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NCT06293053 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
A Phase 3 study of Prurigo Nodularis, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
- 14
- Study locations
NCT06293053: Recruiting Phase 3 study of Prurigo Nodularis, sponsored by Sanofi.
NCT06293053 is a Phase 3 study of Prurigo Nodularis that is actively recruiting participants, run by Sanofi. The registered enrollment target is 18 participants, below the 228-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (92% lower). The trial reports 14 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06293053, a Phase 3 study of Prurigo Nodularis, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
- 14
- Study locations
Study Summary
This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: * Screening period: 2 to 4 weeks. * Treatment period: 24 weeks. * Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each participant (including screening, treatment, and follow-up periods). The total number of planned study visits for each participant will be 6.
Primary Outcome
Concentration of dupilumab in serum over time
Conditions Studied
Interventions
- DRUG Dupilumab
Study Locations (14)
Florida
- Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology- Site Number : 8400005 - Coral Gables
- Life Clinical Trials - Coral Springs- Site Number : 8400018 - Coral Springs
- Direct Helpers Research Center- Site Number : 8400015 - Hialeah
- SunCoast Skin Solutions - Lutz- Site Number : 8400008 - Lutz
- USF Health- Site Number : 8400003 - Tampa
Texas
- Dell Children's Medical Center- Site Number : 8400007 - Austin
- Driscoll Children's Hospital- Site Number : 8400017 - Corpus Christi
- Texas Dermatology and Laser Specialists - San Antonio - Oakwell Court- Site Number : 8400020 - San Antonio
California
- Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400021 - Palo Alto
- Mission Dermatology Center- Site Number : 8400011 - Rancho Santa Margarita
Minnesota
- Tareen Dermatology - Eagan- Site Number : 8400022 - Eagan
Missouri
- MediSearch Clinical Trials- Site Number : 8400004 - Saint Joseph
North Dakota
- AXIS Clinicals - Fargo- Site Number : 8400013 - Fargo
Oklahoma
- Vital Prospects Clinical Research Institute - Tulsa- Site Number : 8400002 - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-05-15 |
| Est. Completion | 2027-11-03 |
| Phase | Phase 3 |
What NCT06293053 shows while recruiting
NCT06293053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 228-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Prurigo Nodularis appearing as the primary indexed condition, and to 1 intervention - of which Dupilumab is the first listed.
NCT06293053 lists 14 locations in 7 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT06293053 about?
NCT06293053 is a clinical study titled "A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis". This is a Phase 3, multicenter, open-label, pharmacokinetics (PK)/safety study. The study consists of 3 periods: * Screening period: 2 to 4 weeks. * Treatment period: 24 weeks. * Post-intervention follow-up period: 16 weeks. The study duration will be approximately 42 to 44 weeks for each particip...
What is the current status of trial NCT06293053?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2024-05-15. Estimated completion is 2027-11-03.
What conditions does trial NCT06293053 study?
This clinical trial studies the following conditions: Prurigo Nodularis.
What interventions are being tested in trial NCT06293053?
The interventions under investigation include: Dupilumab (DRUG).
Who is sponsoring clinical trial NCT06293053?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06293053 being conducted?
This trial has 14 study locations across California, Florida, Minnesota, Missouri, North Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06293053's enrollment target sits among peer trials
18 14th of 14 higher than 1 of 14 other Prurigo Nodularis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prurigo Nodularis 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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