Mode
Text Size
Log in / Sign up
Phase 3 N=400 Randomized Triple-blind Treatment

Study to Evaluate Tezepelumab in Adults With Severe Uncontrolled Asthma

Asthma

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

Back to search