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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Wheezing, Asthma

In brief

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).

Key facts

Study ID

NCT06191315

Run by

Sanofi

People needed

90

Starts

2024-01-03

Expected to finish

2028-12-21

Last updated by the study team

2026-03-20

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Phoenix Children's Hospital- Site Number : 8400001 — Phoenix, Arizona, United States (enrolling)
• Investigational Site Number : 1240001 — Vancouver, British Columbia, Canada (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago- Site Number : 8400011 — Chicago, Illinois, United States (enrolling)
• Allervie Clinical Research - Destin- Site Number : 8400016 — Destin, Florida, United States (enrolling)
• Investigational Site Number : 1240002 — Edmonton, Alberta, Canada (enrolling)
• UBMD Pediatrics- Site Number : 8400013 — Buffalo, New York, United States (enrolling)
• Boston Children's Health Physicians - Hawthorne- Site Number : 8400010 — Hawthorne, New York, United States (enrolling)
• UNC Children's Hospital- Site Number : 8400005 — Chapel Hill, North Carolina, United States (enrolling)
• Cincinnati Children's Hospital Medical Center- Site Number : 8400004 — Cincinnati, Ohio, United States (enrolling)
• Allergy and Asthma Specialist- Site Number : 8400002 — Owensboro, Kentucky, United States (enrolling)
• EMDA Clinical Research- Site Number : 8400026 — Miami, Florida, United States (enrolling)
• South Texas Medical Research Institute - TTS Research- Site Number : 8400022 — Boerne, Texas, United States (enrolling)
• Texas Children's Hospital- Site Number : 8400027 — Houston, Texas, United States (enrolling)
• Investigational Site Number : 0320005 — Rosario, Santa Fe Province, Argentina (enrolling)
• Investigational Site Number : 0320008 — Buenos Aires, Argentina (enrolling)
• Investigational Site Number : 0320003 — Buenos Aires, Argentina (enrolling)
• Investigational Site Number : 0320002 — Buenos Aires, Argentina (enrolling)
• Investigational Site Number : 0320001 — Buenos Aires, Argentina (enrolling)
• Investigational Site Number : 0320009 — Corrientes, Argentina (enrolling)
• Investigational Site Number : 0320006 — Córdoba, Argentina (enrolling)
• Investigational Site Number : 0320004 — Mendoza, Argentina (enrolling)
• University Hospitals Cleveland Medical Center- Site Number : 8400015 — Cleveland, Ohio, United States (enrolling)
• Vanderbilt University Medical Center- Site Number : 8400024 — Nashville, Tennessee, United States (enrolling)
• Mayo Clinic in Rochester - Minnesota- Site Number : 8400008 — Rochester, Minnesota, United States (enrolling)
• Investigational Site Number : 1240008 — Burlington, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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