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

NCT06191315 | Recruiting Phase 3 FDA Drug

• 3 other identifiers: EFC147712023-504331-41U1111-1246-7432
• Study Type: interventional
• Target: 90
• Locations: 16 countries
• Sites: 74

Brief 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).

Conditions

Wheezing; Asthma

Outcome Measures

Primary Outcomes (2)

• Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period

  Annualized rate of severe asthma exacerbations during the 52-week treatment period.

  Baseline through Week 52

• Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation

  Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.

  Week 52 through Week 116

Secondary Outcomes (21)

• Part A: Annualized rate of hospitalization, ER or urgent care visit for asthma exacerbation during the 52week treatment period.

  Baseline through Week 52

• Part A: Annualized rate of moderate asthma exacerbations during the 52-week treatment period

  Baseline through Week 52

• Part A: Cumulative ICS dose during the 52-week treatment period

  Baseline through Week 52

• Part A: Change from baseline in weekly average use of reliever medication during the 52-week treatment period

  Baseline to Week 52

• Part A: Mean number of days without asthma symptoms (DWAS) using the Pediatric Asthma Caregiver Diary (PACD) during the 52-week treatment period

  Baseline through Week 52

Study Arms (2)

Dupilumab (double-blind period)

EXPERIMENTAL

Dupilumab subcutaneous injection as per protocol

Drug: Dupilumab

Placebo

PLACEBO COMPARATOR

Placebo matching dupilumab subcutaneous injection as per protocol

Drug: Placebo

Interventions

Dupilumab DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Also known as: SAR231893, Dupixent

Dupilumab (double-blind period)

Placebo DRUG

Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Placebo

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:
• Physician diagnosed Atopic Dermatitis,
• Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L).
• OR 2 minor criteria:
• Wheezing unrelated to colds,
• Peripheral blood eosinophilia ≥4%,
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (74)

Phoenix Children's Hospital- Site Number : 8400001

Phoenix, Arizona, 85016, United States

RECRUITING

Allervie Clinical Research - Destin- Site Number : 8400016

Destin, Florida, 32541, United States

RECRUITING

EMDA Clinical Research- Site Number : 8400026

Miami, Florida, 33126, United States

RECRUITING

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

Chicago, Illinois, 60611, United States

RECRUITING

Allergy and Asthma Specialist- Site Number : 8400002

Owensboro, Kentucky, 42301, United States

RECRUITING

Mayo Clinic in Rochester - Minnesota- Site Number : 8400008

Rochester, Minnesota, 55905, United States

RECRUITING

UBMD Pediatrics- Site Number : 8400013

Buffalo, New York, 14203, United States

RECRUITING

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

Hawthorne, New York, 10532, United States

RECRUITING

UNC Children's Hospital- Site Number : 8400005

Chapel Hill, North Carolina, 27514, United States

RECRUITING

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

Cincinnati, Ohio, 45229, United States

RECRUITING

University Hospitals Cleveland Medical Center- Site Number : 8400015

Cleveland, Ohio, 44106, United States

RECRUITING

Vanderbilt University Medical Center- Site Number : 8400024

Nashville, Tennessee, 37232, United States

RECRUITING

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

Boerne, Texas, 78006, United States

RECRUITING

Texas Children's Hospital- Site Number : 8400027

Houston, Texas, 77030, United States

RECRUITING

Investigational Site Number : 0320005

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Investigational Site Number : 0320008

Buenos Aires, 1028, Argentina

RECRUITING

Investigational Site Number : 0320003

Buenos Aires, 1121, Argentina

RECRUITING

Investigational Site Number : 0320002

Buenos Aires, 1122, Argentina

RECRUITING

Investigational Site Number : 0320001

Buenos Aires, 1414, Argentina

RECRUITING

Investigational Site Number : 0320009

Corrientes, 3400, Argentina

RECRUITING

Investigational Site Number : 0320006

Córdoba, 5003, Argentina

RECRUITING

Investigational Site Number : 0320004

Mendoza, 5500, Argentina

RECRUITING

Hospital Ernesto Dornelles- Site Number : 0760004

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

ACTIVE NOT RECRUITING

Clinica de Alergia Martti Antila- Site Number : 0760002

Sorocaba, São Paulo, 18040-425, Brazil

ACTIVE NOT RECRUITING

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

São Paulo, 05403-000, Brazil

ACTIVE NOT RECRUITING

Investigational Site Number : 1240002

Edmonton, Alberta, T6G 2B7, Canada

RECRUITING

Investigational Site Number : 1240001

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

Investigational Site Number : 1240008

Burlington, Ontario, L7L 6W6, Canada

RECRUITING

Investigational Site Number : 1240007

Hamilton, Ontario, L8S 1G5, Canada

RECRUITING

Investigational Site Number : 1240006

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Investigational Site Number : 1240005

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

Investigational Site Number : 2030001

Prague, 190 00, Czechia

RECRUITING

Investigational Site Number : 2500005

Créteil, 94010, France

RECRUITING

Investigational Site Number : 2500001

Lille, 59000, France

RECRUITING

Investigational Site Number : 2500004

Nice, 06200, France

RECRUITING

Investigational Site Number : 2500002

Paris, 75019, France

RECRUITING

Investigational Site Number : 2500003

Paris, 75571, France

RECRUITING

Investigational Site Number : 2760002

Düsseldorf, 40217, Germany

RECRUITING

Investigational Site Number : 2760004

Frankfurt, 60590, Germany

RECRUITING

Investigational Site Number : 2760001

Leipzig, 04103, Germany

RECRUITING

Investigational Site Number : 3000001

Athens, 115 27, Greece

RECRUITING

Investigational Site Number : 3000003

Athens, 152 36, Greece

RECRUITING

Investigational Site Number : 3480005

Budapest, 1085, Hungary

RECRUITING

Investigational Site Number : 3480004

Debrecen, 4032, Hungary

RECRUITING

Investigational Site Number : 3480002

Székesfehérvár, 8000, Hungary

RECRUITING

Investigational Site Number : 3480001

Szigetvár, 7900, Hungary

RECRUITING

Buzzi Children's Hospital - Investigational Site Number : 3800003

Milan, Lombardy, 20154, Italy

RECRUITING

Investigational Site Number : 3800005

Padua, Padova, 35128, Italy

RECRUITING

Ospedale Pediatrico Bambino Gesù - Investigational Site Number : 3800002

Rome, Roma, 00165, Italy

RECRUITING

AOU Luigi Vanvitelli - Investigational Site Number : 3800004

Naples, 80131, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo - Investigational Site Number : 3800001

Pavia, 27100, Italy

RECRUITING

Investigational Site Number : 3920006

Isehara, Kanagawa, 259-1193, Japan

RECRUITING

Investigational Site Number : 3920004

Tsu, Mie-ken, 514-0125, Japan

RECRUITING

Investigational Site Number : 3920003

Ureshino, Saga-ken, 843-0393, Japan

RECRUITING

Investigational Site Number : 3920002

Fukuoka, 811-1394, Japan

RECRUITING

Investigational Site Number : 3920001

Fukuoka, 813-0017, Japan

RECRUITING

Investigational Site Number : 4840001

San Juan del Río, Querétaro, 76800, Mexico

RECRUITING

Investigational Site Number : 4840004

Durango, 34000, Mexico

RECRUITING

Investigational Site Number : 4840002

Veracruz, 91900, Mexico

RECRUITING

Investigational Site Number : 5280001

Rotterdam, 3015 CE, Netherlands

COMPLETED

Investigational Site Number : 6160004

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

RECRUITING

Investigational Site Number : 6160001

Lodz, Lódzkie, 93-509, Poland

RECRUITING

Investigational Site Number : 6160003

Warsaw, Masovian Voivodeship, 02-091, Poland

RECRUITING

Investigational Site Number : 7240003

Santiago de Compostela, A Coruña [La Coruña], 15706, Spain

RECRUITING

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Investigational Site Number : 7240007

Esplugues de Llobregat, Barcelona [Barcelona], 08950, Spain

RECRUITING

Investigational Site Number : 7240002

Sabadell, Barcelona [Barcelona], 08208, Spain

RECRUITING

Investigational Site Number : 7240006

Jerez de la Frontera, Cádiz, 11407, Spain

RECRUITING

Investigational Site Number : 7240005

Madrid, 28009, Spain

RECRUITING

Investigational Site Number : 7240004

Valencia, 46026, Spain

RECRUITING

Investigational Site Number : 8260003

Birmingham, England, B4 6NH, United Kingdom

RECRUITING

Investigational Site Number : 8260002

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

Investigational Site Number : 8260001

London, London, City of, SE5 9RL, United Kingdom

RECRUITING

Investigational Site Number : 8260004

Bradford, BD9 6RJ, United Kingdom

RECRUITING

Related Links

• EFC14771 Plain Language Results Summary

MeSH Terms

Conditions

Respiratory Sounds; Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: January 3, 2024
• Primary Completion (Estimated): December 21, 2028
• Study Completion (Estimated): December 21, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

IT (5); HU (4); PL (3); ES (7); CZ (1); JP (5); GR (2); DE (3); NL (1); ME (3); FR (5); US (14); BR (3); CA (6); GB (4); AR (8)