A 52-week, randomised, double-blind, double-dummy, parallel group, multi-centre, non-inferiority study assessing exacerbation rate, additional measures of asthma control and safety in adult and adolescent severe asthmatic participants with an eosinophilic phenotype treated with GSK3511294 (depemokimab) compared with mepolizumab or benralizumab

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510230-84-00

Acronym

206785

Enrollment

750

Registered

2024-06-19

Start date

2021-05-28

Completion date

2025-09-10

Last updated

2025-10-27

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

Annualised rate of clinically significant exacerbations over 52 weeks

Detailed description

Weighted mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score calculated over 52 weeks, Weighted mean change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score calculated over 52 weeks, Weighted mean change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) calculated over 52 weeks

Interventions

DRUGA placebo matching Mepolizumab

DRUGNucala 100 mg solution for injection in pre-filled syringe

DRUGA placebo matching Depemokimab

DRUGGSK3511294

DRUGPlacebo for benralizumab for clinical trials is a sterile liquid solution presented in an accessorized prefilled syringe (apfs) for subcutaneous injection

DRUGFasenra 30 mg solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Annualised rate of clinically significant exacerbations over 52 weeks	—

Secondary

Measure	Time frame
Weighted mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score calculated over 52 weeks, Weighted mean change from baseline in Asthma Control Questionnaire-5 (ACQ-5) score calculated over 52 weeks, Weighted mean change from baseline in pre-bronchodilator forced expiratory volume in one second (FEV1) calculated over 52 weeks	—

Countries

Austria, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Portugal, Slovenia, Spain, Sweden

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026