Last updated: 10/06/2025 04:50:23
Indirect Treatment Comparison of Depemokimab Compared to Other Respiratory Biologics in Severe Asthma
GSK study ID
212680
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruitment complete
Recruitment complete
Trial overview
Official title: Indirect Treatment Comparison of Depemokimab Compared to Other Respiratory Biologics in Severe Asthma
Trial description: Depemokimab, a long-acting anti-interleukin (IL)-5 monoclonal antibody, is currently being assessed for the treatment of severe asthma with an eosinophilic phenotype despite treatment with standard of care (SoC). SWIFT 1 (206713) and 2 (213744), randomized, placebo-controlled, double-blind, parallel group design clinical trials, both demonstrated statistically significant and clinically meaningful reductions in exacerbations over 52 weeks compared to placebo. However, there is a need to understand how Depemokimab also compares to other biologic treatments for severe asthma. The objective of this study is to reduce uncertainty in the relative clinical effect and safety of Depemokimab versus relevant comparator respiratory biologics in participants with severe asthma. Anchored indirect treatment comparisons will be employed that collectively combine data across randomized clinical trials of Depemokimab (SWIFT 1 and SWIFT 2) and other relevant biologic treatments for severe asthma.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Annualized Exacerbation Rate (AAER) of Clinically Significant Exacerbations
Timeframe: Up to Week 52
Annualized Severe Exacerbation Rate Requiring Hospitalization Visit
Timeframe: Up to Week 52
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1) At Week 52
Timeframe: Baseline (Day 1) and Week 52
Change From Baseline in St. Georges Respiratory Questionnaire (SGRQ) Total Score at Week 52
Timeframe: Baseline (Day 1) and Week 52
Change From Baseline in Asthma Control Questionnaire (ACQ) Score at Week 52
Timeframe: Baseline (Day 1) and Week 52
Number of Participants with Adverse Events (AEs) Over 52 Weeks
Timeframe: Up to Week 52
Number of Participants with Overall Severe Adverse Events Over 52 Weeks
Timeframe: Up to Week 52
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2025-14-07
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
- Randomized trials of children or adults with severe asthma that were treated with respiratory biologics or biosimilars (alone or in combination with other treatments) that are currently approved, recommended or under investigation, including: Depemokimab, mepolizumab, dupilumab, omalizumab, reslizumab, benralizumab, tezepelumab, tozorakimab, and clazakizumab.
- Populations other than severe asthma and/or participants who are ineligible for treatment with respiratory biologics or biosimilars.
Inclusion and exclusion criteria
Inclusion criteria:
- Randomized trials of children or adults with severe asthma that were treated with respiratory biologics or biosimilars (alone or in combination with other treatments) that are currently approved, recommended or under investigation, including: Depemokimab, mepolizumab, dupilumab, omalizumab, reslizumab, benralizumab, tezepelumab, tozorakimab, and clazakizumab.
Exclusion criteria:
- Populations other than severe asthma and/or participants who are ineligible for treatment with respiratory 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
Recruitment complete
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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