Last updated: 10/06/2025 09:50:11
Indirect Treatment Comparison (ITC) of Depemokimab in Chronic rhinosinusitis with nasal polyps (CRSwNP)
GSK study ID
300722
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: Indirect Treatment Comparison (ITC) of Depemokinab in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Trial description: Depemokimab, a long-acting anti-interleukin (IL)-5 monoclonal antibody, is currently being assessed for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), a condition causing nasal blockage and inflammation. In ANCHOR 1 and 2, randomized, placebo-controlled, double-blind, parallel group design clinical trials, Depemokimab demonstrated statistically significant and clinically meaningful efficacy compared to placebo. However, there is a need to understand how Depemokimab also compares to other biologic treatments for CRSwNP. The objective of this study is to reduce uncertainty in the relative clinical effect and safety of Depemokimab versus relevant comparator biologics in participants with CRSwNP. Anchored indirect treatment comparisons will be employed that collectively combine data across randomized clinical trials of Depemokimab and other relevant biologic treatments for CRSwNP.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from Baseline in Total Endoscopic Nasal Polyp (NP) Score at Week 52
Timeframe: From Baseline up to Week 52
Percentage of Participants Achieving greater than or equal to (>=) 1-point Decrease from Baseline in Total Endoscopic NP Score at Week 52
Timeframe: From Baseline up to Week 52
Change from Baseline in Sino-Nasal Outcome Test (SNOT)-22 Total Score at Week 52
Timeframe: From Baseline up to Week 52
Percentage of Participants Achieving >= 8.9-point Decrease from Baseline in SNOT-22 Total Score at Week 52
Timeframe: From Baseline up to Week 52
Secondary outcomes:
Time to First Nasal Surgery for CRSwNP
Timeframe: Up to Week 52
Percentage of Participants Requiring at least 1 Nasal Surgery for CRSwNP
Timeframe: Up to Week 52
Percentage of Participants Requiring at least 1 course of Systemic corticosteroid (SCS) for CRSwNP
Timeframe: Up to Week 52
Interventions:
Not applicable
Enrollment:
20
Primary completion date:
2026-09-03
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Nasal Polyps
Product
Not applicable
Collaborators
Not applicable
Study date(s)
October 2025 to March 2026
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Randomized trials of adults with CRSwNP that were treated with relevant biologics or biosimilars (alone or in combination with other treatments) that are currently approved, recommended or under investigation.
- Randomized trials of populations other than CRSwNP and/or patients who are ineligible for treatment with relevant biologics or biosimilars.
Inclusion and exclusion criteria
Inclusion criteria:
- Randomized trials of adults with CRSwNP that were treated with relevant biologics or biosimilars (alone or in combination with other treatments) that are currently approved, recommended or under investigation.
Exclusion criteria:
- Randomized trials of populations other than CRSwNP and/or patients who are ineligible for treatment with relevant biologics or biosimilars.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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