AsthmaPhase 3WAYFINDERNCT05274815
Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma
A Phase 3 study testing Tezepelumab in people with Asthma, run by AstraZeneca at 77 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tezepelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 77 sitesin 11 countries
- Study dates
- 17 May 2022to 9 Sep 2024
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 < 2 weeks before Visit 1.
- A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
- Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes.
- History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
- Tuberculosis requiring treatment within the 12 months prior to Visit 1.
- History of known immunodeficiency disorder including a positive HIV test at Visit 1.
- Major surgery within 8 weeks prior to Visit 1 or planned surgical procedures requiring general anaesthesia or inpatient status for > 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.
Trial locations and contacts
77 sites in 11 countries.
77 sites in 11 countries
Argentina12 sites
Research Site
Buenos Aires, C1121ABE
Research Site
CABA, 1426
Research Site
CABA, C1012AAR
Research Site
Mendoza, M5500GHB
Research Site
Monte Grande, 1842
Research Site
Pilar, 1629
Research Site
Quilmes, B1878FNR
Research Site
Ranelagh, 1886
Research Site
Rosario, 2000
Research Site
San Fernando, B1646EBJ
Research Site
San Juan Bautista, 1888
Research Site
San Miguel de Tucumán, 4000
Poland10 sites
Research Site
Bychawa, 23100
Research Site
Chmielnik, 26-020
Research Site
Gdansk, 80-952
Research Site
Krakow, 31-011
Research Site
Lodz, 92-213
Research Site
Ostrowiec Świętokrzyski, 27-400
Research Site
Sosnowiec, 41-200
Research Site
Wroclaw, 50-044
Research Site
Wroclaw, 53-301
Research Site
Wroclaw, 54-239
France8 sites
Research Site
Antony, 92160
Research Site
Bordeaux, 33076
Research Site
Brest, 29609
Research Site
Lyon, 69004
Research Site
Marseille, 13915
Research Site
Montpellier
Research Site
Nantes, 44000
Research Site
Nice, 06000
United States7 sites
Research Site
Ann Arbor, Michigan, 48109
Research Site
DuBois, Pennsylvania, 15801
Research Site
Loxahatchee Groves, Florida, 33470
Research Site
Newark, Delaware, 19713
Research Site
Newport Beach, California, 92663
Research Site
The Bronx, New York, 10467
Research Site
Toms River, New Jersey, 08755
Latvia7 sites
Research Site
Daugavpils, LV-5410
Research Site
Daugavpils, LV-5417
Research Site
Jūrmala, LV-2015
Research Site
Riga, LV-1011
Research Site
Riga, LV1002
Research Site
Riga, LV1010
Research Site
Valmiera, LV-4201
Spain7 sites
Research Site
Badalona, 08916
Research Site
Barcelona, 8035
Research Site
Madrid, 28041
Research Site
Oviedo, 33011
Research Site
Santa Cruz de Tenerife, 38010
Research Site
Santander, 39008
Research Site
Seville, 41009
United Kingdom7 sites
Research Site
Belfast, BT97AB
Research Site
Bradford, BD9 6RJ
Research Site
LE3 9QP
Research Site
London, SE1 7EH
Research Site
London, SW3 6HP
Research Site
Nottingham, NG5 1PB
Research Site
Portsmouth, PO6 3LY
Bulgaria6 sites
Research Site
Haskovo, 6305
Research Site
Razgrad, 7200
Research Site
Sofia, 1142
Research Site
Sofia, 1431
Research Site
Sofia, 5000
Research Site
Velika Tarnovo, 5250
Germany5 sites
Research Site
Berlin, 12203
Research Site
Darmstadt, 64283
Research Site
Fürstenwalde, 15517
Research Site
Mainz, 55128
Research Site
Reinfeld (Holstein), 23858
Belgium4 sites
Research Site
Brussels (Woluwé-St-Lambert), 1200
Research Site
Erpent, 5101
Research Site
Ghent, 9000
Research Site
Liège, 4000
Mexico4 sites
Research Site
Chihuahua City, 31000
Research Site
Chihuahua City, 31200
Research Site
Guadalajara, 44100
Research Site
Monterrey, 64360
About this study
Official title: A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants With Severe Asthma on High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Long-term Oral Corticosteroid Therapy (WAYFINDER)
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.
Read the detailed description
This is a multicentre, single-arm, phase 3b study designed to evaluate efficacy and safety of reducing daily oral corticosteroid use after initiation of 210 mg dose of Tezepelumab administered subcutaneously in patients with severe asthma receiving high-dose inhaled corticosteroid plus long-acting β2 agonist and oral corticosteroids with or without additional asthma controller medications.
- Conditions
- Asthma
- Being tested
- Tezepelumab
- Keywords
- Asthma, Severe Asthma, Oral Corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabBiological
Tezepelumab subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Tezepelumab | Experimental | Tezepelumab subcutaneous injection Receives: Biological: Tezepelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52
The proportion (expressed as a percentage) of participants who discontinued OCS without loss of asthma control is presented.
Loss of asthma control was defined as asthma worsening or exacerbation. Asthma worsening was defined by an increase of Asthma Control Questionnaire 6 (ACQ-6) score ≥0.5 from baseline. Asthma exacerbation was defined by worsening of asthma symptoms that led to temporary bolus/burst of systemic corticosteroids (SCS; or a temporary increase in stable OCS background dose) for at least 3 consecutive days (a single depo-injectable dose of corticosteroids being considered equivalent to a 3-day bolus/burst of SCS), and/or an emergency room (ER) or urgent care visit requiring SCS, and/or inpatient hospitalisation, both due to asthma.
Measured: Week 28 and Week 52
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
The proportion (expressed as a percentage) 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 is presented.
Measured: Week 28 and Week 52
Secondary outcomes (14)
Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52
The AAER over Week 28 and over Week 52 is presented. The AAER was calculated as the total number of asthma exacerbations over the period (Week 28/52) divided by the total time at risk for the period (Week 28 or Week 52).
Measured: Week 28 and Week 52
Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks
The AAER for exacerbations associated with hospitalisation or ER visit over 28 weeks and over 52 weeks is presented. The AAER was calculated as the total number of asthma exacerbations over the period (Week 28/52) divided by the total time at risk for the period (Week 28 or Week 52).
Measured: Week 28 and Week 52
Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks
The AAER for exacerbations associated with hospitalisation over 28 weeks and over 52 weeks are presented. The AAER was calculated as the total number of asthma exacerbations over the period (Week 28/52) divided by the total time at risk for the period (Week 28 or Week 52).
Measured: Week 28 and Week 52
Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks
The proportion (expressed as a percentage) of participants who completed 28 or 52 weeks of treatment and did not experience an exacerbation over 28 weeks and over 52 weeks is presented.
Measured: Week 28 and Week 52
Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks
The proportion (expressed as a percentage) of participants who completed 28 or 52 weeks of treatment and did not experience an exacerbation associated with hospitalisation or ER visit over 28 weeks and over 52 weeks is presented.
Measured: Week 28 and Week 52
Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks
The proportion (expressed as a percentage) of participants who completed 28 or 52 weeks of treatment and did not experience an exacerbation associated with hospitalisation over 28 weeks and over 52 weeks is presented.
Measured: Week 28 and Week 52
Proportion of the Participants With ≥50% Reduction From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
The proportion (expressed as a percentage) of participants with ≥50% reduction from baseline in daily maintenance OCS dose at Week 28 and Week 52 is presented.
The baseline OCS dose is the prescribed OCS dose prior to first dose of investigational product (IP). The final daily OCS dose was defined as the last dose reported by participants with asthma stability verified (no change in OCS dose for at least 2 consecutive weeks).
Measured: Week 28 and Week 52
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
The categorised percent reduction from baseline in the daily maintenance OCS dose (categories: ≥90% to ≤100% reduction, ≥75% to <90% reduction, ≥50% to <75% reduction, >0% to <50% reduction, no change or any increase) at Week 28 and Week 52 is presented.
The baseline OCS dose is the prescribed OCS dose prior to first dose of IP. The final daily OCS dose was defined as the last dose reported by participants with asthma stability verified (no change in OCS dose for at least 2 consecutive weeks).
Measured: Week 28 and Week 52
Absolute Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
The absolute change from baseline in daily maintenance OCS dose at Week 28 and Week 52 is presented.
The baseline OCS dose is the prescribed OCS dose prior to first dose of IP. The final daily OCS dose was defined as the last dose reported by participants with asthma stability verified (no change in OCS dose for at least 2 consecutive weeks).
Measured: Week 28 and Week 52
Percent Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
The percent change from baseline in daily maintenance OCS dose at Week 28 and Week 52 is presented.
The baseline OCS dose is the prescribed OCS dose prior to first dose of IP. The final daily OCS dose was defined as the last dose reported by participants with asthma stability verified (no change in OCS dose for at least 2 consecutive weeks).
Measured: Week 28 and Week 52
Change From Baseline in Post-bronchodilator FEV1 at Week 28 and Week 52
The change from baseline in post-bronchodilator FEV1 at Week 28 and Week 52 is presented. Baseline was defined as the last measurement at or prior first dose of IP.
FEV1 = forced expiratory volume in 1 second
Measured: Week 28 and Week 52
Change From Baseline in ACQ-6 at Week 28 and Week 52
The Asthma Control Questionnaire 6 (ACQ-6) is a 6-item questionnaire which includes the following questions: 1) Awakening at night by symptoms, 2) Limitations of normal daily activities, 3) Waking in the morning with symptoms, 4) Dyspnoea, 5) Wheeze, and 6) Daily rescue medication. Questions were scored from 0 (totally controlled) to 6 (severely uncontrolled) and the ACQ-6 score was computed as the unweighted mean of the responses to the 6 questions. Higher scores indicate poorer outcomes.
The change from baseline in ACQ-6 at Week 28 and Week 52 is presented.
Measured: Week 28 and Week 52
Change From Baseline in Standardised AQLQ(s)+12 Total Score at Week 28 and Week 52
The Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ[S]+12) is a questionnaire that measures the health-related quality of life experienced by asthma participants. Questions were scored from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean response to all questions. Higher scores indicate better outcomes.
The change from baseline in standardised AQLQ(S)+12 total score at Week 28 and Week 52 is presented.
Measured: Week 28 and Week 52
Change From Baseline in SGRQ Total Score at Week 28 and Week 52
The St. George's Respiratory Questionnaire (SGRQ) is a 50-item instrument developed to measure the health status of participants with airway obstruction diseases. The total score indicates the impact of disease on overall health status. The total score ranges for the SGRQ are 0-100, with higher scores indicating worse health status.
The change from baseline in SGRQ total score at Week 28 and Week 52 is presented.
Measured: Week 28 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start17 May 2022
- Primary completion9 Sep 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274815
- Sponsor's protocol ID
- D5180C00037
- Other IDs
- 2021-005457-85
- Acronym
- WAYFINDER
- Status last verified
- Nov 2025
- First submitted
- 27 Jan 2022
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Jackson DJ, Lugogo NL, Gurnell M, Heaney LG, Korn S, Brusselle G, Chanez P, Del Olmo R, Llanos JP, Keeling N, Salapa K, Cook B, Parulekar AD, Kostikas K, Fogel R, Martin N, Chandarana SN. Oral corticosteroid reduction and discontinuation in adults with corticosteroid-dependent, severe, uncontrolled asthma treated with tezepelumab (WAYFINDER): a multicentre, single-arm, phase 3b trial. Lancet Respir Med. 2026 Feb;14(2):129-140. doi: 10.1016/S2213-2600(25)00359-5. Epub 2025 Nov 26.
PubMed 41317738
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Single-arm, Phase 3b Efficacy and Safety Study of Tezepelumab 210 mg Administered Subcutaneously to Reduce Oral Corticosteroid Use in Adult Participants With Severe Asthma on High-dose Inhaled Corticosteroid Plus Long-acting β2 Agonist and Long-term Oral Corticosteroid Therapy (WAYFINDER)
- ClinicalTrials.gov ID
- NCT05274815
- Acronym / sponsor ID
- WAYFINDER / D5180C00037
- Conditions
- Asthma
- Keywords
- Asthma, Severe Asthma, Oral Corticosteroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 17 May 2022 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Posted 11 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicentre, single-arm, phase 3b study designed to evaluate efficacy and safety of reducing daily oral corticosteroid use after initiation of 210 mg dose of Tezepelumab administered subcutaneously in patients with severe asthma receiving high-dose inhaled corticosteroid plus long-acting β2 agonist and oral corticosteroids with or without additional asthma controller medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label
| Arm | Type | Receives |
|---|---|---|
| Tezepelumab | Experimental | Biological: TezepelumabTezepelumab subcutaneous injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezepelumabTezepelumab subcutaneous injection | Biological | Tezepelumab |
Primary outcome
Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52
Time frame: Week 28 and Week 52
The proportion (expressed as a percentage) of participants who discontinued OCS without loss of asthma control is presented. Loss of asthma control was defined as asthma worsening or exacerbation. Asthma worsening was defined by an increase of Asthma Control Questionnaire 6 (ACQ-6) score ≥0.5 from baseline. Asthma exacerbation was defined by worsening of asthma symptoms that led to temporary bolus/burst of systemic corticosteroids (SCS; or a temporary increase in stable OCS background dose) for at least 3 consecutive days (a single depo-injectable dose of corticosteroids being considered equivalent to a 3-day bolus/burst of SCS), and/or an emergency room (ER) or urgent care visit requiring SCS, and/or inpatient hospitalisation, both due to asthma.
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
Time frame: Week 28 and Week 52
The proportion (expressed as a percentage) 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 is presented.
14 secondary outcomes
Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52
Time frame: Week 28 and Week 52
Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks
Time frame: Week 28 and Week 52
Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks
Time frame: Week 28 and Week 52
Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks
Time frame: Week 28 and Week 52
Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks
Time frame: Week 28 and Week 52
Proportion of the Participants Who Did Not Experience an Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks
Time frame: Week 28 and Week 52
Proportion of the Participants With ≥50% Reduction From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Time frame: Week 28 and Week 52
Categorised Percent Reduction From Baseline in the Daily Maintenance OCS Dose at Week 28 and Week 52
Time frame: Week 28 and Week 52
Absolute Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Time frame: Week 28 and Week 52
Percent Change From Baseline in Daily Maintenance OCS Dose at Week 28 and Week 52
Time frame: Week 28 and Week 52
Change From Baseline in Post-bronchodilator FEV1 at Week 28 and Week 52
Time frame: Week 28 and Week 52
Change From Baseline in ACQ-6 at Week 28 and Week 52
Time frame: Week 28 and Week 52
Change From Baseline in Standardised AQLQ(s)+12 Total Score at Week 28 and Week 52
Time frame: Week 28 and Week 52
Change From Baseline in SGRQ Total Score at Week 28 and Week 52
Time frame: Week 28 and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41317738Jackson DJ, Lugogo NL, Gurnell M, Heaney LG, Korn S, Brusselle G, Chanez P, Del Olmo R, Llanos JP, Keeling N, Salapa K, Cook B, Parulekar AD, Kostikas K, Fogel R, Martin N, Chandarana SN. Oral corticosteroid reduction and discontinuation in adults with corticosteroid-dependent, severe, uncontrolled asthma treated with tezepelumab (WAYFINDER): a multicentre, single-arm, phase 3b trial. Lancet Respir Med. 2026 Feb;14(2):129-140. doi: 10.1016/S2213-2600(25)00359-5. Epub 2025 Nov 26.
- Redacted CSPLink provided by the sponsor.
- Redacted CSR SynopsisLink provided by the sponsor.
- Redacted SAPLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
77 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tezepelumab in people with Asthma, run by AstraZeneca at 77 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in Argentina, Poland, France, United States, Latvia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of the Participants Who Discontinued OCS Without Loss of Asthma Control at Week 28 and Week 52 (time frame: Week 28 and Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274815, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025; AzTrials last refreshed its copy on 7 Nov 2026.