Study to Evaluate Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adult Patients With Severe Asthma

NCT05274815 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: D5180C000372021-005457-85
• Study Type: interventional
• Target: 305
• Locations: 11 countries
• Sites: 77

Brief 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.

Conditions

Asthma

Keywords

Asthma; Severe Asthma; Oral Corticosteroids

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Week 28 and Week 52

Secondary Outcomes (14)

• Annual Asthma Exacerbation Rate (AAER) Over Week 28 and Over Week 52

  Week 28 and Week 52

• Rate of Asthma Exacerbation Associated With Hospitalisation or ER Visit Over 28 Weeks and Over 52 Weeks

  Week 28 and Week 52

• Rate of Asthma Exacerbation Associated With Hospitalisation Over 28 Weeks and Over 52 Weeks

  Week 28 and Week 52

• Proportion of the Participants Who Did Not Experience an Exacerbation Over 28 Weeks and Over 52 Weeks

  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

  Week 28 and Week 52

Study Arms (1)

Tezepelumab

EXPERIMENTAL

Tezepelumab subcutaneous injection

Biological: Tezepelumab

Interventions

Tezepelumab BIOLOGICAL

Tezepelumab subcutaneous injection

Tezepelumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (77)

Research Site

Newport Beach, California, 92663, United States

Location

Research Site

Newark, Delaware, 19713, United States

Location

Research Site

Loxahatchee Groves, Florida, 33470, United States

Location

Research Site

Ann Arbor, Michigan, 48109, United States

Location

Research Site

Toms River, New Jersey, 08755, United States

Location

Research Site

The Bronx, New York, 10467, United States

Location

Research Site

DuBois, Pennsylvania, 15801, United States

Location

Research Site

Buenos Aires, C1121ABE, Argentina

Location

Research Site

CABA, 1426, Argentina

Location

Research Site

CABA, C1012AAR, Argentina

Location

Research Site

Mendoza, M5500GHB, Argentina

Location

Research Site

Monte Grande, 1842, Argentina

Location

Research Site

Pilar, 1629, Argentina

Location

Research Site

Quilmes, B1878FNR, Argentina

Location

Research Site

Ranelagh, 1886, Argentina

Location

Research Site

Rosario, 2000, Argentina

Location

Research Site

San Fernando, B1646EBJ, Argentina

Location

Research Site

San Juan Bautista, 1888, Argentina

Location

Research Site

San Miguel de Tucumán, 4000, Argentina

Location

Research Site

Brussels (Woluwé-St-Lambert), 1200, Belgium

Location

Research Site

Erpent, 5101, Belgium

Location

Research Site

Ghent, 9000, Belgium

Location

Research Site

Liège, 4000, Belgium

Location

Research Site

Haskovo, 6305, Bulgaria

Location

Research Site

Razgrad, 7200, Bulgaria

Location

Research Site

Sofia, 1142, Bulgaria

Location

Research Site

Sofia, 1431, Bulgaria

Location

Research Site

Sofia, 5000, Bulgaria

Location

Research Site

Velika Tarnovo, 5250, Bulgaria

Location

Research Site

Antony, 92160, France

Location

Research Site

Bordeaux, 33076, France

Location

Research Site

Brest, 29609, France

Location

Research Site

Lyon, 69004, France

Location

Research Site

Marseille, 13915, France

Location

Research Site

Montpellier, France

Location

Research Site

Nantes, 44000, France

Location

Research Site

Nice, 06000, France

Location

Research Site

Berlin, 12203, Germany

Location

Research Site

Darmstadt, 64283, Germany

Location

Research Site

Fürstenwalde, 15517, Germany

Location

Research Site

Mainz, 55128, Germany

Location

Research Site

Reinfeld (Holstein), 23858, Germany

Location

Research Site

Daugavpils, LV-5410, Latvia

Location

Research Site

Daugavpils, LV-5417, Latvia

Location

Research Site

Jūrmala, LV-2015, Latvia

Location

Research Site

Riga, LV-1011, Latvia

Location

Research Site

Riga, LV1002, Latvia

Location

Research Site

Riga, LV1010, Latvia

Location

Research Site

Valmiera, LV-4201, Latvia

Location

Research Site

Chihuahua City, 31000, Mexico

Location

Research Site

Chihuahua City, 31200, Mexico

Location

Research Site

Guadalajara, 44100, Mexico

Location

Research Site

Monterrey, 64360, Mexico

Location

Research Site

Bychawa, 23100, Poland

Location

Research Site

Chmielnik, 26-020, Poland

Location

Research Site

Gdansk, 80-952, Poland

Location

Research Site

Krakow, 31-011, Poland

Location

Research Site

Lodz, 92-213, Poland

Location

Research Site

Ostrowiec Świętokrzyski, 27-400, Poland

Location

Research Site

Sosnowiec, 41-200, Poland

Location

Research Site

Wroclaw, 50-044, Poland

Location

Research Site

Wroclaw, 53-301, Poland

Location

Research Site

Wroclaw, 54-239, Poland

Location

Research Site

Badalona, 08916, Spain

Location

Research Site

Barcelona, 8035, Spain

Location

Research Site

Madrid, 28041, Spain

Location

Research Site

Oviedo, 33011, Spain

Location

Research Site

Santa Cruz de Tenerife, 38010, Spain

Location

Research Site

Santander, 39008, Spain

Location

Research Site

Seville, 41009, Spain

Location

Research Site

Belfast, BT97AB, United Kingdom

Location

Research Site

Bradford, BD9 6RJ, United Kingdom

Location

Research Site

LE3 9QP, United Kingdom

Location

Research Site

London, SE1 7EH, United Kingdom

Location

Research Site

London, SW3 6HP, United Kingdom

Location

Research Site

Nottingham, NG5 1PB, United Kingdom

Location

Research Site

Portsmouth, PO6 3LY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41317738 DERIVED

Related Links

• Redacted CSP
• Redacted CSR Synopsis
• Redacted SAP

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

8772409479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: March 10, 2022
• Study Start: May 17, 2022
• Primary Completion: September 9, 2024
• Study Completion: September 9, 2024
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of the timelines, please rerefer to the disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

AR (12); GB (7); ES (7); PL (10); DE (5); FR (8); US (7); BU (6); ME (4); BE (4); LA (7)