Status:
COMPLETED
Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Nasal Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
Eligibility Criteria
Inclusion
- Participants with 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 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.
- Participants (except for those in Japan) must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least 8 weeks prior to screening.
- Participants presenting with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhea (runny nose) based on clinical assessment by the investigator.
- Presence of symptoms of chronic rhinosinusitis as described by at least 2 different symptoms for at least 12 weeks prior to Visit 1, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), plus facial pain/pressure and/or reduction or loss of smell.
- Male or eligible female participants
Exclusion
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 6 2024
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT05281523
Start Date
April 18 2022
End Date
August 6 2024
Last Update
September 9 2025
Active Locations (84)
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1
GSK Investigational Site
Tucson, Arizona, United States, 85724
2
GSK Investigational Site
Roseville, California, United States, 95661
3
GSK Investigational Site
New Haven, Connecticut, United States, 06520
4
GSK Investigational Site
Hialeah, Florida, United States, 33012