At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 264 enrolled
Drug / intervention
Depemokimab (GSK3511294) +1 morebiological
Likely dose
Depemokimab 100 mg SCAI-extracted
Key inclusion· 6
- ✓Age ≥18 years at informed consent
- ✓Endoscopic bilateral nasal polyp score ≥5/8 (minimum 2 in each cavity)
- ✓Prior nasal polyp surgery, or ≥3 consecutive days of systemic corticosteroids in past 2 years for NP, or medically unsuitable/intolerant to systemic corticosteroids
- ✓Daily intranasal corticosteroid therapy for ≥8 weeks prior to screening (except Japan participants)
Key exclusion· 20
- ✕Cystic fibrosis
- ✕Antrochoanal polyps or benign/malignant nasal cavity tumor
- ✕Fungal rhinosinusitis
- ✕Severe nasal septal deviation preventing bilateral nasal polyp assessment
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomised, Double-blind, Parallel Group Phase III Study to Assess the Efficacy and Safety of 100 mg SC Depemokimab in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) - ANCHOR-2 (depemokimAb iN CHrOnic Rhinosinusitis)
In Brief
A Phase 3 clinical trial evaluating Depemokimab (GSK3511294) and Placebo for Nasal Polyps. Completed, enrolled 264 participants across 84 sites in 9 countries.
Detailed Summary
This study will evaluate the efficacy and safety of depemokimab (GSK3511294) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNasal Polyps
CountriesChina, Italy, Japan, Poland, Romania, Spain, Sweden, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedMar 2022
Enrollment StartApr 2022
Primary CompletionJul 2024
Study CompletionAug 2024
TodayJul 2026
First PostedMar 16, 2022
Enrollment StartApr 18, 2022
Primary CompletionJul 12, 2024
Study CompletionAug 6, 2024
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.3 years ago
Interventions
Depemokimab (GSK3511294)biological
Depemokimab (GSK3511294) was administered using a pre-filled syringe.
Placebodrug
Placebo was administered as normal saline using a pre-filled syringe.