Phase 3
Completed N=150
Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
Source: ClinicalTrials.gov NCT03406078 ↗Enrolled (actual)
150
Serious AEs
18.7%
Results posted
Dec 2021
Primary outcomePrimary: Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control — 40; 35; 5; 4 Participants — p=0.434
◆ Published Evidence
Highly cited
138citations · ~46 / year
Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study.
Summary
Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
Linked Publications (3)
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Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study.
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Evaluation of the oral corticosteroid-sparing effect of tezepelumab in adults with oral corticosteroid-dependent asthma (SOURCE): a randomised, placebo-controlled, phase 3 study.
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SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid use in adults with oral corticosteroid dependent asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Categorized Percent Reduction From Baseline in the Daily OCS Dose While Not Losing Asthma Control |
40; 35; 5; 4; 10; 14 | 0.434 |
| SECONDARY Annualised Asthma Exacerbation Rate (AAER) |
1.38; 2.00 | — |
| SECONDARY Proportion of Subjects With 100% Reduction From Baseline in Daily OCS Dose at Week 48 |
54.1; 46.1 | — |
| SECONDARY Proportion of Subjects With Daily OCS Dose ≤5 mg at Week 48 |
71.6; 72.4 | — |
| SECONDARY Proportion of Subjects With ≥50% Reduction From Baseline in Daily OCS Dose at Week 48 |
74.3; 69.7 | — |
| SECONDARY Change From Baseline in Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) |
0.21; -0.04 | — |
| SECONDARY Change From Baseline in Weekly Mean Daily Asthma Symptom Score Via the Daily Asthma Symptom Diary |
-0.36; -0.26 | — |
| SECONDARY Change From Baseline in Weekly Mean Rescue Medication Use |
-0.85; -0.37 | — |
| SECONDARY Change From Baseline in Weekly Mean Home Peak Expiratory Flow (PEF) (Morning and Evening) |
13.29; -9.71; 10.05; -11.37 | — |
| SECONDARY Change From Baseline in Weekly Mean Number of Night-time Awakening Due to Asthma |
-15.71; -12.79 | — |
| SECONDARY Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score |
-0.87; -0.51 | — |
| SECONDARY Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(s)+12) Total Score |
0.94; 0.58 | — |
| SECONDARY Change From Baseline in European Quality of Life - 5 Dimensions 5 Levels Questionnaire (EQ-5D-5L) Score |
0.07; 0.00 | — |
| SECONDARY Number of Participants With Asthma Specific Resource Utilizations |
5; 10; 4; 7; 29; 41 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Questionnaire and Classroom Impairment Questionnaire (WPAI+CIQ) Score |
-6.27; -9.66; -10.00; -13.2; -7.8 | — |
| SECONDARY Change From Baseline in FENO |
-11.71; -1.40 | — |
| SECONDARY Change From Baseline in Peripheral Blood Eosinophils |
-83.79; 33.38 | — |
| SECONDARY Change From Baseline From Total Serum IgE |
-80.66; 37.77 | — |
| SECONDARY PK: Serum Trough Concentrations |
0; 10.3298; 17.9626; 18.9210; 16.7095; 13.9224 | — |
| SECONDARY Immunogenicity: Incidence of Anti-drug Antibodies (ADA) |
3; 2; 2; 2; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have received a physician-prescribed medium- or high-dose ICS as per GINA guideline for at least 12 months
- Subjects must have received physician prescribed LABA and high dose ICS (total daily dose >500μg fluticasone propionate dry powder formulation equivalent) for at least 3 months. The ICS and LABA can be parts of a combination product, or given by separate inhalers.
- Additional maintenance asthma controller medications are allowed according to standard practice of care i.e., leukotriene receptor antagonists (LTRAs), theophylline, long-acting muscarinic antagonists (LAMAs), secondary ICS and cromones. The use of these medications must be documented for at least 3 months
- Subjects must have received OCS for the treatment of asthma for at least 6 months prior to screening and on a stable dose of between ≥ 7.5 to ≤ 30mg (prednisone or prednisolone equivalent) daily or daily equivalent for at least 1 month. The OCS dose may be administered every other day (or different doses every other day); Average dose over two days = The daily dose.
- Morning pre-bronchodilator (BD) FEV1 must be 1 day during the conduct of the study.
- Clinically significant asthma exacerbation, in the opinion of the Investigator, including those requiring use of systemic corticosteroids or increase in the maintenance dose of OCS within 30 days
Data sourced from ClinicalTrials.gov (NCT03406078) 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.