Phase 2
Completed N=79
Study to Evaluate Efficacy & Safety of Tralokinumab in Subjects With Asthma Inadequately Controlled on Corticosteroids
Source: ClinicalTrials.gov NCT02449473 ↗Enrolled (actual)
79
Serious AEs
1.3%
Results posted
Jan 2019
Primary outcomePrimary: Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils — 1.29; 1.07 Ratio — p=0.3862
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12, Expressed as a Ratio, in Number of Airway Submucosal Eosinophils |
1.29; 1.07 | 0.3862 |
| SECONDARY Change From Baseline to Week 12, Expressed as a Ratio, in Number of Blood Eosinophils |
1.10; 0.91 | 0.0546 |
| SECONDARY Change From Baseline to Week 12, Expressed as a Ratio, in Number of Differential Sputum Eosinophils |
0.20; 0.47 | 0.6334 |
| SECONDARY Change From Baseline to Week 12, Expressed as a Ratio, in Blood Free Eosinophil Cationic Protein (ECP) Concentrations |
1.07; 0.92 | 0.3769 |
| SECONDARY Change From Baseline to Week 12, Expressed as a Ratio, in Sputum Free ECP Concentrations |
0.66; 1.83 | 0.1126 |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 75 years
- Documented physician-diagnosed asthma for at least 12 months prior to enrolment (v1)
- Documented treatment with an asthma controller regimen requiring treatment with ICS (minimum dose of ≥ 250 ug fluticasone propionate via dry powder inhaler equivalents total daily dose) alone or in combination ≥ 6 months and that has been taken at a stable dose for at least 1 month prior to enrolment (v1)
- Additional maintenance asthma controller medications must be given at a stable dose for at least 1 month prior to v1.
- At enrolment (v1) the subject must have a predicted normal value (PNV) for the pre-bronchodilator (BD) FEV1>50% and more than 1L.
- Post-BD reversibility in FEV1 of ≥12% and ≥200 mL at enrolment (v1).
Exclusion Criteria
- History of interstitial lung disease, chronic obstructive pulmonary disease (COPD), or other clinically significant lung disease other than asthma.
- History of anaphylaxis following any biologic therapy.
- Hepatitis B, C or HIV
- Pregnant or breastfeeding
- History of cancer
- Current tobacco smoking or a history of tobacco smoking for >10 pack-years.
- Previous receipt of tralokinumab
Data sourced from ClinicalTrials.gov (NCT02449473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.