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ENROLLING BY INVITATION

NCT06191315

PHASE3

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Sponsor: Sanofi

View on ClinicalTrials.gov

Summary

This is a parallel, Phase 3, 2-arm study to evaluate the efficacy and long-term safety of dupilumab treatment in children 2 to \<6 years of age with uncontrolled asthma and/or recurrent severe asthmatic wheeze. The study will be conducted in 2 parts. Part A will be a 52-week, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of dupilumab in children aged 2 to \<6 years old with uncontrolled asthma and/or recurrent severe asthmatic wheeze. At the end of Part A, all eligible participants will be offered participation in Part B, an optional open-label extension phase. Study details include: Part A: The study duration of part A will be up to 68 weeks consisting of a 4-week Screening, a 52week treatment period, and a 12-week post-treatment follow-up period. For participants who will chose to participate in Part B, the study duration will be up to 120 weeks (additional 52-week treatment period). Part B: For participants who will choose to participate in Part B, the study duration will be up to 120 weeks (Part A \[4-week Screening and a 52-week treatment period\] plus additional 52-week treatment period and a 12-week post-treatment follow-up period).

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze

Key Details

Gender

All

Age Range

2 Years - 5 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-01-03

Completion Date

2028-12-21

Last Updated

2026-08-13

Healthy Volunteers

Conditions

Wheezing Asthma

Interventions

DRUG

Dupilumab

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

DRUG

Placebo

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Inclusion Criteria: * Participant must be 2 to \<6 years of age * Diagnosis of asthma or recurrent severe asthmatic wheeze that is not controlled with chronic ICS for at least 3 months with stable use of at least low dose ICS for ≥1 month prior to Screening Visit 1 with evidence of uncontrolled asthma and/or recurrent severe asthmatic wheeze. * At least one additional major criterion from the modified asthma predictive index: 1. Physician diagnosed Atopic Dermatitis, 2. Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L). OR 2 minor criteria: 3. Wheezing unrelated to colds, 4. Peripheral blood eosinophilia ≥4%, 5. Allergic sensitization to milk, eggs, or peanuts (defined by serum specific IgE \>0.35 kU/L. * Parent(s)/caregiver(s)/legal guardian(s) willing and able to comply with clinic visits and study-related procedures. * Parent(s)/caregiver(s)/legal guardian(s) able to understand the study requirements. * Participants/parent(s)/caregiver(s)/legal guardian(s), as appropriate, must be able to understand and complete study-related questionnaires * Body weight at screening and randomization \>5 kg and \<30 kg. * Parents or caregivers or legal guardian capable of giving signed informed consent. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Severe asthma with the need for chronic oral/systemic corticosteroid use (\>1 month continuous) at the time of screening enrollment. * History of a systemic hypersensitivity reaction or anaphylaxis to biologic therapy, including any excipient. * History of prematurity (\<34 weeks gestation). * Any other chronic lung disease that would impair lung function (eg, cystic fibrosis, bronchopulmonary dysplasia) or chronic lung disease of prematurity or need for oxygen for more than 5 days in the neonatal period. * History of life-threatening asthma (eg, requiring intubation). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (74)

Phoenix Children's Hospital- Site Number : 8400001

Phoenix, Arizona, United States

Allervie Clinical Research - Destin- Site Number : 8400016

Destin, Florida, United States

EMDA Clinical Research- Site Number : 8400026

Miami, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011

Chicago, Illinois, United States

Allergy and Asthma Specialist- Site Number : 8400002

Owensboro, Kentucky, United States

Mayo Clinic in Rochester - Minnesota- Site Number : 8400008

Rochester, Minnesota, United States

UBMD Pediatrics- Site Number : 8400013

Buffalo, New York, United States

Boston Children's Health Physicians - Hawthorne- Site Number : 8400010

Hawthorne, New York, United States

UNC Children's Hospital- Site Number : 8400005

Chapel Hill, North Carolina, United States

Cincinnati Children's Hospital Medical Center- Site Number : 8400004

Cincinnati, Ohio, United States

University Hospitals Cleveland Medical Center- Site Number : 8400015

Cleveland, Ohio, United States

Vanderbilt University Medical Center- Site Number : 8400024

Nashville, Tennessee, United States

South Texas Medical Research Institute - TTS Research- Site Number : 8400022

Boerne, Texas, United States

Texas Children's Hospital- Site Number : 8400027

Houston, Texas, United States

Investigational Site Number : 0320005

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320008

Buenos Aires, Argentina

Investigational Site Number : 0320003

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320009

Corrientes, Argentina

Investigational Site Number : 0320006

Córdoba, Argentina

Investigational Site Number : 0320004

Mendoza, Argentina

Hospital Ernesto Dornelles- Site Number : 0760004

Porto Alegre, Rio Grande do Sul, Brazil

Clinica de Alergia Martti Antila- Site Number : 0760002

Sorocaba, São Paulo, Brazil

Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760001

São Paulo, Brazil

Investigational Site Number : 1240002

Edmonton, Alberta, Canada

Investigational Site Number : 1240001

Vancouver, British Columbia, Canada

Investigational Site Number : 1240008

Burlington, Ontario, Canada

Investigational Site Number : 1240007

Hamilton, Ontario, Canada

Investigational Site Number : 1240006

Montreal, Quebec, Canada

Investigational Site Number : 1240005

Sherbrooke, Quebec, Canada

Investigational Site Number : 2030001

Prague, Czechia

Investigational Site Number : 2500005

Créteil, France

Investigational Site Number : 2500001

Lille, France

Investigational Site Number : 2500004

Nice, France

Investigational Site Number : 2500002

Paris, France

Investigational Site Number : 2500003

Paris, France

Investigational Site Number : 2760002

Düsseldorf, Germany

Investigational Site Number : 2760004

Frankfurt, Germany

Investigational Site Number : 2760001

Leipzig, Germany

Investigational Site Number : 3000001

Athens, Greece

Investigational Site Number : 3000003

Athens, Greece

Investigational Site Number : 3480005

Budapest, Hungary

Investigational Site Number : 3480004

Debrecen, Hungary

Investigational Site Number : 3480002

Székesfehérvár, Hungary

Investigational Site Number : 3480001

Szigetvár, Hungary

Buzzi Children's Hospital - Investigational Site Number : 3800003

Milan, Lombardy, Italy

Investigational Site Number : 3800005

Padua, Padova, Italy

Ospedale Pediatrico Bambino Gesù - Investigational Site Number : 3800002

Rome, Roma, Italy

AOU Luigi Vanvitelli - Investigational Site Number : 3800004

Naples, Italy

Fondazione IRCCS Policlinico San Matteo - Investigational Site Number : 3800001

Pavia, Italy

Investigational Site Number : 3920006

Isehara, Kanagawa, Japan

Investigational Site Number : 3920004

Tsu, Mie-ken, Japan

Investigational Site Number : 3920003

Ureshino, Saga-ken, Japan

Investigational Site Number : 3920002

Fukuoka, Japan

Investigational Site Number : 3920001

Fukuoka, Japan

Investigational Site Number : 4840001

San Juan del Río, Querétaro, Mexico

Investigational Site Number : 4840004

Durango, Mexico

Investigational Site Number : 4840002

Veracruz, Mexico

Investigational Site Number : 5280001

Rotterdam, Netherlands

Investigational Site Number : 6160004

Tarnów, Lesser Poland Voivodeship, Poland

Investigational Site Number : 6160001

Lodz, Lódzkie, Poland

Investigational Site Number : 6160003

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 7240003

Santiago de Compostela, A Coruña [La Coruña], Spain

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number : 7240007

Esplugues de Llobregat, Barcelona [Barcelona], Spain

Investigational Site Number : 7240002

Sabadell, Barcelona [Barcelona], Spain

Investigational Site Number : 7240006

Jerez de la Frontera, Cádiz, Spain

Investigational Site Number : 7240005

Madrid, Spain

Investigational Site Number : 7240004

Valencia, Spain

Investigational Site Number : 8260003

Birmingham, England, United Kingdom

Investigational Site Number : 8260002

Leicester, Leicestershire, United Kingdom

Investigational Site Number : 8260001

London, London, City of, United Kingdom

Investigational Site Number : 8260004

Bradford, United Kingdom

Clinical Research Directory

Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (74)