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

ConditionNasal Polyps
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlaxoSmithKline

About this trial

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).

Eligibility criteria

Qualifiers

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 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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Depemokimab

Treatment groups

28 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators