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Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

A Randomised, 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)

NCT05274750•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 the 8 weeks immediately 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 Criteria

•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).
•Fungal rhinosinusitis.
•Severe nasal septal deviation occluding one nostril preventing full assessment of nasal polyps in both nostrils
•Participants who had a sino-nasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of nasal polyp score.
•Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening.
•Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis).
•Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of screening.
+14 more criteria

Locations (105)

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Buena Park, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Stanford, California, United States

GSK Investigational Site

Temecula, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

Gainesville, Florida, United States

GSK Investigational Site

Tamarac, Florida, United States

GSK Investigational Site

Tampa, Florida, United States

Key Dates

Start Date

April 22, 2022

Primary Completion Date

July 30, 2024

Completion Date

August 27, 2024

Last Updated

December 3, 2025

Enrollment

276

ACTUAL participants

Conditions

Nasal Polyps

Interventions

Depemokimab (GSK3511294)

BIOLOGICAL

Placebo

DRUG

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study

NCT06914908

Chronic Rhinosinusitis With Nasal Polyps

View study

RECRUITING

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

NCT05246267

Chronic Rhinosinusitis With Nasal Polyps

View study

RECRUITINGNA

Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps

Inclusion Criteria

Exclusion Criteria

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

Real-Time Diagnosis of Eosinophilic Nasal Polyps Using High-Sensitivity Spectroscopy

Complete Remission After Treatment With Biologics for Nasal Polyps

3D Printing to Improve Nasal Irrigation Outcome

Biomarkers of Response to Mepolizumab Treatment in Patients With Nasal Polyps With or Without Bronchial Asthma