Phase 3
Completed N=1,207
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Uncontrolled Asthma
Source: ClinicalTrials.gov NCT02161757 ↗
Enrolled (actual)
1,207
Serious AEs
10.6%
Results posted
Apr 2018
Primary outcomePrimary: Annualised Asthma Exacerbation Rate (AAER) up to Week 52 — 0.56; 0.54; 0.60 Events/year — p=0.5859
◆ Published Evidence
Highly cited
227citations · ~28 / year
Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials.
Summary
A 52-Week, Multicentre, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents with Asthma Inadequately Controlled on Inhaled Corticosteroid Plus Long-Acting β2-Agonist
Linked Publications (4)
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Tralokinumab for severe, uncontrolled asthma (STRATOS 1 and STRATOS 2): two randomised, double-blind, placebo-controlled, phase 3 clinical trials.
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Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program.
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Evaluation of Antibody Properties and Clinically Relevant Immunogenicity, Anaphylaxis, and Hypersensitivity Reactions in Two Phase III Trials of Tralokinumab in Severe, Uncontrolled Asthma.
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Application of structured statistical analyses to identify a biomarker predictive of enhanced tralokinumab efficacy in phase III clinical trials for severe, uncontrolled asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualised Asthma Exacerbation Rate (AAER) up to Week 52 |
0.56; 0.54; 0.60 | 0.5859 |
| SECONDARY Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) |
16.366; 12.099; 10.136 | — |
| SECONDARY Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means) |
-1.09; -1.00; -1.03 | — |
| SECONDARY Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score |
1.18; 1.16; 1.03 | — |
| SECONDARY Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score |
-1.19; -1.12; -1.02 | — |
| SECONDARY AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52 |
0.04; 0.06; 0.07 | 0.0369 sig |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52 |
10.68; 9.00; 10.06 | — |
| SECONDARY Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means) |
-2.18; -2.15; -2.04 | — |
| SECONDARY Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 |
12.95; 7.55; 5.23; 8.89; 0.68; -0.28 | — |
| SECONDARY Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage]) |
-37.63; -35.17; -36.00 | — |
| SECONDARY Number of Patients With ≥1 Asthma Exacerbation up to Week 52 |
128; 124; 133 | 0.732 |
| SECONDARY Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 |
27.71; 28.48; 31.25; 33.13; 31.79; 32.31 | — |
| SECONDARY WPAI+CIQ: Activity Impairment at Week 52 |
23.25; 23.53; 27.01; 29.29; 27.50; 28.95 | — |
| SECONDARY Asthma-related Healthcare Encounters by Type up to Week 52 |
5; 15; 16; 59; 87; 64 | — |
| SECONDARY Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations |
270; 345; 482 | — |
| SECONDARY Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry |
489; 520; 502 | — |
| SECONDARY Serum Trough Concentration (Ctrough) of Tralokinumab During the Study Period up to Week 72 |
NA; NA; 34.690; 13.151; 55.262; 19.243 | — |
| SECONDARY Number of Patients Positive for Anti-drug Antibodies (ADAs) |
7; 7; 9; 3; 2; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Age 12 -75
- Documented physician-diagnosed asthma.
- Documented treatment with ICS at a total daily dose corresponding to ≥500μg fluticasone propionate dry powder formulation equivalents) and a LABA
- Morning pre-BD FEV1 value of ≥40 and <80% value (<90% for patients 12 to 17 years of age) of their PNV.
- Post-BD reversibility of ≥12% and ≥200 mL in FEV1
- ACQ-6 score ≥1.5
Exclusion Criteria
- Pulmonary 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 (NCT02161757) and the linked publication. 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.