Efficacy and safety of subcutaneous dupilumab in participants with asthma/asthmatic wheeze aged 2 to <6 years

Phase 1

Recruiting

• Conditions: Respiratory tract diseases - Wheezing, Asthma; MedDRA version: 21.0Level: PTClassification code: 10047924Term: Wheezing Class: 100000004855; MedDRA version: 20.0Level: PTClassification code: 10003553Term: Asthma Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-504331-41-00
• Lead Sponsor: Sanofi-Aventis Research & Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 146

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: a) Physician diagnosed Atopic Dermatitis, b) Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value =0.35 kU/L). OR 2 minor critieria: 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

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 dupilumab or any other 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 clinical trial of medicinal product
• Study Design: Not specified