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Sponsor: Sanofi
Conditions: Wheezing, Asthma
Interventions: Dupilumab, Placebo
Countries: United States, Argentina, Brazil, Canada, Czechia, France, Germany, Greece
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).
Sex: ALL
Age: 2 Years to 5 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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:
1. Physician diagnosed Atopic Dermatitis,
2. Allergic sensitization to at least 1 aeroallergen (with a positive serum IgE defined as a value ≥0.35 kU/L).
OR 2 minor criteria:
3. Wheezing unrelated to colds,
4. Peripheral blood eosinophilia ≥4%,
5. 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).
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.- Phoenix, Arizona, United States
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- Nashville, Tennessee, United States
- Boerne, Texas, United States
- Houston, Texas, United States
- Rosario, Santa Fe Province, Argentina
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- Buenos Aires, Argentina
- Corrientes, Argentina
- Córdoba, Argentina
- Mendoza, Argentina
- Porto Alegre, Rio Grande do Sul, Brazil
- Sorocaba, São Paulo, Brazil
- São Paulo, Brazil
- Edmonton, Alberta, Canada
- Vancouver, British Columbia, Canada
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