A multi-centre, single arm, open-label extension study to evaluate the long-term safety of GSK3511294 (Depemokimab) in adult and adolescent participants with severe asthma with an eosinophilic phenotype from studies 206713 or 213744

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505203-23-01

Acronym

212895

Enrollment

372

Registered

2024-02-14

Start date

2021-07-26

Completion date

2025-05-19

Last updated

2025-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe asthma with an eosinophilic phenotype

Brief summary

Incidence of adverse events (AEs)/serious adverse events (SAEs) over 52 weeks, Incidence of immunogenicity as measured by the presence of anti-drug antibody (ADA)/ neutralising antibody (Nab) to GSK3511294 over 52 weeks

Detailed description

Annualized rate of Clinically significant exacerbations over 52 weeks, Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at discrete timepoints during the 52 week period, Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52, Change from Baseline in prebronchodilator FEV1 at Week 26 and Week 52

Interventions

None listed

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events (AEs)/serious adverse events (SAEs) over 52 weeks, Incidence of immunogenicity as measured by the presence of anti-drug antibody (ADA)/ neutralising antibody (Nab) to GSK3511294 over 52 weeks	—

Secondary

Measure	Time frame
Annualized rate of Clinically significant exacerbations over 52 weeks, Change from Baseline in Asthma Control Questionnaire-5 (ACQ-5) score at discrete timepoints during the 52 week period, Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 26 and Week 52, Change from Baseline in prebronchodilator FEV1 at Week 26 and Week 52	—

Countries

Czechia, France, Germany, Hungary, Italy, Poland, Spain

Outcome results