A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype

Conditions

• Asthma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• GSK3511294 (Depemokimab) — BIOLOGICAL
  GSK3511294 (Depemokimab) 100 mg SC along with the placebo and SOC will be administered.
• Mepolizumab — BIOLOGICAL
  Mepolizumab 100 mg SC will be administered in a single-use PFS.
• Benralizumab — BIOLOGICAL
  Benralizumab 30 mg will be administered in a single-use PFS.
• Placebo — BIOLOGICAL
  Placebo will be a sterile liquid formulation.
• Standard of care (SoC) — DRUG
  Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
• Pre-filled Syringes (PFS) — DEVICE
  PFS will include glass barrel with pre-staked needle and plunger.

Study Details

This study will assess whether switching participants who have benefitted from mepolizumab or benralizumab to GSK3511294 (Depemokimab) is non-inferior to maintaining current treatment on the annualized rate of clinically significant exacerbations in participants with severe asthma with an eosinophilic phenotype. Throughout the study, all participants will continue their non-biologic Baseline standard of care (SoC) asthma treatment.

Key Dates

Start date

Jan 26, 2021

Status verified

Apr 2026

Primary completion

Sep 14, 2025

Completion

Sep 14, 2025

Study Design

Enrollment

1,717 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Depemokimab 100mg SC
  Participants received GSK3511294 (Depemokimab) 100 milligrams (mg) subcutaneous (SC) injection administered every 26 weeks (week 0 and week 26) alongside placebo SC treatment matching the active comparator (participant's anti-IL-5/5R treatment prior to randomisation: either placebo matching mepolizumab every 4 weeks or placebo matching benralizumab every 8 weeks).
• Active Comparator: Mepolizumab 100 mg / Benralizumab 30 mg SC
  Participants received their existing active comparator (either mepolizumab 100 mg every 4 weeks or benralizumab 30 mg every 8 weeks) according to the participant's treatment prior to randomisation plus placebo SC matching GSK3511294 (Depemokimab) administered every 26 weeks.

Primary Outcome Measure

Annualized Rate of Clinically Significant Exacerbations Over 52 Weeks [ Time Frame: Up to Week 52 ]

Locations (119)

Related coverage on Hipa.ai

• Depemokimab Phase 3 for Severe Asthma Misses Non-Inferiority Endpoint
  Depemokimab · May 18, 2026 · ClinicalTrials.gov
• Depemokimab Phase 3 Trial for Severe Eosinophilic Asthma Completes Primary Study
  Depemokimab · Sep 14, 2025 · ClinicalTrials.gov

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