Could a new shot help toddlers breathe easier?

NCT ID NCT06191315

ENROLLING_BY_INVITATION Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests if dupilumab, an injected drug, can help control asthma and severe wheezing in children aged 2 to 6. About 90 kids will receive either dupilumab or a placebo for a year, with an option to continue treatment. The goal is to see if it reduces serious asthma attacks and is safe long-term.

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 provide a new treatment option to better control asthma and reduce severe wheezing attacks in young children.
What could go wrong: This is a Phase 3 trial, but results may not apply to all children. Side effects are possible, and the long-term benefits are still being studied.

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

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Conditions

The condition(s) this trial relates to.

asthma Respiratory Sounds

As listed by the trial registrant

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

ASTHMA WHEEZING

Contacts and locations

Locations

AOU Luigi Vanvitelli - Investigational Site Number : 3800004

Naples, 80131, Italy
Allergy and Asthma Specialist- Site Number : 8400002

Owensboro, Kentucky, 42301, United States
Allervie Clinical Research - Destin- Site Number : 8400016

Destin, Florida, 32541, United States
Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011

Chicago, Illinois, 60611, United States
Boston Children's Health Physicians - Hawthorne- Site Number : 8400010

Hawthorne, New York, 10532, United States
Buzzi Children's Hospital - Investigational Site Number : 3800003

Milan, Lombardy, 20154, Italy
Cincinnati Children's Hospital Medical Center- Site Number : 8400004

Cincinnati, Ohio, 45229, United States
Clinica de Alergia Martti Antila- Site Number : 0760002

Sorocaba, São Paulo, 18040-425, Brazil
EMDA Clinical Research- Site Number : 8400026

Miami, Florida, 33126, United States
Fondazione IRCCS Policlinico San Matteo - Investigational Site Number : 3800001

Pavia, 27100, Italy
Hospital Ernesto Dornelles- Site Number : 0760004

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001

São Paulo, 05403-000, Brazil
Investigational Site Number : 0320001

Buenos Aires, 1414, Argentina
Investigational Site Number : 0320002

Buenos Aires, 1122, Argentina
Investigational Site Number : 0320003

Buenos Aires, 1121, Argentina
Investigational Site Number : 0320004

Mendoza, 5500, Argentina
Investigational Site Number : 0320005

Rosario, Santa Fe Province, 2000, Argentina
Investigational Site Number : 0320006

Córdoba, 5003, Argentina
Investigational Site Number : 0320008

Buenos Aires, 1028, Argentina
Investigational Site Number : 0320009

Corrientes, 3400, Argentina
Investigational Site Number : 1240001

Vancouver, British Columbia, V6H 3N1, Canada
Investigational Site Number : 1240002

Edmonton, Alberta, T6G 2B7, Canada
Investigational Site Number : 1240005

Sherbrooke, Quebec, J1H 5N4, Canada
Investigational Site Number : 1240006

Montreal, Quebec, H3T 1C5, Canada
Investigational Site Number : 1240007

Hamilton, Ontario, L8S 1G5, Canada
Investigational Site Number : 1240008

Burlington, Ontario, L7L 6W6, Canada
Investigational Site Number : 2030001

Prague, 190 00, Czechia
Investigational Site Number : 2500001

Lille, 59000, France
Investigational Site Number : 2500002

Paris, 75019, France
Investigational Site Number : 2500003

Paris, 75571, France
Investigational Site Number : 2500004

Nice, 06200, France
Investigational Site Number : 2500005

Créteil, 94010, France
Investigational Site Number : 2760001

Leipzig, 04103, Germany
Investigational Site Number : 2760002

Düsseldorf, 40217, Germany
Investigational Site Number : 2760004

Frankfurt, 60590, Germany
Investigational Site Number : 3000001

Athens, 115 27, Greece
Investigational Site Number : 3000003

Athens, 152 36, Greece
Investigational Site Number : 3480001

Szigetvár, 7900, Hungary
Investigational Site Number : 3480002

Székesfehérvár, 8000, Hungary
Investigational Site Number : 3480004

Debrecen, 4032, Hungary
Investigational Site Number : 3480005

Budapest, 1085, Hungary
Investigational Site Number : 3800005

Padua, Padova, 35128, Italy
Investigational Site Number : 3920001

Fukuoka, 813-0017, Japan
Investigational Site Number : 3920002

Fukuoka, 811-1394, Japan
Investigational Site Number : 3920003

Ureshino, Saga-ken, 843-0393, Japan
Investigational Site Number : 3920004

Tsu, Mie-ken, 514-0125, Japan
Investigational Site Number : 3920006

Isehara, Kanagawa, 259-1193, Japan
Investigational Site Number : 4840001

San Juan del Río, Querétaro, 76800, Mexico
Investigational Site Number : 4840002

Veracruz, 91900, Mexico
Investigational Site Number : 4840004

Durango, 34000, Mexico
Investigational Site Number : 5280001

Rotterdam, 3015 CE, Netherlands
Investigational Site Number : 6160001

Lodz, Lódzkie, 93-509, Poland
Investigational Site Number : 6160003

Warsaw, Masovian Voivodeship, 02-091, Poland
Investigational Site Number : 6160004

Tarnów, Lesser Poland Voivodeship, 33-100, Poland
Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08035, Spain
Investigational Site Number : 7240002

Sabadell, Barcelona [Barcelona], 08208, Spain
Investigational Site Number : 7240003

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain
Investigational Site Number : 7240004

Valencia, 46026, Spain
Investigational Site Number : 7240005

Madrid, 28009, Spain
Investigational Site Number : 7240006

Jerez de la Frontera, Cádiz, 11407, Spain
Investigational Site Number : 7240007

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain
Investigational Site Number : 8260001

London, London, City of, SE5 9RL, United Kingdom
Investigational Site Number : 8260002

Leicester, Leicestershire, LE1 5WW, United Kingdom
Investigational Site Number : 8260003

Birmingham, England, B4 6NH, United Kingdom
Investigational Site Number : 8260004

Bradford, BD9 6RJ, United Kingdom
Mayo Clinic in Rochester - Minnesota- Site Number : 8400008

Rochester, Minnesota, 55905, United States
Ospedale Pediatrico Bambino Gesù - Investigational Site Number : 3800002

Rome, Roma, 00165, Italy
Phoenix Children's Hospital- Site Number : 8400001

Phoenix, Arizona, 85016, United States
South Texas Medical Research Institute - TTS Research- Site Number : 8400022

Boerne, Texas, 78006, United States
Texas Children's Hospital- Site Number : 8400027

Houston, Texas, 77030, United States
UBMD Pediatrics- Site Number : 8400013

Buffalo, New York, 14203, United States
UNC Children's Hospital- Site Number : 8400005

Chapel Hill, North Carolina, 27514, United States
University Hospitals Cleveland Medical Center- Site Number : 8400015

Cleveland, Ohio, 44106, United States
Vanderbilt University Medical Center- Site Number : 8400024

Nashville, Tennessee, 37232, United States

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