NCT02808819 (MELTEMI) is a Phase 3 clinical trial of Benralizumab in Asthma, sponsored by AstraZeneca.

Who is sponsoring NCT02808819?

NCT02808819 is sponsored by AstraZeneca.

What drugs are being tested in NCT02808819?

Interventions in NCT02808819: Benralizumab, Benralizumab.

Is NCT02808819 still recruiting?

NCT02808819 is currently completed. Last updated 13 April 2021.

Are results published for NCT02808819?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-04-13 · How we verify

NCT02808819: MELTEMI

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Safety Extension Study With Benralizumab for Asthmatic Adults on Inhaled Corticosteroid Plus Long-acting β2 Agonist

Completed Phase 3 Results posted Last updated 13 April 2021

What this trial tests

Phase 3 trial testing Benralizumab in Asthma in 447 participants. Completed in 18 June 2020.

Timeline

30 June 2016

Primary endpoint
18 June 2020

18 June 2020

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	447
Start date	30 June 2016
Primary completion	18 June 2020
Estimated completion	18 June 2020
Sites	178 locations across France, Russia, Ukraine, Chile, United Kingdom, Germany, Poland, Argentina

Drugs / interventions tested

Benralizumab (BENRALIZUMAB) — full drug profile →
Benralizumab (BENRALIZUMAB) — full drug profile →

Conditions studied

Asthma — all drugs for Asthma →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 130, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Basophils, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Basophils.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	0.014	± 0.0229
Benra 30 mg q.8 Weeks	0.012	± 0.0243
Total	0.013	± 0.0236

Change From Baseline in Leukocytes, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Leukocytes.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	-0.254	± 2.0446
Benra 30 mg q.8 Weeks	-0.498	± 1.7217
Total	-0.377	± 1.8896

Change From Baseline in Lymphocytes, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Lymphocytes.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	-0.098	± 0.5479
Benra 30 mg q.8 Weeks	-0.142	± 0.6544
Total	-0.121	± 0.6038

Change From Baseline in Neutrophils, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Neutrophils.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	-0.237	± 1.8765
Benra 30 mg q.8 Weeks	-0.392	± 1.4802
Total	-0.315	± 1.6866

Change From Baseline in Monocytes, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Monocytes.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	0.055	± 0.1835
Benra 30 mg q.8 Weeks	0.056	± 0.1766
Total	0.055	± 0.1798

Change From Baseline in Platelets, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Platelets.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	9.1	± 41.72
Benra 30 mg q.8 Weeks	11.9	± 36.13
Total	10.5	± 38.98

Change From Baseline in Hematocrit, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Hematocrit.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	-0.002	± 0.0269
Benra 30 mg q.8 Weeks	-0.003	± 0.0260
Total	-0.003	± 0.0264

Change From Baseline in Erythrocytes, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Erythrocytes.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	-0.008	± 0.2922
Benra 30 mg q.8 Weeks	-0.054	± 0.2614
Total	-0.031	± 0.2776

Change From Baseline in Hemoglobin, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in hematologic lab parameter of Hemoglobin.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	2.6	± 8.92
Benra 30 mg q.8 Weeks	1.2	± 8.37
Total	1.9	± 8.66

Change From Baseline in Alanine Aminotransferase (ALT), Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in chemistry test ALT.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	0.007	± 0.2060
Benra 30 mg q.8 Weeks	0.004	± 0.2118
Total	0.005	± 0.2086

Change From Baseline in Aspartate Aminotransferase (AST), Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in chemistry test AST.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	-0.021	± 0.1258
Benra 30 mg q.8 Weeks	-0.018	± 0.1280
Total	-0.020	± 0.1267

Change From Baseline in Bilirubin, Full Analysis Set Primary · From Week 0 to Benralizumab is available in the local market or early discontinuation. Change from week 0 to the end of treatment period/early discontinuation is presented.

Change from baseline in chemistry test Bilirubin.

Group	Value	95% CI
Benra 30 mg q.4 Weeks	-0.451	± 3.0980
Benra 30 mg q.8 Weeks	-0.297	± 3.3972
Total	-0.374	± 3.2486

Adverse events — posted to ClinicalTrials.gov

Time frame: All participants completed treatment period up to Week 184.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Benra 30 mg q.4 Weeks

Serious: 44/220 (20%)

Deaths: 1/220

Benra 30 mg q.8 Weeks

Serious: 47/226 (21%)

Deaths: 0/226

Serious adverse events (89 terms)

Reaction	System	Benra 30 mg q.4 Weeks	Benra 30 mg q.8 Weeks
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Influenza	Infections and infestations	—	—
Asthenia	General disorders	—	—
Pneumonia	Infections and infestations	—	—
Limb injury	Injury, poisoning and procedural complications	—	—
Lower limb fracture	Injury, poisoning and procedural complications	—	—
Hypochromic anaemia	Blood and lymphatic system disorders	—	—
Lymphadenitis	Blood and lymphatic system disorders	—	—
Aortic valve stenosis	Cardiac disorders	—	—
Atrial fibrillation	Cardiac disorders	—	—
Coronary artery occlusion	Cardiac disorders	—	—
Left ventricular failure	Cardiac disorders	—	—
Hyperthyroidism	Endocrine disorders	—	—
Cataract	Eye disorders	—	—
Retinal tear	Eye disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Anal stenosis	Gastrointestinal disorders	—	—
Femoral hernia incarcerated	Gastrointestinal disorders	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Haemorrhoids	Gastrointestinal disorders	—	—
Hiatus hernia	Gastrointestinal disorders	—	—
Large intestine polyp	Gastrointestinal disorders	—	—
Musculoskeletal complication associated with device	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—

Other adverse events (24 terms — click to expand)

Reaction	System	Benra 30 mg q.4 Weeks	Benra 30 mg q.8 Weeks
Nasopharyngitis	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—
Hypertension	Vascular disorders	—	—
Bronchitis	Infections and infestations	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
Sinusitis	Infections and infestations	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Acute sinusitis	Infections and infestations	—	—
Bronchitis bacterial	Infections and infestations	—	—
Rhinitis	Infections and infestations	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Influenza	Infections and infestations	—	—
Pharyngitis	Infections and infestations	—	—
Upper respiratory tract infection bacterial	Infections and infestations	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Influenza like illness	General disorders	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	—	—
Sinusitis bacterial	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Dizziness	Nervous system disorders	—	—
Nasal polyps	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Asthma, Influenza, Asthenia, Pneumonia, Limb injury, Lower limb fracture, Hypochromic anaemia, Lymphadenitis.

Data from ClinicalTrials.gov NCT02808819 adverse events section.

Sponsor's own description

The purpose of this study is to continue to characterize the safety profile of benralizumab administration and monitor the pharmacodynamic activity of the drug in those asthma patients who remain on treatment for at least 16 weeks and not more than 40 weeks in the predecessor study D3250C00021 (BORA, NCT02258542).

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Anti-IL5 therapies for asthma.
Farne HA, Wilson A, Powell C, Bax L, et al · · 2017 · cited 190× · PMID 28933516 · DOI 10.1002/14651858.cd010834.pub3
Benralizumab in the treatment of severe asthma: design, development and potential place in therapy.
Pelaia C, Vatrella A, Bruni A, Terracciano R, et al · · 2018 · cited 54× · PMID 29606855 · DOI 10.2147/dddt.s155307
Safety of Eosinophil-Depleting Therapy for Severe, Eosinophilic Asthma: Focus on Benralizumab.
Jackson DJ, Korn S, Mathur SK, Barker P, et al · · 2020 · cited 53× · PMID 32242310 · DOI 10.1007/s40264-020-00926-3
Anti-IL-5 therapies for asthma.
Farne HA, Wilson A, Milan S, Banchoff E, et al · · 2022 · cited 37× · PMID 35838542 · DOI 10.1002/14651858.cd010834.pub4
Two-Year Integrated Efficacy And Safety Analysis Of Benralizumab In Severe Asthma.
FitzGerald JM, Bleecker ER, Bourdin A, Busse WW, et al · · 2019 · cited 31× · PMID 31849500 · DOI 10.2147/jaa.s227170
Subsets of Eosinophils in Asthma, a Challenge for Precise Treatment.
Novosad J, Krčmová I, Souček O, Drahošová M, et al · · 2023 · cited 16× · PMID 36982789 · DOI 10.3390/ijms24065716

Verify or expand the search:

Other trials of Benralizumab

Trials testing the same drug.

NCT07444567 — Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit Fr · Phase 3 · not yet recruiting
NCT06512883 — A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases · Phase 3 · recruiting
NCT06465485 — STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma · Phase 3 · active not recruiting
NCT06385236 — Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping · Phase 4 · recruiting
NCT05966584 — A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer · Phase 2 · terminated

Other recruiting trials for Asthma

Currently open trials in the same condition.

NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02808819 (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 AstraZeneca
Last refreshed: 13 April 2021

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/NCT02808819.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing