Informations générales (source: ClinicalTrials.gov)
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Longterm Safety of Dupilumab in Children 2 to <6 Years of Age With Uncontrolled Asthma and/or Recurrent Severe Asthmatic Wheeze
Interventional
Phase 3
Sanofi (Voir sur ClinicalTrials)
janvier 2024
décembre 2028
05 avril 2025
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Ralph EPAUD | 31/01/2025 15:20:17 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Investigational Site Number : 2500001 - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500002 - 75019 - Paris - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500003 - 75571 - Paris - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500004 - 06200 - Nice - France | Contact (sur clinicalTrials) | ||||
| Investigational Site Number : 2500005 - 94010 - Créteil - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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.
- 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.
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 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).
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.