drugset / Trial / NCT04719832
Placebo-controlled Efficacy and Safety Study of GSK3511294 (Depemokimab) in Participants With Severe Asthma With an Eosinophilic Phenotype
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study that aims to assess the efficacy and safety of GSK3511294 (Depemokimab) in participants with severe uncontrolled asthma with an eosinophilic phenotype
Timeline
- Start
- 2021-03-17
- Primary completion
- 2023-11-21
- Completion
- 2023-11-21
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs GSK3511294; p < 0.001; Rate Ratio 0.42 (95% CI 0.30 to 0.59); Negative binomial distribution NCT04719832 ↗
paper Depemokimab reduced the annualized rate of exacerbations among patients with severe asthma with an eosinophilic phenotype. PMID 39248309 ↗
Publications
- Keeley T, O'Neill D, Dikariyanto V, Dumi G, Fromy P, Markov F, Richards A, Alfonso-Cristancho R. Validity, reliability, and longitudinal measurement properties of the Asthma Daytime and Nighttime Symptom Diaries in patients with moderate-to-severe asthma. J Patient Rep Outcomes. 2026 May 20;10(1):89. doi: 10.1186/s41687-026-01066-5.
- Jackson DJ, Bourdin A, Blackorby A, Leslie A, Vichiendilokkul A, Howarth P, Karkoszka N, Fujieda S, Cornet M. Safety and Tolerability of Twice-Yearly Depemokimab in Patients with Asthma and Chronic Rhinosinusitis with Nasal Polyps: Pooled Results from SWIFT-1/-2 and ANCHOR-1/-2. Adv Ther. 2026 Feb;43(2):880-897. doi: 10.1007/s12325-025-03457-4. Epub 2025 Dec 29.
- Jackson DJ, Wechsler ME, Jackson DJ, Bernstein D, Korn S, Pfeffer PE, Chen R, Saito J, de Luiz Martinez G, Dymek L, Jacques L, Bird N, Schalkwijk S, Smith D, Howarth P, Pavord ID; SWIFT-1 and SWIFT-2 Investigators; SWIFT-1 Investigators; SWIFT-2 Investigators. Twice-Yearly Depemokimab in Severe Asthma with an Eosinophilic Phenotype. N Engl J Med. 2024 Dec 19;391(24):2337-2349. doi: 10.1056/NEJMoa2406673. Epub 2024 Sep 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Depemokimab | Protein / enzyme biologic | 100 mg | Subcutaneous |