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A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis
NCT06293053 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06293053
The ClinicalTrials.gov registry entry for NCT06293053 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06293053 reports 14 study locations spanning 7 distinct geographic areas — top geographies include Florida, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06293053?
The interventions under investigation include: Dupilumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06293053?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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