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New asthma drug could let patients ditch daily steroid pills

NCT ID NCT05274815

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called tezepelumab in 305 adults with severe asthma who were already taking daily steroid pills. The goal was to see if tezepelumab could help them safely reduce or stop their oral steroids without losing asthma control. Participants received tezepelumab injections every 4 weeks, and researchers tracked how many could lower their steroid dose over 28 and 52 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tezepelumab
What this could lead to
If successful, this could offer a way for people with severe asthma to reduce or stop taking daily oral steroids, lowering the risk of steroid side effects.
What could go wrong
This is a single-arm study without a placebo group, so results may be less reliable. It also focuses on steroid reduction, not a cure, and long-term safety is still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

305 people

The number who actually took part.

Started

May 2022

Finished

Sep 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Research Site

    Newport Beach, California, 92663, United States

  • Research Site

    Newark, Delaware, 19713, United States

  • Research Site

    Loxahatchee Groves, Florida, 33470, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Toms River, New Jersey, 08755, United States

  • Research Site

    The Bronx, New York, 10467, United States

  • Research Site

    DuBois, Pennsylvania, 15801, United States

  • Research Site

    Buenos Aires, C1121ABE, Argentina

  • Research Site

    CABA, 1426, Argentina

  • Research Site

    CABA, C1012AAR, Argentina

  • Research Site

    Mendoza, M5500GHB, Argentina

  • Research Site

    Monte Grande, 1842, Argentina

  • Research Site

    Pilar, 1629, Argentina

  • Research Site

    Quilmes, B1878FNR, Argentina

  • Research Site

    Ranelagh, 1886, Argentina

  • Research Site

    Rosario, 2000, Argentina

  • Research Site

    San Fernando, B1646EBJ, Argentina

  • Research Site

    San Juan Bautista, 1888, Argentina

  • Research Site

    San Miguel de Tucumán, 4000, Argentina

  • Research Site

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

  • Research Site

    Erpent, 5101, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Haskovo, 6305, Bulgaria

  • Research Site

    Razgrad, 7200, Bulgaria

  • Research Site

    Sofia, 1142, Bulgaria

  • Research Site

    Sofia, 1431, Bulgaria

  • Research Site

    Sofia, 5000, Bulgaria

  • Research Site

    Velika Tarnovo, 5250, Bulgaria

  • Research Site

    Antony, 92160, France

  • Research Site

    Bordeaux, 33076, France

  • Research Site

    Brest, 29609, France

  • Research Site

    Lyon, 69004, France

  • Research Site

    Marseille, 13915, France

  • Research Site

    Montpellier, France

  • Research Site

    Nantes, 44000, France

  • Research Site

    Nice, 06000, France

  • Research Site

    Berlin, 12203, Germany

  • Research Site

    Darmstadt, 64283, Germany

  • Research Site

    Fürstenwalde, 15517, Germany

  • Research Site

    Mainz, 55128, Germany

  • Research Site

    Reinfeld (Holstein), 23858, Germany

  • Research Site

    Daugavpils, LV-5410, Latvia

  • Research Site

    Daugavpils, LV-5417, Latvia

  • Research Site

    Jūrmala, LV-2015, Latvia

  • Research Site

    Riga, LV-1011, Latvia

  • Research Site

    Riga, LV1002, Latvia

  • Research Site

    Riga, LV1010, Latvia

  • Research Site

    Valmiera, LV-4201, Latvia

  • Research Site

    Chihuahua City, 31000, Mexico

  • Research Site

    Chihuahua City, 31200, Mexico

  • Research Site

    Guadalajara, 44100, Mexico

  • Research Site

    Monterrey, 64360, Mexico

  • Research Site

    Bychawa, 23100, Poland

  • Research Site

    Chmielnik, 26-020, Poland

  • Research Site

    Gdansk, 80-952, Poland

  • Research Site

    Krakow, 31-011, Poland

  • Research Site

    Lodz, 92-213, Poland

  • Research Site

    Ostrowiec Świętokrzyski, 27-400, Poland

  • Research Site

    Sosnowiec, 41-200, Poland

  • Research Site

    Wroclaw, 50-044, Poland

  • Research Site

    Wroclaw, 53-301, Poland

  • Research Site

    Wroclaw, 54-239, Poland

  • Research Site

    Badalona, 08916, Spain

  • Research Site

    Barcelona, 8035, Spain

  • Research Site

    Madrid, 28041, Spain

  • Research Site

    Oviedo, 33011, Spain

  • Research Site

    Santa Cruz de Tenerife, 38010, Spain

  • Research Site

    Santander, 39008, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Belfast, BT97AB, United Kingdom

  • Research Site

    Bradford, BD9 6RJ, United Kingdom

  • Research Site

    LE3 9QP, United Kingdom

  • Research Site

    London, SE1 7EH, United Kingdom

  • Research Site

    London, SW3 6HP, United Kingdom

  • Research Site

    Nottingham, NG5 1PB, United Kingdom

  • Research Site

    Portsmouth, PO6 3LY, United Kingdom

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