Phase 3
N=264
Efficacy and Safety of Depemokimab (GSK3511294) in Participants With Chronic Rhinosinusitis With Nasal Polyps (ANCHOR-2)
Nasal Polyps
Bottom Line
View on ClinicalTrials.gov: NCT05281523 ↗Enrolled (actual)
264
Serious AEs
6.2%
Results posted
Sep 2025
Primary outcome: Primary: Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read) — -0.5; 0.1 Scores on scale — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Depemokimab (GSK3511294) (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Endoscopic Nasal Polyps (NP) Score at Week 52 (Centrally Read) |
-0.5; 0.1 | 0.004 sig |
| PRIMARY Change From Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale From Weeks 49 Through to Week 52 |
-0.77; -0.53 | 0.025 sig |
| SECONDARY Change From Baseline in Mean Symptom Score for Rhinorrhea (Runny Nose) Using Verbal Response Scale From Week 49 Through to Week 52 |
-0.72; -0.54 | 0.125 |
| SECONDARY Change From Baseline in Mean Symptom Score for Loss of Smell From Week 49 Through to Week 52 |
-0.56; -0.30 | 0.007 sig |
| SECONDARY Change From Baseline in Lund Mackay (LMK) Computed Tomography (CT) Score at Week 52 |
-3.5; -0.3 | <0.001 sig |
| SECONDARY Change From Baseline in Sino-nasal Outcome Test (SNOT)-22 Total Score at Week 52 |
-15.9; -6.0 | 0.015 sig |
| SECONDARY Change From Baseline in Mean Nasal Obstruction Score From Week 21 Through to Week 24 |
-0.78; -0.54 | 0.016 sig |
| SECONDARY Change From Baseline in Total Endoscopic Nasal Polyps Score at Week 26 |
-0.5; -0.1 | 0.066 |
| SECONDARY Percentage of Participants Requiring First Nasal Surgery (Actual or Entry on Waiting List) or Disease-Modulating Medication for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Up to Week 52 |
15.0; 21.9 | 0.128 |
| SECONDARY Percentage of Participants Requiring First Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP up to Week 52 |
12.2; 16.7 | 0.146 |
| SECONDARY Percentage of Participants Requiring at Least One Course of Systemic Corticosteroids or Disease-Modulating Medication for CRSwNP or Nasal Surgery (Actual) During the Week 52 Treatment Period |
26; 36 | 0.006 sig |
| SECONDARY Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Week 52 |
-0.75; 0.00 | 0.004 sig |
Summary
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
Eligibility Criteria
Inclusion Criteria
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 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 Criteria
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.
- Participants who have undergone any intranasal and/or sinus surgery (for example polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to Visit 1; nasal biopsy prior to Visit 1 for diagnostic purposes only is excepted.
- Participants where NP surgery is contraindicated in the opinion of the Investigator.
- Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) eosinophilic granulomatosis with polyangiitis (EGPA) (formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis.
- Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1.
- A known immunodeficiency (e.g. human immunodeficiency virus (HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma.
- A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
- Liver Disease: Alanine aminotransferase (ALT) >2 times upper limit normal (ULN); Total bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<]35 percent [%]); Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice.
- Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment.
- Participants with current diagnosis of vascul
Data sourced from ClinicalTrials.gov (NCT05281523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.