Efficacy and Safety of Depemokimab Monotherapy Without Concomitant Use of Intranasal Corticosteroids (INCS) in Japanese Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

NCT07701967 | Not Yet Recruiting Phase 4

• 1 other identifier: 307355
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

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).

Conditions

Nasal Polyps

Keywords

Depemokimab; GSK3511294; Chronic rhinosinusitis with nasal polyps; CRSwNP; Phase IV clinical trial; Japanese participants; Efficacy; Safety; Monotherapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving a One-point or Greater Decrease from Baseline in Total Endoscopic Nasal Polyp (NP) Score Without First Having Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP

  The total endoscopic NP score will evaluate the size and extent of nasal polyps via endoscopy. The assessments will be performed using centrally reviewed video recordings of nasal endoscopy. The right and left nostrils will be scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores will be graded based on NP size and will be recorded as the sum of the right and left nostril scores, ranging from 0 (no polyps) to 8 (large polyps), calculated by summing the scores \[0 to 4\] in each nostril, with higher scores indicating worse status.

  At Week 52

Secondary Outcomes (6)

• Change from Baseline in Total Endoscopic NP Score

  Baseline (Day 1) and Week 52

• Change from Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale (VRS)

  Baseline (Day 1) and from Week 49 through to Week 52

• Change from Baseline in Mean Symptom Score for Rhinorrhoea (Runny Nose) Using VRS

  Baseline (Day 1) and from Week 49 through to Week 52

• Change from Baseline in Mean Symptom Score for Loss of Smell Using VRS

  Baseline (Day 1) and from Week 49 through to Week 52

• Change from baseline in Lund Mackay Computerised Tomography (CT) score

  Baseline (Day 1) and Week 52

Study Arms (1)

Depemokimab + SoC

EXPERIMENTAL

Participants will receive depemokimab along with their existing baseline maintenance CRSwNP standard of care (SOC) treatment (excluding INCS).

Biological: Depemokimab

Interventions

Depemokimab BIOLOGICAL

Participants will receive depemokimab.

Also known as: GSK3511294

Depemokimab + SoC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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), or facial pain/pressure and/or reduction or loss of smell
• Male or eligible female participants

You may not qualify if:

• 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 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): June 16, 2028
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.