About this trial
An open-label study will evaluate effects of Depemokimab in the treatment of severe eosinophilic asthma in patients with allergic bronchopulmonary aspergillosis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female and Male patients aged 18-75 years
Diagnosis of Allergic Bronchopulmonary Aspergillosis (according to the ISHAM Working Group Diagnostic Criteria)
Severe asthma requiring treatment with high dose ICS plus a long acting beta-agonist (LABA) or long-acting muscarinic antagonists (LAMA)), or maintenance OCS (daily or every other day OCS requirement in order to maintain asthma control)
Disqualifiers
History of allergy or hypersensitivity reaction to Depemokimab or any of its components.
Currently pregnant, breastfeeding, or lactating women.
Concurrent enrollment in another interventional or post-authorization safety study, unless it is observational.
Trial design
Single group
Treatments tested in this trial
Depemokimab
Drug100 mg (1mL) Subcutaneous Solution
Treatment groups
Trial outcomes
Primary outcomes
Number of steroid requiring exacerbations
Number of asthma exacerbations requiring the initiation of (or temporary increase in) systemic corticosteroids in severe eosinophilic asthma complicated by ABPA
Secondary outcomes
Patient-Reported Quality of Life as assessed by Saint George Respiratory Questionnaire
The change from baseline score in Saint George Respiratory Questionnaire. The Saint George Respiratory Questionnaire (SGRQ) total score ranges from 0 to 100. Higher scores indicate a worse outcome (greater health impairment/poorer quality of life)
Asthma Control as assessed by Asthma Control Questionnaire 6
The change from baseline score in Asthma Control Questionnaire 6. ACQ-6 scores range from 0 to 6, where higher scores represent poorer asthma control. A score ≤0.75 indicates well-controlled asthma, while a score ≥1.5 indicates uncontrolled asthma.
Lung Function (FEV1)
The FEV1 change from baseline to End of Treatment
Sponsors and contacts
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