Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
With
Regeneron Pharmaceuticals
The duration per participant is up to 120 Weeks.
Age
2–5
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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:
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.
You may not be if
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.
Clareo Health | Efficacy and Safety of Subcutaneous Dupilumab in Participants With Asthma/Asthmatic Wheeze Aged 2 to <6 Years (LIBERTY ASTHMA TREKIDS)
