Moderate-to-severe asthma Respiratory
Conditions
Interventions
Participants will be randomized at baseline in a 1:1 ratio, in addition to standard of care therapy, to receive:
1. Depemokimab 100 mg dose administered as a single subcutaneous injection
2. Matching
Sponsors
King's College London
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Ability to provide written informed consent 2. Adults (=18 years at the time of randomisation) 3. Physician-diagnosed asthma with duration of =12 months (based on the BTS/NICE 2024 Guidelines) at the time of randomisation) 4. Treatment with medium or high-dose ICS/LABA therapy (MART is permitted) 5. Documented history of =1 asthma exacerbation requiring the use of systemic corticosteroids (oral or parenteral) during each of the previous 2 autumn/winter seasons (i.e. autumn/winter 2023-24 and 2024-25) or 1 asthma-related hospitalisation in the previous autumn/winter (2024-25). The autumn and winter seasons extend from 15th September to 15th March. 6. The most recent exacerbation must have been whilst the patient was prescribed medium or high dose ICS/LABA 7. Post-bronchodilator FEV1 =60% predicted at randomisation
Exclusion criteria
Exclusion criteria: 1. Known history of systemic hypersensitivity or anaphylaxis to any biologic therapy 2. Regular use of immunosuppressive medication (including but not limited to maintenance daily prednisolone, hydrocortisone, azathioprine, or weekly methotrexate) 3. Receipt of any licensed biologic drug (eg, omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab, tezepelumab, or other monoclonal antibody) or any investigational biologic for asthma within 24 months prior to randomization 4. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial 5. Any unstable or significant other medical condition which, in the opinion of the Investigator, may either put the participant at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma exacerbations – annualised rate (AER) – measured at week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Patient reported asthma control measured using Asthma Control Questionnaire (ACQ-5) at week 26 2. Asthma-related emergency department visits and/or hospitalisations measured at week 26 3. Forced expiratory volume (FEV1) (severity and reversibility of airflow obstruction) – post bronchodilator – measured at week 26 4. Patient-reported quality of life related to asthma measured using the Asthma Quality OF Life Questionnaire (AQLQ (S)=12) at week 26 5. Asthma exacerbations in participants with blood eosinophil count =300 cells/µL at randomisation – annualised rate (AER) – measured at week 26 6. Asthma exacerbations in participants with FeNO =50 ppb at randomisation – annualised rate (AER) – measured at week 26 | — |
Countries
United Kingdom
Outcome results
None listed