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NCT03562195
A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma
Phase 3 trial testing Mepolizumab 100 milligrams in Asthma in 300 participants. Completed in 7 September 2022.
7 September 2022
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 300 |
| Start date | 29 August 2018 |
| Primary completion | 7 September 2022 |
| Estimated completion | 7 September 2022 |
| Sites | 42 locations across China |
Drugs / interventions tested
- Mepolizumab 100 milligrams — full drug profile →
- Placebo
- Salbutamol (salbutamol) — full drug profile →
Conditions studied
- Asthma — all drugs for Asthma →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
12 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Mepolizumab, a humanized monoclonal antibody, has been developed as an add-on treatment for subjects with severe asthma with eosinophilic inflammation. Current asthma treatment guidelines offer minimal options for the severe asthmatic subjects on intensive therapy with frequent exacerbations. There is a significant unmet medical need to provide better treatment options for this segment of the asthma population. Thus, this study is designed to evaluate the efficacy and safety of mepolizumab in Chinese severe asthmatic subjects with eosinophilic inflammation. A total number of 300 subjects will be randomized in 1:1 ratio to receive either mepolizumab or placebo along with existing standard of care therapy. The maximum study duration will be 56 weeks.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Efficacy and safety of mepolizumab in a Chinese population with severe asthma: a phase III, randomised, double-blind, placebo-controlled trial.
Chen R, Wei L, Dai Y, Wang Z, et al · · 2024 · cited 8× · PMID 38770009 · DOI 10.1183/23120541.00750-2023 -
Taking a Breather: Advances in Interleukin 5 Inhibition for Asthma Relief.
Massey OW, Suphioglu C. · · 2022 · cited 6× · PMID 36232470 · DOI 10.3390/ijms231911166 -
Clinical Remission Outcome in Chinese Patients With Severe Asthma With an Eosinophilic Phenotype Receiving Mepolizumab: A <i>Post-hoc</i> Analysis of a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial.
Chen R, Dai Y, Yang D, Liu C, et al · · 2025 · cited 2× · PMID 40736776 · DOI 10.4168/aair.2025.17.4.473 -
Biologics to Treat Severe Asthma in Children and Adolescents: A Practical Update.
Marseglia GL, Licari A, Tosca MA, Ciprandi G. · · 2020 · cited 2× · PMID 35921565 · DOI 10.1089/ped.2020.1212 -
Cost-effectiveness analysis of mepolizumab among patients with severe asthma from the Chinese societal perspective.
Shi C, Wang Y, Tan C, Zeng X, et al · · 2026 · PMID 42127033 · DOI 10.1371/journal.pone.0348955
Verify or expand the search:
- PubMed search for NCT03562195
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other GlaxoSmithKline trials
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03562195 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 19 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03562195.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing