- Depemokimab Asthma Imaging and Bronchoscopy Sub-Study — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT06979323.
- What is being tested: Depemokimab, a monoclonal antibody, is being evaluated for its effects on airway structure and function in asthma patients using imaging and bronchoscopy techniques as part of a mechanistic sub-study.
- Patient eligibility overview: The study recruits asthma patients from the main depemokimab trial; specific eligibility criteria typically include confirmed asthma diagnosis, adequate lung function for bronchoscopy, and willingness to undergo invasive airway sampling procedures.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably.\xa0The purpose of this study is to assess how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic participants with type 2 inflammation, characterized by an eosinophilic phenotype.
- : * Documented clinical diagnosis of asthma for greater than or equal to (>=) 2 years as per the National Heart, Lung, and Blood Institute guidelines (NHLBI, 2020) or GINA guidelines (GINA, 2024), or joint guidance from the British Thoracic Society, National Institute for Health and Care Excellence, and Scottish Intercollegiate Guidelines Network [NICE, 2024] along with the following: an eosinophilic phenotype as evidenced by a blood eosinophil count of >=300 cells/microliters (mcL) at screening or a documented history of blood eosinophil count >=300 cells/mcL within 3 months prior to screening; Exhaled nitric oxide (FeNO) measure of >=25 parts per billion (ppb) recorded at screening; and a previously confirmed history of >= 2 exacerbations requiring treatment with systemic corticosteroid (SCS; intramuscular [IM], intravenous [IV], or oral), in the 12 months prior to screening, despite the use of medium to high dose Inhaled corticosteroids (ICS) * Uncontrolled asthma indicated by Astha Control Questionnaire-5 (ACQ-5) greater than (>) 1.5 recorded at screening * Persistent airflow obstruction as indicated by pre-bronchodilator Forced Expiration Volume in 1 second (FEV1) less than (=20 pack years (number of pack years = [number of cigarettes per day/20] x number of years smoked) and vapers * Participants…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.