At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 15 enrolled
Drug / intervention
Dupilumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-center, Single-arm Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Male and Female Participants ≥2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU)
In Brief
A Phase 3 clinical trial evaluating Dupilumab for Chronic Spontaneous Urticaria. Completed, enrolled 15 participants across 15 sites in 3 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Spontaneous Urticaria
CountriesCanada, Japan, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
Enrollment StartAug 2022
First PostedSep 2022
Primary CompletionNov 2024
Study CompletionFeb 2025
TodayJul 2026
First PostedSep 2, 2022
Enrollment StartAug 25, 2022
Primary CompletionNov 11, 2024
Study CompletionFeb 3, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 3.8 years ago
Interventions
Dupilumabdrug
Injection solution Subcutaneous