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Completed Phase 3 Interventional Results available

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)

ClinicalTrials.gov ID: NCT05526521

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.

ClinicalTrials.gov public records Last synced Oct 25, 2026, 7:31 AM EDT

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
Lead sponsor
Sanofi
Industry
Enrollment
15 participants

Conditions and interventions

Interventions

Drug

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 25, 2022 (Actual)
Primary completion
Nov 11, 2024 (Actual)
Completion
Feb 3, 2025 (Actual)
Last update posted
Nov 25, 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 25, 2025 · Synced Oct 25, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05526521 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →