Can a drug reverse Asthma's hidden airway damage?

NCT ID NCT05651841

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether tezepelumab, an injectable drug, can reverse airway wall thickening (remodeling) in adults with asthma. Participants, aged 18 to 85 with moderate-to-severe asthma, will receive either tezepelumab or a placebo for about a year. Researchers will use CT scans to measure changes in airway structure and also study genetic activity to understand the repair process.

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 show that tezepelumab reverses structural airway damage in asthma, pointing toward a treatment that repairs rather than just manages symptoms.
What could go wrong
This is an early-stage trial with only 90 participants, so results may not apply to all asthma patients. Tezepelumab may not reverse remodeling, and side effects from the drug are possible.

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

90 people

The number who actually took part.

Started

Mar 2023

Finished

Jun 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 85 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.

Inclusion Criteria: Admitted to screening visit: * Minimum age: 18 * Maximum age: 85 * Able to perform an inspiratory and expiratory thoracic computed tomography (CT) scan, plus a nasal CT * In stable condition for CT scan * Physician-diagnosed asthma according to GINA criteria * Disease with clinical impact: at least 1 severe or 2 moderate exacerbations in the previous 12 months despite treatment according to the best standards of care * Maximal inhaled therapy comprising high dose ICS and at least a second controller according to GINA Based on results of screening visit and run-in: * Post-bronchodilator forced expiratory volume in 1 second (FEV1) predicted values must be at 25-90% * Asthma Control Questionnaire 6 (ACQ6) \> 1.5 * Oral corticosteroid maintenance therapy (if used) ≤7.5 mg/day * On CT scan, the average percentage wall area index at the B1 and B8 bronchi (generation 3, 4, 5) is \>65% Exclusion Criteria: * CT abnormalities evocative of any respiratory condition other than asthma * Treatment regimen discordant with best practices * Pulmonary disease other than asthma requiring treatment during the previous 12 months * A smoking history of \>20 pack years * Receipt of any marketed or investigational biologic agent§ within 3 months or 5 halflives (whichever is longer) prior to randomization or receipt of any investigational non biologic agent within 30 days or 5 half-lives (whichever is longest) prior to randomization or receipt of live attenuated vaccines 30 days prior to the date of randomization. Participants enrolled in current or previous tezepelumab studies will not be included. Participants on previous biologics treatment are allowed to enter the study provided the appropriate washout period is fulfilled. * Absence of signed consent * Non-beneficiary of the French social security, single-payer health insurance system * Presence of any condition (physical, psychological or other) that might, in the investigator's opinion, hinder study performance * The patient is unavailable or unwilling to participate in future visits * Potential interference from other studies * Protected populations according to the French public health code * Male or female patients seeking to conceive a child * Women of childbearing potential and fertile men not using birth control method * Pregnant, breastfeeding or lactating women * History of a clinically significant infection, including upper (URTI) or lower respiratory tract infection (LRTI), requiring treatment with antibiotics or antiviral medications finalised \< 2 weeks before randomization. Patients with preexisting serious infections should be treated before initiating therapy with tezepelumab. * 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. * Patients using vaping products, including electronic cigarettes (because may induce abnormality at CT scan). * Bronchial thermoplasty in the last 12 months prior to Visit 1. * History of documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy. * History of known immunodeficiency disorder including a positive human immunodeficiency virus test or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report. * Receipt of the T2 cytokine inhibitor Suplatast tosilate within 15 days prior to randomization. * Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), 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 randomization. * Receipt of immunoglobulin or blood products within 30 days prior to randomization. * Receipt of allergen immunotherapy not stable within 30 days prior to randomization or with anticipated change during the treatment period.

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Conditions

The condition(s) this trial relates to.

Airway Remodeling asthma

As listed by the trial registrant

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

Contacts and locations

Locations

  • APHP Bichat

    Paris, France

  • APHP Bicêtre

    Le Kremlin-Bicêtre, France

  • CHRU Strasbourg

    Strasbourg, France

  • CHU Dijon

    Dijon, France

  • CHU Grenoble Alpes La Tronche

    Grenoble, France

  • CHU Toulouse

    Toulouse, France

  • CHU de Montpelier

    Montpellier, France

  • Hôpital Foch

    Paris, France

  • Hôpital Haut-Lévêque

    Pessac, France

  • Hôpital Nord Marseille

    Marseille, France

  • Hôpital de la Croix Rousse

    Lyon, France