Phase 3
Completed N=856
A Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Adults and Adolescents With Uncontrolled Asthma
Uncontrolled Asthma
Source: ClinicalTrials.gov NCT02194699 ↗
Enrolled (actual)
856
Serious AEs
8.7%
Results posted
Mar 2018
Primary outcomePrimary: Annualised Asthma Exacerbation Rate (AAER) up to Week 52 — 0.80; 0.95; 0.87; 0.77 Events/year — p=0.4656
◆ 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 |
0.80; 0.95; 0.87; 0.77; 0.84; 0.82 | 0.4656 |
| SECONDARY Percent Change From Baseline to Week 52 in Pre-dose/Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1) |
18.769; 16.632; 13.103; 8.395; 14.546; 10.528 | 0.6033 |
| SECONDARY Change From Baseline to Week 52 in Total Asthma Symptom Score (Bi-weekly Means) |
-1.18; -1.06; -0.98; -1.02; -1.04; -1.02 | 0.1456 |
| SECONDARY Change From Baseline to Week 52 in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score |
1.35; 1.20; 1.13; 1.23; 1.18; 1.21 | 0.0874 |
| SECONDARY Change From Baseline to Week 52 in Asthma Control Questionnaire-6 (ACQ-6) Score |
-1.26; -1.14; -1.07; -1.11; -1.12; -1.11 | 0.0400 sig |
| SECONDARY AAER Associated With an ER/UC Visit, or a Hospitalisation up to Week 52 |
0.06; 0.16; 0.09; 0.11; 0.08; 0.12 | 0.0576 |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimension 5 Levels (EQ-5D-5L) Visual Analogue Scale (VAS) Scores at Week 52 |
14.58; 11.58; 11.67; 12.01; 12.46; 11.66 | — |
| SECONDARY Change From Baseline in Total Asthma Rescue Medication Use at Week 52 (Bi-weekly Means) |
-2.86; -1.73; -2.01; -2.08; -2.25; -1.97 | 0.0360 sig |
| SECONDARY Change From Baseline in Home Peak Expiratory Flow (PEF) (Morning and Evening) at Week 52 |
22.35; 18.80; 6.72; 6.10; 10.66; 9.43 | 0.5094 |
| SECONDARY Change From Baseline in Night-time Awakenings Due to Asthma Requiring Rescue Medication Use at Week 52 (Bi-weekly Means [Percentage]) |
-37.86; -34.06; -34.65; -35.67; -35.60; -35.05 | 0.1099 |
| SECONDARY Number of Patients With ≥1 Asthma Exacerbation up to Week 52 |
38; 50; 125; 117; 163; 171 | 0.3440 |
| SECONDARY Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questions (WPAI+CIQ): Productivity Loss at Week 52 |
22.51; 28.15; 23.36; 31.05; 23.43; 30.17 | — |
| SECONDARY WPAI+CIQ: Activity Impairment at Week 52 |
20.89; 25.28; 20.50; 26.49; 20.68; 26.11 | — |
| SECONDARY Asthma-related Healthcare Encounters by Type up to Week 52 |
14; 21; 21; 20; 35; 41 | — |
| SECONDARY Asthma-related Healthcare Encounters by Type up to Week 52: Hospitalisations |
82; 175; 334; 414; 417; 590 | — |
| SECONDARY Asthma-related Healthcare Encounters by Type up to Week 52: Spirometry |
148; 151; 284; 270; 434; 426 | — |
| SECONDARY Serum Trough Concentration (Ctrough) of Tralokinumab During the Treatment Period up to Week 72 |
NA; NA; NA; 24.049; 20.916; 21.690 | — |
| SECONDARY Incidence Rate of Positive Anti-drug Antibodies (ADAs) Including the Characterization of Their Neutralizing Potential |
7; 8; 5; 3; 2; 5 | — |
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 (NCT02194699) 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.