Clareo Health | A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) (LIBERTY-CSU CUPIDKids)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sanofi
Age
2–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant must be ≥ 2 years to \<12 years of age, at the time of signing the informed consent.
Participants who had history of a diagnosis of CSU prior to screening (Visit 1) or symptoms consistent with a diagnosis of CSU for at least 3 months in the Investigator's opinion.
Participants with CSU (characterized by recurrent itchy wheals with or without angioedema for \>6 weeks) who remain symptomatic at the time of screening despite regular H1-antihistamine treatment.
Body weight within ≥5 kg to \<60 kg.
Participant/parent(s)/caregiver(s)/participant's legally authorized representative, as appropriate, willing and able to comply with study visits and related procedures.
You may not be if
Participants were excluded from the study if any of the following criteria apply:
Underlying etiology for chronic urticarias other than CSU.
Presence of skin morbidities other than CSU that may interfere with the assessment of the study outcomes.
Participants with a diagnosis of chronic inducible cold urticaria.
Participants with active AD.
Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated.
Diagnosed with, suspected of, or at high risk of endoparasitic infection.
Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the screening visit or during the screening period.
Known or suspected immunodeficiency.
Active malignancy or history of malignancy within 5 years before the baseline visit.
History of systemic hypersensitivity or anaphylaxis to dupilumab including any excipient.
Participation in prior dupilumab clinical study or have been treated with commercially available dupilumab.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
