Efficacy and safety of subcutaneous dupilumab in participants with asthma/asthmatic wheeze aged 2 to <6 years (LIBERTY ASTHMA TREKIDS)

Recruiting

• Conditions: Wheezing, Asthma

• Registration Number: jRCT2071250019
• Lead Sponsor: Sanofi K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-12
• Last Update Posted: 2025-05-12

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

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 inhaled corticosteroids (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:
  a) Physician diagnosed Atopic Dermatitis, b) Allergic sensitization to at least 1 aeroallergen (with a positive serum immunoglobulin E [IgE] defined as a value >=0.35 kU/L). OR 2 minor criteria: c) Wheezing unrelated to colds, d) Peripheral blood eosinophilia >=4%, e) 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).

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period	Baseline through Week 52	Annualized rate of severe asthma exacerbations during the 52-week treatment period.
Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and adverse events (AEs) leading to permanent treatment discontinuation	Week 52 through Week 116	Incidence of TEAEs, SAEs, AESIs, and AEs leading to permanent treatment discontinuation.