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)
Public ClinicalTrials.gov record NCT05526521. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT05526521
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 15 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 24, 2022
- Primary completion
- Nov 10, 2024
- Completion
- Feb 2, 2025
- Last update posted
- Nov 24, 2025
2022 – 2025
United States locations
- U.S. sites
- 9
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pediatric Dermatology of Miami Site Number : 8400015 | Coral Gables | Florida | 33146 | — |
| Treasure Valley Medical Research Site Number : 8400019 | Boise | Idaho | 83706 | — |
| Washington University School of Medicine- Site Number : 8400004 | St Louis | Missouri | 63110 | — |
| Boston Childrens Health Physicians Site Number : 8400017 | Hawthorne | New York | 10532 | — |
| Columbia University Irving Medical Center Site Number : 8400003 | New York | New York | 10032 | — |
| Childrens Hospital Medical Center of Akron- Site Number : 8400020 | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400001 | Cincinnati | Ohio | 45229-3026 | — |
| Vital Prospects Clinical Research Institute, P.C.- Site Number : 8400002 | Tulsa | Oklahoma | 74136 | — |
| Monroe Carell Jr. Childrens Hospital at Vanderbilt- Site Number : 8400005 | Nashville | Tennessee | 37232 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05526521, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 24, 2025 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05526521 live on ClinicalTrials.gov.