evidence of clinically significant abnormalities or pulmonary infection
• Receipt of any marketed or any investigational biologic for COPD or other diseases within 16 weeks or 5 half-lives, whichever is longer
• Current or former smoker, with a smoking history of ≥5 pack-years if <30 years old or ≥10 pack-years if ≥30 years old
• Female participant who is pregnant, lactating or breast-feeding
• Recent live, attenuated vaccinations or planned live, attenuated vaccinations during the trial
• A recent chest X-ray or computed tomography with findings that are inconsistent for an asthmatic population
• Participants on long-term macrolide
• Female participant who is pregnant, lactating or breast-feeding