Study Summary
This trial will study whether a new drug, called depemokimab, is effective and safe in people with CRSwNP.
Eligible Conditions
- Nasal Polyps
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 8 Secondary · Reporting Duration: Baseline and from Week 49 to Week 52
Week 26
Change from Baseline in total endoscopic NP score at Week 26 (scores on a scale)
Week 52
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score (scores on a scale)
Change from Baseline in Lund Mackay (LMK) computed tomography (CT) score (scores on a scale)
Nose
Change from Baseline in total endoscopic nasal polyps (NP) score at Week 52 (scores on a scale)
Week 24
Change from Baseline in mean nasal obstruction score using VRS from Weeks 21 to 24 (scores on a scale)
Week 52
Change from Baseline in mean nasal obstruction score using verbal response scale (VRS) from Weeks 49 to 52 (scores on a scale)
Change from Baseline in mean symptom score for loss of smell using VRS (scores on a scale)
Rhinorrhea
Change from Baseline in mean symptom score for rhinorrhoea (runny nose) using VRS (scores on a scale)
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Participants receiving depemokimab (GSK3511294)
1 of 2
Participants receiving Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
250 Total Participants · 2 Treatment Groups
Primary Treatment: Depemokimab (GSK3511294) · Has Placebo Group · Phase 3
Participants receiving depemokimab (GSK3511294)
Biological
Experimental Group · 1 Intervention: Depemokimab (GSK3511294) · Intervention Types: BiologicalParticipants receiving Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and from week 49 to week 52
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,648 Previous Clinical Trials
7,945,702 Total Patients Enrolled
6 Trials studying Nasal Polyps
967 Patients Enrolled for Nasal Polyps
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,560 Previous Clinical Trials
6,129,188 Total Patients Enrolled
5 Trials studying Nasal Polyps
960 Patients Enrolled for Nasal Polyps
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are 18 years or older at the time of signing the informed consent.
Endoscopy revealed a joint score of at least 5 out of 8 (with no less than 2 in each nostril) as judged by the investigator.
You have either undergone nasal surgery for the removal of nasal polyps, used systemic corticosteroids in the past two years to treat NP, or are medically unsuitable for/intolerant to using systemic corticosteroids.
All participants, barring those from Japan, must have been using daily intranasal corticosteroids (including liquid steroid wash/douching) for a minimum of 8 weeks before screening.
Participants exhibiting pronounced NP symptoms, such as nasal congestion/blockage/obstruction with moderate or severe intensity and impaired olfactory senses or rhinorrhea (runny nose) appraised by the researcher.
You have experienced two or more symptoms of chronic rhinosinusitis over the course of 12 weeks preceding Visit 1, including at least one out of nasal blockage/obstruction/congestion and nasal discharge (anterior/posterior nasal drip), as well as facial pain/pressure and/or reduction or loss of smell.
Both male and female participants who meet the eligibility criteria are welcome.
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Conditions
Cancer Related
Treatments