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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join 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: OR 2 minor criteria:
  • Physician diagnosed Atopic Dermatitis,
  • Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L).
  • 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 be able to join if…

• 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 this trial is running

• 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

+ 62 more sites.

Who to contact

Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06191315.