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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)

NCT05526521

CompletedPhase 3

Sponsor: Sanofi

Conditions: Chronic Spontaneous Urticaria

Interventions: Dupilumab

Countries: United States, Canada, Japan

This was a multicenter, single-arm, 24-week treatment, Phase 3 study. The purpose of this study was to investigate the PK and safety of dupilumab in children diagnosed with CSU who remain symptomatic despite the use of H1-antihistamine treatment. Study details included: Screening: 2 to 4 weeks; The treatment duration was 24 weeks; Follow-up period: 12 weeks; The study duration was 38 to 40 weeks (including screening and follow-up); The number of study visits was 6.

Eligibility overview

Sex: ALL

Age: 2 Years to 11 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

Locations (15)

Coral Gables, Florida, United States
Boise, Idaho, United States
St Louis, Missouri, United States
Hawthorne, New York, United States
New York, New York, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Tulsa, Oklahoma, United States
Nashville, Tennessee, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
Montreal, Quebec, Canada
Yokohama, Kanagawa, Japan
Tsu, Mie-ken, Japan