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 tested for Long-Term safety in kids

NCT ID NCT03560466

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 378 children with asthma who had already taken dupilumab in an earlier trial. Researchers wanted to see if the drug is safe and tolerable over a full year. They also measured how well it controls asthma symptoms. The goal was to make sure long-term use is safe for kids.

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

378 people

The number who actually took part.

Started

Jun 2018

Finished

Apr 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

6 to 11 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 : * Pediatric patients with asthma who completed the treatment in a dupilumab asthma trial (EFC14153). * Signed written informed consent/assent. Specific for Brazil: EFC14153 patients from Brazil, who prematurely discontinued Investigational Medicinal Product (IMP) to receive Yellow Fever vaccine (a live attenuated vaccine) during Yellow Fever outbreak, are allowed to be enrolled in LTS14424 after completing the required procedures in EFC14153 (completion of remaining visits and procedures until end of treatment (EOT) V28, considered as V1 for LTS14424). Patients who are not able to complete their treatment in Study EFC14153 due to the COVID-19 pandemic will be allowed to enroll into Study LTS14424. Patients who enroll in LTS14424 after completing the EFC14153 EOS visit should have eligibility for LTS14424 reevaluated including background medication check and laboratory assessments (including complete blood count \[CBC\] with differential and basic chemistry) within 1 month prior to LTS14424 Visit 1. For Japan sub-study * Signed written inform consent/assent * Children 6 to \<12 years of age, with a physician diagnosis of persistent asthma for ≥12 months prior to screening * Blood eosinophil count ≥150 cells/μL or fractional exhaled nitric oxide (FeNO) ≥20 parts per billion (ppb) at screening visit (Visit 0). Exclusion criteria: * Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function. * Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders). * Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study. * Patients or his/her parent(s)/caregiver(s)/legal guardian(s) is related to the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff thereof directly involved in the conduct of the study. * Patients who experienced any hypersensitivity reactions to dupilumab in a previous dupilumab study, which, in the opinion of the Investigator, could indicate that continued treatment with dupilumab may present an unreasonable risk for the patient. * Any abnormalities or adverse events at screening (last treatment visit in the study EFC14153 will be the screening visit) that per Investigator judgment would adversely affect patient's participation in this study or would require permanent IMP discontinuation. * For female patients who have commenced menstruating at any time during the study and are either: * Found to have a positive urine pregnancy test, or * Sexually active, not using an established acceptable contraceptive method. * Planned live, attenuated vaccinations during the study. * Patients with active autoimmune disease or patients using immunosuppressive therapy for autoimmune disease (eg, juvenile idiopathic arthritis, inflammatory bowel disease, systemic lupus erythematosus) at enrollment. For Japan sub-study: * Any chronic lung disease other than asthma (eg, cystic fibrosis, bronchopulmonary dysplasia) which may impair lung function. * Inability to follow the procedures of the study/noncompliance (eg, due to language problems or psychological disorders). * Patients receiving concomitant treatment or required a new concomitant treatment prohibited in the study at the screening and enrollment visits. * Patients who previously have been treated with dupilumab * Diagnosed with active parasitic infection (helminthes); suspected or high risk of parasitic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before randomization * Known or suspected history of immunosuppression, including history of invasive opportunistic infections (eg, histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis), despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per Investigator's judgment. 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

  • Allergy & Asthma Research Center- Site Number : 8400003

    San Antonio, Texas, 78229, United States

  • Arizona Allergy and Immunology Research- Site Number : 8400002

    Gilbert, Arizona, 85234, United States

  • Asthma and Airway Disease Research Center Site Number : 8400012

    Tucson, Arizona, 85274, United States

  • Cincinnati Children's Hospital Medical Center Site Number : 8400008

    Cincinnati, Ohio, 45229, United States

  • Clinica de Alergia Martti Antila Site Number : 0760006

    Sorocaba, São Paulo, 18040-425, Brazil

  • Columbia University Medical Center- Site Number : 8400013

    New York, New York, 10032, United States

  • Division of Pulmonary Medicine and Allergy Medicine- Site Number : 8400006

    St Louis, Missouri, 63110-1077, United States

  • Hospital Sao Lucas da PUCRS- Site Number : 0760007

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Immunocarolina LLC Site Number : 8400004

    Charlotte, North Carolina, 28277, United States

  • Instituto da Criança of Hospital das Clínicas de São Paulo- Site Number : 0760004

    São Paulo, São Paulo, 05403-000, Brazil

  • Investigational Site Number : 0320001

    CABA, Buenos Aires, C1414AIF, Argentina

  • Investigational Site Number : 0320002

    CABA, Buenos Aires, C1122AAK, Argentina

  • Investigational Site Number : 0320003

    Buenos Aires, C1121ABE, Argentina

  • Investigational Site Number : 0320004

    Vicente Lopez, Buenos Aires F.D., B1602DQD, Argentina

  • Investigational Site Number : 0320006

    Mendoza, 5500, Argentina

  • Investigational Site Number : 0360005

    North Adelaide, South Australia, 5006, Australia

  • Investigational Site Number : 1240003

    Québec, G1V 4W2, Canada

  • Investigational Site Number : 1520001

    Valdivia, Los Ríos Region, 5090145, Chile

  • Investigational Site Number : 1520002

    Viña del Mar, Valparaiso, 2520594, Chile

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 838-0418, Chile

  • Investigational Site Number : 1520007

    Viña del Mar, Valparaiso, 2520024, Chile

  • Investigational Site Number : 1520009

    Santiago, Reg Metropolitana de Santiago, 8380453, Chile

  • Investigational Site Number : 1700002

    Cali, 760043, Colombia

  • Investigational Site Number : 1700004

    Antioquia, 050010, Colombia

  • Investigational Site Number : 3480001

    Székesfehérvár, 8000, Hungary

  • Investigational Site Number : 3480002

    Gyula, 5700, Hungary

  • Investigational Site Number : 3480003

    Töröbálint, 2045, Hungary

  • Investigational Site Number : 3480006

    Budapest, 1089, Hungary

  • Investigational Site Number : 3480007

    Zalaegerszeg, 8900, Hungary

  • Investigational Site Number : 3480008

    Szigetvár, 7900, Hungary

  • Investigational Site Number : 3480012

    Mezőkövesd, 3400, Hungary

  • Investigational Site Number : 3800003

    Florence, 50139, Italy

  • Investigational Site Number : 3800004

    Padova, 35128, Italy

  • Investigational Site Number : 3800005

    Roma, 00146, Italy

  • Investigational Site Number : 3920003

    Sapporo, Hokkaido, 064-0821, Japan

  • Investigational Site Number : 3920005

    Yotsukaido-shi, Chiba, 284-0003, Japan

  • Investigational Site Number : 3920008

    Shibukawa, Gunma, 377-8577, Japan

  • Investigational Site Number : 3920009

    Habikino-Shi, 583-0872, Japan

  • Investigational Site Number : 3920010

    Ureshino-shi, Saga-ken, 843-0393, Japan

  • Investigational Site Number : 3920011

    Fukuoka, Fukuoka, 813-0017, Japan

  • Investigational Site Number : 3920012

    Tsu, Mie-ken, 514-0125, Japan

  • Investigational Site Number : 3920013

    Chiba, Chiba, 266-0007, Japan

  • Investigational Site Number : 3920014

    Onomichi-shi, Hiroshima, 722-8508, Japan

  • Investigational Site Number : 3920015

    Fukuoka, Fukuoka, 811-1394, Japan

  • Investigational Site Number : 3920016

    Chuo-ku, Chiba, 260-0001, Japan

  • Investigational Site Number : 4400001

    Vilnius, LT-08406, Lithuania

  • Investigational Site Number : 4400003

    Utena, LT-28151, Lithuania

  • Investigational Site Number : 4400004

    Vilnius, LT-09108, Lithuania

  • Investigational Site Number : 4400005

    Šiauliai, LT-76231, Lithuania

  • Investigational Site Number : 4840001

    Monterrey, Nuevo León, 64460, Mexico

  • Investigational Site Number : 4840002

    Veracruz, 91910, Mexico

  • Investigational Site Number : 4840003

    Durango, Durango, 34080, Mexico

  • Investigational Site Number : 4840004

    Chihuahua City, 31200, Mexico

  • Investigational Site Number : 4840006

    Chihuahua City, 31000, Mexico

  • Investigational Site Number : 6160001

    Lodz, Lódzkie, 90-329, Poland

  • Investigational Site Number : 6160002

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Investigational Site Number : 6430001

    Saint Petersburg, 194100, Russia

  • Investigational Site Number : 6430002

    Saint Petersburg, 193312, Russia

  • Investigational Site Number : 6430003

    Saint Petersburg, 196158, Russia

  • Investigational Site Number : 6430004

    Perm, 614066, Russia

  • Investigational Site Number : 6430005

    Saint Petersburg, 197101, Russia

  • Investigational Site Number : 7100001

    Cape Town, 7700, South Africa

  • Investigational Site Number : 7240001

    Barcelona, Barcelona [Barcelona], 08035, Spain

  • Investigational Site Number : 7920001

    Ankara, Turkey (Türkiye)

  • Investigational Site Number : 7920003

    Istanbul, Turkey (Türkiye)

  • Investigational Site Number : 7920004

    Istanbul, Turkey (Türkiye)

  • Investigational Site Number : 7920005

    Adana, 01339, Turkey (Türkiye)

  • Investigational Site Number : 8040001

    Kyiv, 03115, Ukraine

  • Investigational Site Number : 8040002

    Zaporizhzhya, 69063, Ukraine

  • Investigational Site Number : 8040003

    Zaporizhzhya, 69076, Ukraine

  • Investigational Site Number : 8040004

    Dnipro, 49101, Ukraine

  • Investigational Site Number : 8040005

    Kharkiv, 61093, Ukraine

  • Investigational Site Number : 8040007

    Chernivtsi, 58023, Ukraine

  • Investigational Site Number : 8040008

    Kryvyi Rig, 50082, Ukraine

  • Irmandade da Santa Casa de Misericordia de Porto Alegre- Site Number : 0760001

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Northwell Health- Site Number : 8400023

    Great Neck, New York, 11021, United States

  • OK Clinical Research, LLC- Site Number : 8400024

    Edmond, Oklahoma, 73034, United States

  • Peninsula Research Associates Site Number : 8400001

    Rolling Hills Estates, California, 90274, United States

  • Rochester Regional Health- Site Number : 8400007

    Rochester, New York, 14607, United States

  • Somnos Clinical Research Site Number : 8400022

    Lincoln, Nebraska, 68505, United States

  • Unidade Ambulatorial de Pesquisa Clinica I - NGP - UNIFESP- Site Number : 0760002

    São Paulo, São Paulo, 04037-002, Brazil

More trials for these conditions

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