Rademikibart given by vein for sudden worsening of asthma or COPD

Trial details

Who runs it

Connect Biopharm LLC

Trial code

NCT07705737

Record updated

4 November 2026

Original description

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 inflammationRead full original descriptionShow less

A Phase 2, Open-Label, Single-Arm Trial to Evaluate IV Rademikibart as an Add-on Treatment for Acute Exacerbation in Participants With Asthma and or COPD With Type 2 Inflammation

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

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT07705737