Phase 3
N=400
Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT03927157 ↗Enrolled (actual)
400
Serious AEs
13.0%
Results posted
Jul 2025
Primary outcome: Primary: Annual Asthma Exacerbation Rate (AERR) — 0.42; 1.63 Events per year — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Experimental: Tezepelumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annual Asthma Exacerbation Rate (AERR) |
0.42; 1.63 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Pre-dose/Pre-bronchodilator (Pre-BD) Forced Expiratory Volume in 1 Second (FEV1) at Week 52 |
0.35; 0.11 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Standardized Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ(S)+12) Total Score at Week 52 |
1.29; 0.94 | 0.001 sig |
| SECONDARY Mean Change From Baseline in Asthma Control Questionnaire-6 (ACQ-6) Score at Week 52 |
-1.34; -1.03 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Weekly Mean Daily Asthma Symptom Diary Score at Week 52 |
-0.61; -0.44 | 0.001 sig |
| SECONDARY Time to First Asthma Exacerbation |
45; 89 | — |
| SECONDARY Mean Change From Baseline in Fractional Exhaled Nitric Oxide at Week 52 |
-15.88; -3.15 | — |
| SECONDARY Number of Participants With Asthma Specific Resource Utilization Over 52 Weeks |
4; 13; 5; 11; 36; 75 | — |
| SECONDARY Pharmacokinetics of Tezepelumab |
0; 21.3513; 21.2222; 1.4450 | — |
| SECONDARY Mean Change From Baseline in EQ-5D-5L VAS Score at Week 52 |
12.80; 9.67 | — |
| SECONDARY Mean Change From Baseline in Blood Eosinophils (Cells/uL) at Week 52 |
-193.44; -38.86 | — |
| SECONDARY Mean Change From Baseline in Total Serum IgE (IU/mL) at Week 52 |
-92.77; 0.30 | — |
| SECONDARY Mean Change From Baseline in Night Time Awakenings (Percentage) at Week 52 |
-18.74; -15.99 | — |
| SECONDARY Immunogenicity of Tezepelumab |
11; 18; 3; 7; 10; 14 | — |
| SECONDARY Mean Change From Baseline in Daily Rescue Medication Use (Weekly Means) at Week 52 |
-0.81; -0.70 | — |
| SECONDARY Mean Change From Baseline in Home Based Morning Peak Expiratory Flow (PEF) at Week 52 |
46.70; 18.96 | — |
| SECONDARY Mean Change From Baseline in Home Based Evening Peak Expiratory Flow (PEF) at Week 52 |
42.14; 16.81 | — |
| SECONDARY Annual Asthma Exacerbation Rate Resulting in Emergency Room Visit or Hospitalization |
0.07; 0.18 | — |
| SECONDARY Proportion of Participants Who Had no Asthma Exacerbations |
74.6; 50.3 | — |
Summary
A Regional, Multicentre, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Severe Uncontrolled Asthma
Eligibility Criteria
Inclusion Criteria
- Age. 18-80
- Documented physician-diagnosed asthma for at least 12 months
- Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months.
- Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
- At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
- Morning pre-BD FEV1 <80% predicted normal
- Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
- Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
- ACQ-6 score ≥1.5 at screening and on day of randomization
Exclusion Criteria
- Pulmonary disease other than asthma.
- History of cancer.
- History of a clinically significant infection.
- Current smokers or participants with smoking history ≥10 pack-yrs.
- History of chronic alcohol or drug abuse within 12 months.
- Hepatitis B, C or HIV.
- Pregnant or breastfeeding.
- History of anaphylaxis following any biologic therapy.
- participant randomized in the current study or previous tezepelumab studies.
Data sourced from ClinicalTrials.gov (NCT03927157). 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.