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NCT05526521 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 15
- Enrollment target
- 15
- Study locations
NCT05526521: Completed Phase 3 study of Chronic Spontaneous Urticaria, sponsored by Sanofi.
NCT05526521 is a Phase 3 study of Chronic Spontaneous Urticaria that has completed, run by Sanofi. The registered enrollment target is 15 participants, below the 1,426-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (99% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05526521, a Phase 3 study of Chronic Spontaneous Urticaria, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 15 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
Blood samples were collected at specified timepoints to obtain dupilumab concentration.
Conditions Studied
Interventions
- DRUG Dupilumab
Study Locations (15)
New York
- Boston Childrens Health Physicians Site Number : 8400017 - Hawthorne
- Columbia University Irving Medical Center Site Number : 8400003 - New York
Ohio
- Childrens Hospital Medical Center of Akron- Site Number : 8400020 - Akron
- Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400001 - Cincinnati
Alberta
- Investigational Site Number : 1240009 - Calgary
- Investigational Site Number : 1240010 - Edmonton
Florida
- Pediatric Dermatology of Miami Site Number : 8400015 - Coral Gables
Idaho
- Treasure Valley Medical Research Site Number : 8400019 - Boise
Missouri
- Washington University School of Medicine- Site Number : 8400004 - St Louis
Oklahoma
- Vital Prospects Clinical Research Institute, P.C.- Site Number : 8400002 - Tulsa
Tennessee
- Monroe Carell Jr. Childrens Hospital at Vanderbilt- Site Number : 8400005 - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2025-02-03 |
| Phase | Phase 3 |
What the finished NCT05526521 record still lists
NCT05526521 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,426-participant average among 18 other Chronic Spontaneous Urticaria trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Chronic Spontaneous Urticaria appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab is the first listed.
NCT05526521 lists 15 locations in 12 states (New York, Ohio, Alberta).
Frequently Asked Questions
What is clinical trial NCT05526521 about?
NCT05526521 is a clinical study titled "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)". 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 ...
What is the current status of trial NCT05526521?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2022-08-25. Estimated completion is 2025-02-03.
What conditions does trial NCT05526521 study?
This clinical trial studies the following conditions: Chronic Spontaneous Urticaria.
What interventions are being tested in trial NCT05526521?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT05526521?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05526521 being conducted?
This trial has 15 study locations across Florida, Idaho, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05526521's enrollment target sits among peer trials
15 19th of 18 the lowest of 18 other Chronic Spontaneous Urticaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Spontaneous Urticaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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