Phase 3
N=298
Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT05274815 ↗Enrolled (actual)
298
Serious AEs
9.4%
Results posted
Dec 2025
Primary outcome: Primary: Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52 — 32.2; 50.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tezepelumab (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52 |
32.2; 50.3 | — |
| PRIMARY Proportion of the Participants Who Reduced Daily Prescribed Maintenance OCS Dose to ≤5 mg/Day Without Loss of Asthma Control at Week 28 and Week 52 |
88.9; 89.9 | — |
| SECONDARY Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52 |
0.66; 0.57 | — |
| SECONDARY Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks |
0.13; 0.11 | — |
| SECONDARY Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks |
0.06; 0.05 | — |
| SECONDARY Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks |
76.0; 66.9 | — |
| SECONDARY Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks |
95.5; 92.7 | — |
| SECONDARY Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks |
97.9; 96.0 | — |
| SECONDARY Proportion of the Participants With ≥50% Reduction From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52 |
76.8; 81.9 | — |
| SECONDARY Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52 |
35.2; 14.1; 27.5; 8.1; 15.1; 52.0 | — |
| SECONDARY Absolute Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52 |
-6.951; -7.704 | — |
| SECONDARY Percent Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52 |
-61.919; -69.844 | — |
| SECONDARY Change From Baseline in Post-bronchodilator FEV1 at Week 28 and Week 52 |
0.0885; 0.0737 | — |
| SECONDARY Change From Baseline in ACQ-6 at Week 28 and Week 52 |
-1.12; -1.20 | — |
| SECONDARY Change From Baseline in Standardised AQLQ(s)+12 Total Score at Week 28 and Week 52 |
1.1455; 1.1932 | — |
| SECONDARY Change From Baseline in SGRQ Total Score at Week 28 and Week 52 |
-16.2919; -16.6593 | — |
Summary
This is a study designed to evaluate efficacy and safety of Tezepelumab in reducing oral corticosteroid use in adult patients with severe asthma who are receiving oral corticosteroids with or without additional asthma controller medications.
Eligibility Criteria
Main inclusion criteria:
- Age 18-80 years.
- Documented physician diagnosed asthma requiring continuous treatment with high-dose ICS plus a LABA for at least 6 months prior to Visit 1. The ICS and LABA can be contained within a combination product or given by separate inhalers.
- Documented long-term OCS therapy for asthma, equivalent to a daily dose of at least 5 mg and up to 40 mg of prednisone/prednisolone for at least 3 continuous months directly preceding Visit 1.
- Participant should be on a stable maintenance OCS dose for at least 4 weeks prior to Visit 1.
- Documented history of at least 1 asthma exacerbation event within 12 months prior to Visit 1.
Other inclusion criteria per protocol apply.
Main exclusion criteria:
- Pulmonary disease or systemic diseases, other than asthma associated with elevated peripheral EOS counts.
- Any disorder or major physical impairment that is not stable and could affect the safety of the participant throughout the study, influence the findings of the study or the interpretation, or impede the participant's ability to complete the entire duration of study.
- History of cancer.
- History of a clinically significant infection requiring treatment with antibiotics, antiviral or additional corticosteroid medications finalised 1 day during the conduct of the study.
- Coexistent inflammatory conditions for which long-term OCS doses are part of their maintenance treatment.
- Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational nonbiologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1. Participants enrolled in current or previous tezepelumab studies will not be included.
- Concurrent enrolment in another clinical study involving an IP.
- Treatment with systemic immunosuppressive/immunomodulating drugs, except for OCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
- History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy.
- Positive hepatitis B surface antigen, or hepatitis C virus antibody serology at screening, or a positive medical history for hepatitis B or C.
- Pregnant, breastfeeding, or lactating women.
Other exclusion criteria per protocol apply.
Data sourced from ClinicalTrials.gov (NCT05274815). 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.