Clinical Trial TitleA randomized, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) – ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)
National Clinical Trial Number:NCT05274750
Clinical Trial Protocol Description:
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with CRSwNP.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have an 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.
- Have had at least one of the following at Visit 1: Previous nasal surgery for the removal of NP; have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of NP; medically unsuitable or intolerant to systemic corticosteroid.
- Have severe NP symptoms defined as symptoms of nasal congestion/blockade/
obstruction with moderate or severe severity (VRS score of 2 or 3) and loss of smell or rhinorrhea (runny nose).
You will be excluded from the study if any of the following criteria apply to you:
- As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study.
- Have cystic fibrosis.
- Have severe nasal septal deviation occluding one nostril preventing full assessment of nasal polyps in both nostrils.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.