Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Asthma drug dupilumab targets lung mucus in new imaging study

NCT ID NCT04400318

Disease control Sponsor: Sanofi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested dupilumab (Dupixent) in 109 adults with uncontrolled moderate-to-severe asthma. Researchers used lung scans and breathing tests to see if the drug reduces airway inflammation and mucus plugging. Participants received either dupilumab or a placebo for 24 weeks. The goal was to understand how dupilumab improves lung function and asthma control.

What this could mean

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

Active substance
Dupilumab (Dupixent)
What this could lead to
If successful, this could confirm dupilumab's ability to reduce lung inflammation and mucus buildup, improving breathing and asthma control.
What could go wrong
This is a completed phase 4 study with 109 participants, so results are already in. However, benefits may not apply to all asthma types, and side effects like injection reactions or infections 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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

109 people

The number who actually took part.

Started

Jun 2020

Finished

Aug 2023

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 70 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: * 18 to 70 years of age inclusive with the diagnosis of asthma based on Global Strategy for Asthma Management and Prevention (GINA) 2019 at the time of signing the informed consent * History of ≥1 exacerbation(s) in the previous year * Uncontrolled moderate to severe asthma (ACQ-5 ≥1.5) at visit (V)1 and V2, prior to randomization * Pre-bronchodilator FEV1 ≤80% of predicted normal at V1 and V2, prior to randomization * Exhibit bronchodilator reversibility (≥12% and 200 mL improvement in FEV1 post SABA administration) during screening, prior to randomization * Blood eosinophil ≥300 cells /µL and FeNO ≥25 ppb during screening, prior to randomization NOTES: * Historical values of blood eosinophil count meeting the eligibility criterion measured within 6 months prior to SV1 in the absence of OCS treatment are allowed. * FeNO value to be checked for eligibility at V2 as well. -Existing treatment with medium to high dose ICS in combination with a second controller (e.g. LABA, LTRA) ± a third controller. The dose regimen should be stable ≥1 month prior V1 and during screening. Exclusion Criteria: * Current smoker (cigarette or e-cigarette) or cessation of smoking within 1 year prior randomization * Previous smoker with a smoking history \>10 pack-years * Known hypersensitivity to dupilumab or any of its excipients * A subject who experiences an asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due to asthma, or treatment with systemic steroids) during screening * Current acute bronchospasm or status asthmaticus * Diagnosed pulmonary (other than asthma) or systemic disease associated with elevated peripheral eosinophil counts * History or clinical evidence of chronic obstructive pulmonary disease (COPD) including Asthma-COPD Overlap Syndrome (ACOS) or any other significant lung disease (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome, etc) * Active tuberculosis, latent untreated tuberculosis or a history of incompletely treated tuberculosis or non-tuberculous mycobacterial infection unless it is well documented by a specialist that the participants has been adequately treated and the treatment with a biologic agent can be initiated, in the medical judgment of the Investigator and/or infectious disease specialist. Tuberculosis testing would only be performed on a country by country basis according to the routine clinical practice and the local guidelines, if required by regulatory authorities or ethics committees * History of or current evidence of clinically significant disease in any non-respiratory system (e.g. cardiovascular, hepatic, nervous system, gastrointestinal, endocrinological, rheumatological, dermatological), which, in the judgment of the Investigator, could interfere with the study or require treatment that might interfere with the study * Current evidence of clinically significant oncological disease, which in the opinion of the investigator may interfere with the objectives of the study or put the subject at undue risk * Participants with any of the following results at V1: * Positive (or indeterminate) hepatitis B surface antigen (HBs Ag) or * Positive Hepatitis B IgM core antibody (IgM HBc Ab) or * Positive total hepatitis B core antibody (total HBc Ab) confirmed by positive HBV DNA or * Positive hepatitis C antibody (HCV Ab) confirmed by positive HCV RNA * History of human immunodeficiency virus (HIV) infection or positive HIV serology at V1 * Any biologic therapy (including experimental treatments and dupilumab) or any other biologic therapy/immunosuppressant within 3 months prior to V1 * Treatment with live (attenuated) vaccine within 4 weeks before V1. For participants who have vaccination with live, attenuated vaccines planned during the course of the study (based on national vaccination schedule/local guidelines), it will be determined, after consultation with a physician, whether the administration of vaccine can be postponed until after the end of the study, or preponed to before the start of the study without compromising the health of the participant: * Participants for whom administration of live (attenuated) vaccine can be safely postponed would be eligible to enroll into the study. * Participants who have their vaccination preponed can enroll in the study only after a gap of 4 weeks following administration of the vaccine. * Treatment with oral corticosteroids (OCS) within 2 weeks prior to V1 * Enrolled in other ongoing studies regardless of the investigational product * Treatment with an investigational drug within 1 month or within 5 half-lives (if known), whichever is longer, prior to V1 * Suspected or high risk of parasitic infection (helminthic infection), unless clinical and (if necessary) laboratory assessments have ruled out active infection prior to randomization * Females who are lactating, breastfeeding, or who are pregnant * Individuals accommodated in an institution because of regulatory or legal order; prisoners or subjects who are legally institutionalized * Participants are dependent on the Sponsor or Investigator (in conjunction with Section 1.61 of the ICH GCP Ordinance E6) * Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Any country-related specific regulation that would prevent the subject from entering the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Asthma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Allianz Research Institute Site Number : 8400020

    Westminster, California, 92683, United States

  • American Health Research Site Number : 8400005

    Charlotte, North Carolina, 28277, United States

  • Investigational Site Number : 1000002

    Sofia, 1680, Bulgaria

  • Investigational Site Number : 1000003

    Sofia, 1233, Bulgaria

  • Investigational Site Number : 1000004

    Montana, 3403, Bulgaria

  • Investigational Site Number : 1000005

    Sofia, 1202, Bulgaria

  • Investigational Site Number : 1000006

    Sofia, 1233, Bulgaria

  • Investigational Site Number : 1000007

    Stara Zagora, 6001, Bulgaria

  • Investigational Site Number : 1000008

    Rousse, 7002, Bulgaria

  • Investigational Site Number : 1000010

    Sofia, 1431, Bulgaria

  • Investigational Site Number : 1000011

    Sofia, 1407, Bulgaria

  • Investigational Site Number : 1000012

    Plovdiv, 4002, Bulgaria

  • Investigational Site Number : 1000013

    Dupnitsa, 2600, Bulgaria

  • Investigational Site Number : 1000015

    Sofia, 1000, Bulgaria

  • Investigational Site Number : 1000018

    Plovdiv, 4000, Bulgaria

  • Investigational Site Number : 1580001

    Taipei, 110, Taiwan

  • Investigational Site Number : 1580002

    Taichung, 40447, Taiwan

  • Investigational Site Number : 1580003

    Tainan, 704, Taiwan

  • Investigational Site Number : 1580004

    Kaohsiung City, 807, Taiwan

  • Investigational Site Number : 2080001

    Hvidovre, 2650, Denmark

  • Investigational Site Number : 2080002

    Copenhagen, 2100, Denmark

  • Investigational Site Number : 2080003

    Copenhagen Nv, 2400, Denmark

  • Investigational Site Number : 2080006

    Aarhus N, 8200, Denmark

  • Investigational Site Number : 2500001

    Montpellier, France

  • Investigational Site Number : 3800001

    Pisa, 56124, Italy

  • Investigational Site Number : 3800003

    Cona, Ferrara, 44124, Italy

  • Investigational Site Number : 3800004

    Rozzano, Milano, 20089, Italy

  • Investigational Site Number : 6200001

    Porto, 4202-451, Portugal

  • Investigational Site Number : 6200003

    Porto, 4100-180, Portugal

  • Investigational Site Number : 6200004

    Coimbra, 3000-075, Portugal

  • Investigational Site Number : 6200005

    Guimarães, 4810-061, Portugal

  • Investigational Site Number : 6200006

    Lisbon, 1649-035, Portugal

  • Investigational Site Number : 6420001

    Cluj-Napoca, 400371, Romania

  • Investigational Site Number : 6420003

    Timișoara, 300134, Romania

  • Investigational Site Number : 6420005

    Bragadiru, 769764, Romania

  • Investigational Site Number : 6420006

    Cluj-Napoca, 400275, Romania

  • Investigational Site Number : 6420007

    Oradea, 410155, Romania

  • Investigational Site Number : 6420008

    Brasov, 500283, Romania

  • Investigational Site Number : 6820001

    Riyadh, 11525, Saudi Arabia

  • Investigational Site Number : 6820002

    Riyadh, 12372, Saudi Arabia

  • Investigational Site Number : 6820004

    Jeddah, 21423, Saudi Arabia

  • Investigational Site Number : 6820006

    Riyadh, 11426, Saudi Arabia

  • Investigational Site Number : 6820008

    Dammam, 31952, Saudi Arabia

  • Investigational Site Number : 6820010

    Riyadh, 12746, Saudi Arabia

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7240002

    Santiago de Compostela, Galicia [Galicia], 15706, Spain

  • Investigational Site Number : 7240003

    Madrid, Madrid, Comunidad de, 28046, Spain

  • Investigational Site Number : 7240005

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Investigational Site Number : 7520001

    Lund, 221 85, Sweden

  • Investigational Site Number : 8040001

    Ivano-Frankivsk, 76018, Ukraine

  • Investigational Site Number : 8040002

    Kharkiv, 61124, Ukraine

  • Investigational Site Number : 8040003

    Chernivtsi, 58001, Ukraine

  • Investigational Site Number : 8040004

    Kyiv, 01023, Ukraine

  • Investigational Site Number : 8040005

    Odesa, 65025, Ukraine

  • Investigational Site Number : 8040007

    Ternopil, 46000, Ukraine

  • Investigational Site Number : 8260001

    Leicester, Leicestershire, LE3 9QP, United Kingdom

  • Investigational Site Number : 8260002

    Bradford, BD9 6RJ, United Kingdom

  • Medical University of South Carolina - Pulmonary & Critical Care Clinical Research Program Site Number : 8400009

    Charleston, South Carolina, 29425, United States

  • The Lung Research Center Site Number : 8400010

    Chesterfield, Missouri, 63017, United States

  • University of Kansas School of Medicine Site Number : 8400008

    Kansas City, Kansas, 66103, United States

  • University of Michigan Site Number : 8400002

    Ann Arbor, Michigan, 48109, United States

  • Velocity Clinical Research, Medford Site Number : 8400014

    Medford, Oregon, 97504, United States

  • VitaLink Research - Spartanburg Site Number : 8400011

    Spartanburg, South Carolina, 29303, United States

  • VitaLink Research-Greenville Site Number : 8400013

    Greenville, South Carolina, 29615, United States

  • ~Spartanburg Medical Research Site Number : 8400004

    Spartanburg, South Carolina, 29303, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.