NCT02449473: MESOS

Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids

Completed Phase 2 Results posted Last updated 8 January 2019

What this trial tests

Phase 2 trial testing Tralokinumab in Asthma in 79 participants. Completed in 21 June 2017.

Timeline

29 September 2015

Primary endpoint
21 June 2017

21 June 2017

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	79
Start date	29 September 2015
Primary completion	21 June 2017
Estimated completion	21 June 2017
Sites	15 locations across Denmark, Canada, United Kingdom

Drugs / interventions tested

• Tralokinumab (TRALOKINUMAB) — full drug profile →
• Placebo

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 75, 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 to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils Primary · Baseline (Week 0) and Week 12

The number of airway submucosal eosinophils per millimetre squared (mm\^2) was determined by microscopic evaluation of bronchoscopic biopsies. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of airway submucosal eosinophils is presented as geometric mean ± standard deviation (SD) of log values.

Group	Value	95% CI
Tralo 300 mg Q2W	1.29	± 2.06
Placebo	1.07	± 1.87

Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils Secondary · Baseline (Week 0) and Week 12

The blood eosinophil count was obtained from the total and differential white blood cell counts. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of blood eosinophils is presented as geometric mean ± SD of log values.

Group	Value	95% CI
Tralo 300 mg Q2W	1.10	± 0.38
Placebo	0.91	± 0.46

Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils Secondary · Baseline (Week 0) and Week 12

Sputum induction was performed to obtain satisfactory samples of sputum originating from the airways. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in the number of eosinophils in induced sputum is presented as geometric mean ± SD of log values.

Group	Value	95% CI
Tralo 300 mg Q2W	0.20	± 3.16
Placebo	0.47	± 3.63

Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations Secondary · Baseline (Week 0) and Week 12

ECP concentrations were determined to assess evidence of activation of eosinophils in blood. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in blood free ECP concentrations is presented as geometric mean ± SD of log values.

Group	Value	95% CI
Tralo 300 mg Q2W	1.07	± 0.40
Placebo	0.92	± 0.47

Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations Secondary · Baseline (Week 0) and Week 12

ECP concentrations were determined to assess evidence of activation of eosinophils in sputum. The ratio of post-randomisation value at Week 12 to baseline value was computed as (Week 12 value / baseline value). The change from baseline to Week 12 (ratio) in sputum free ECP concentrations is presented as geometric mean ± SD of log values.

Group	Value	95% CI
Tralo 300 mg Q2W	0.66	± 1.21
Placebo	1.83	± 1.41

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tralo 300 mg Q2W

Serious: 0/39 (0%)

Deaths: 0/39

Placebo

Serious: 1/40 (3%)

Deaths: 0/40

Serious adverse events (1 terms)

Reaction	System	Tralo 300 mg Q2W	Placebo
Asthma	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (20 terms — click to expand)

Reaction	System	Tralo 300 mg Q2W	Placebo
Viral upper respiratory tract infection	Infections and infestations	—	—
Headache	Nervous system disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Injection site erythema	General disorders	—	—
Fatigue	General disorders	—	—
Procedural pain	Injury, poisoning and procedural complications	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Influenza	Infections and infestations	—	—
Nausea	Gastrointestinal disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Injection site pain	General disorders	—	—
Injection site pruritus	General disorders	—	—
Injection site swelling	General disorders	—	—
Non-cardiac chest pain	General disorders	—	—
Weight increased	Investigations	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Asthma.

Data from ClinicalTrials.gov NCT02449473 adverse events section.

Sponsor's own description

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, 12-Week, Phase 2 Study to Evaluate the Effect of Tralokinumab on Airway Inflammation in Adults with Asthma Inadequately Controlled on Inhaled Corticosteroid.

Publications & conference data

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

1. Interleukin-13 in Asthma and Other Eosinophilic Disorders.
   Doran E, Cai F, Holweg CTJ, Wong K, et al · · 2017 · cited 101× · PMID 29034234 · DOI 10.3389/fmed.2017.00139
2. Effect of tralokinumab, an interleukin-13 neutralising monoclonal antibody, on eosinophilic airway inflammation in uncontrolled moderate-to-severe asthma (MESOS): a multicentre, double-blind, randomised, placebo-controlled phase 2 trial.
   Russell RJ, Chachi L, FitzGerald JM, Backer V, et al · · 2018 · cited 89× · PMID 29793857 · DOI 10.1016/s2213-2600(18)30201-7
3. IL-4/IL-13 axis as therapeutic targets in allergic rhinitis and asthma.
   Nur Husna SM, Md Shukri N, Mohd Ashari NS, Wong KK. · · 2022 · cited 65× · PMID 35663523 · DOI 10.7717/peerj.13444
4. Eosinophilic Asthma: Pathophysiology and Therapeutic Horizons.
   Hussain M, Liu G. · · 2024 · cited 60× · PMID 38474348 · DOI 10.3390/cells13050384
5. Anti-interleukin-13 and anti-interleukin-4 agents versus placebo, anti-interleukin-5 or anti-immunoglobulin-E agents, for people with asthma.
   Gallagher A, Edwards M, Nair P, Drew S, et al · · 2021 · cited 19× · PMID 34664263 · DOI 10.1002/14651858.cd012929.pub2
6. Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program.
   Panettieri RA, Wang M, Braddock M, Bowen K, et al · · 2018 · cited 17× · PMID 29536781 · DOI 10.2217/imt-2017-0191
7. Targeting IL-13 and IL-4 in Asthma: Therapeutic Implications on Airway Remodeling in Severe Asthma.
   Sahnoon L, Bajbouj K, Mahboub B, Hamoudi R, et al · · 2025 · cited 16× · PMID 40257546 · DOI 10.1007/s12016-025-09045-2
8. Feno differentiates epithelial gene expression clusters: Exploratory analysis from the MESOS randomized controlled trial.
   Diver S, Sridhar S, Khalfaoui LC, Russell RJ, et al · · 2022 · cited 12× · PMID 35537502 · DOI 10.1016/j.jaci.2022.04.024