drugset / Trial / NCT04718389
A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
RandomizedParallel-groupDouble-blindTreatment
Summary
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.
Timeline
- Start
- 2021-01-26
- Primary completion
- 2025-09-14
- Completion
- 2025-09-14
Publications
- Background Chupp G, Nagase H, Skowasch D, Devouassoux G, Cote A, Jackson DJ, Jackson DJ, Wechsler ME, Imber V, McGinniss JE, O K S, Howarth P, Pavord ID; NIMBLE Study Investigators. Switching to twice-yearly depemokimab from mepolizumab/benralizumab in severe asthma: a multicenter, randomized, double-blind, phase 3A clinical trial (NIMBLE). Am J Respir Crit Care Med. 2026 May 1;212(5):921-935. doi: 10.1093/ajrccm/aamag031.
- Seluk L, Davis AE, Rhoads S, Wechsler ME. Novel asthma treatments: Advancing beyond approved novel step-up therapies for asthma. Ann Allergy Asthma Immunol. 2025 Jan;134(1):9-18. doi: 10.1016/j.anai.2024.09.016. Epub 2024 Oct 10.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Benralizumab | Monoclonal antibody | 30 mg | Subcutaneous |
| Subject | Depemokimab | Protein / enzyme biologic | 100 mg | Subcutaneous |
| Comparator | Mepolizumab | Monoclonal antibody | 100 mg | Subcutaneous |