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

Sponsor
GlaxoSmithKline
Study ID
NCT07701967
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Depemokimab — BIOLOGICAL
    Participants will receive depemokimab.

Study Details

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).

Key Dates

First listed
Jul 14, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Jul 1, 2027
Completion
Jun 16, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Depemokimab + SoC
    Participants will receive depemokimab along with their existing baseline maintenance CRSwNP standard of care (SOC) treatment (excluding INCS).

Primary Outcome Measure

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 [ Time Frame: At Week 52 ]

Central Contacts

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