About this trial
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) without concomitant use of Intranasal corticosteroids (INCS) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
Eligibility criteria
Qualifiers
18 years of age and older inclusive, at the time of signing the informed consent
Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) assessed by the investigator
Participants who have had previous nasal surgery for the removal of nasal polyps, have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of nasal polyps, or are medically unsuitable or intolerant to systemic corticosteroid
Participants presenting with severe nasal polyp symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhoea (runny nose) based on clinical assessment by the investigator
Disqualifiers
As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study
Cystic fibrosis
Antrochoanal polyps
Nasal cavity tumor (malignant or benign)
Trial design
Treatments tested in this trial
- Depemokimab