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New drug aims to free severe asthma patients from daily steroids

NCT ID NCT05398263

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tests whether tezepelumab, an injectable biologic, can help adults with severe asthma reduce their daily dose of oral corticosteroids while still keeping their asthma under control. Participants receive either tezepelumab or a placebo for 28 weeks, and doctors measure how much their steroid dose can be lowered. The goal is to find a safer, long-term treatment option for people who currently depend on steroids to manage their asthma.

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 it works, this could help people with severe asthma reduce or stop taking oral steroids, lowering the risk of serious side effects while maintaining asthma control.
What could go wrong
This is a relatively small Phase 3 trial, and results may not apply to all asthma patients. Tezepelumab may not reduce steroid use enough, or could cause unexpected side effects.

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

125 people

The number who actually took part.

Started

Aug 2022

Finished

Mar 2025

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: 1. Participant must be 18 to 80 years of age. 2. Documented physician-diagnosed asthma for at least 12 months prior to Visit 1. 3. Participants must have received a physician-prescribed medium- or high-dose ICS for at least 12 months prior to Visit 1. 4. Participants must have received physician prescribed LABA and high dose ICS for at least 3 months prior to Visit 1. 5. Additional maintenance asthma controller medications are allowed. The use of these medications must be documented for at least 3 months prior to Visit 1. 6. Participants must have received OCS for the treatment of asthma for at least 6 months prior to Visit 1 and on a stable dose of between ≥7.5 to ≤ 30 mg (prednisone or prednisolone) daily or daily equivalent for at least 1 month prior to Visit 1. 7. Morning pre- bronchodilator (BD) FEV1 must be \< 80% predicted normal at Visit 1 or Visit 2. 8. Evidence of asthma as documented by either: a)Post-BD responsiveness test result: FEV1 ≥12% and ≥200 mL documented either in the previous 60 months prior to or at Visit 1 or at Visit 2 or at Visit 3; OR b)Airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction \[PC20\] of \<8 mg/mL) documented in the 60 months prior to Visit 1. 9. Blood eosinophils at Visit 1 ≥150 cells/μL or documented EOS ≥300 cells/μL within 12 months prior to Visit 1. 10. Participants must have a history of at least 1 asthma exacerbation event within 24 months prior to Visit 1. 11. Participants must have received the optimised OCS dose for at least 2 weeks prior to randomisation. Other inclusion criteria per protocol apply. Main exclusion criteria 1. Any clinically important pulmonary disease other than asthma. 2. Any disorder that is not stable in the opinion of the Investigator and could: a. Affect the safety of the participant throughout the study; b. Influence the findings of the study or the interpretation; c. Impede the participant's ability to complete the entire duration of study. 3. History of cancer: a. Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1; b. Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1. 4. Asthma exacerbation, requiring use of systemic corticosteroids or increase in the maintenance dose of OCS finalized within 30 days prior to Visit 1. 5. Clinically significant infection requiring treatment with systemic antibiotics or antiviral medications finalized \< 2 weeks before Visit 1 or during the run-in period. 6. Participants with evidence of active COVID-19 infection during run-in period and optimisation. 7. A helminth 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. 8. A participant who is on SABA maintenance treatment within 30 days prior to Visit 1. 9. Current smokers or participants with smoking history ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \<10 pack years and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible. 10. 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 non-biologic agent within 30 days or 5 half-lives (whichever is longer) prior to Visit 1. 11. COVID-19 vaccination within 28 days prior to randomisation. 12. Tuberculosis requiring treatment within the 12 months prior to Visit 1. 13. During the optimisation period, asthma control reached at an OCS dose of \<7.5 mg or \>30 mg and/or 3 consecutive dose reductions after which asthma control was still obtained. Other exclusion criteria per protocol apply.

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Conditions

The condition(s) this trial relates to.

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

    Denver, Colorado, 80206, United States

  • Research Site

    Newark, Delaware, 19713, United States

  • Research Site

    Hialeah, Florida, 33016, United States

  • Research Site

    Miami Lakes, Florida, 33014, United States

  • Research Site

    Lincoln, Nebraska, 68510, United States

  • Research Site

    The Bronx, New York, 10459, United States

  • Research Site

    El Paso, Texas, 79902, United States

  • Research Site

    Kingwood, Texas, 77339, United States

  • Research Site

    Botucatu, 18618-686, Brazil

  • Research Site

    Curitiba, 80730-150, Brazil

  • Research Site

    Porto Alegre, 90035074, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Salvador, 40060-330, Brazil

  • Research Site

    São Bernardo do Campo, 09715090, Brazil

  • Research Site

    São Paulo, 01223-001, Brazil

  • Research Site

    Sorocaba, 18040-425, Brazil

  • Research Site

    Ajax, Ontario, L1S 2J5, Canada

  • Research Site

    Québec, Quebec, G1V4G5, Canada

  • Research Site

    Chile, 7770484, Chile

  • Research Site

    Curicó, 3341643, Chile

  • Research Site

    Santiago, 7500010, Chile

  • Research Site

    Santiago, 7500588, Chile

  • Research Site

    Santiago, 7500691, Chile

  • Research Site

    Santiago, 7500698, Chile

  • Research Site

    Santiago, 7750495, Chile

  • Research Site

    Santiago, 8241479, Chile

  • Research Site

    Brno, 625 00, Czechia

  • Research Site

    Hradec Králové, 500 05, Czechia

  • Research Site

    Jindřichův Hradec, 377 01, Czechia

  • Research Site

    Miroslav, 671 72, Czechia

  • Research Site

    Olomouc, 779 00, Czechia

  • Research Site

    Ostrava, 700 30, Czechia

  • Research Site

    Ajmer, 305001, India

  • Research Site

    Kanpur, 208002, India

  • Research Site

    Vadodara, 390022, India

  • Research Site

    Guadalajara, 44100, Mexico

  • Research Site

    Guadalajara, 44130, Mexico

  • Research Site

    Guadalajara, 44200, Mexico

  • Research Site

    Mexico City, 0 3100, Mexico

  • Research Site

    Monterrey, 64460, Mexico

  • Research Site

    San Luis Potosí City, 78250, Mexico

  • Research Site

    Veracruz, 91910, Mexico

  • Research Site

    Lima, 15046, Peru

  • Research Site

    Bialystok, 15-704, Poland

  • Research Site

    Bychawa, 23100, Poland

  • Research Site

    Bydgoszcz, 85-231, Poland

  • Research Site

    Chęciny, 26-060, Poland

  • Research Site

    Grudziądz, 86-300, Poland

  • Research Site

    Ostrowiec Świętokrzyski, 27-400, Poland

  • Research Site

    Poznan, 61-578, Poland

  • Research Site

    Rzeszów, 35-205, Poland

  • Research Site

    Sosnowiec, 41-208, Poland

  • Research Site

    Seoul, 05505, South Korea

  • Research Site

    Seoul, 07061, South Korea

  • Research Site

    Seoul, 143-729, South Korea

  • Research Site

    Suwon, 16499, South Korea

  • Research Site

    Bang Kra So, 11000, Thailand

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Hat Yai, 90110, Thailand

  • Research Site

    Ankara, 06620, Turkey (Türkiye)

  • Research Site

    Bursa, 16059, Turkey (Türkiye)

  • Research Site

    Istanbul, 34899, Turkey (Türkiye)

  • Research Site

    Izmir, 35040, Turkey (Türkiye)

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