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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 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.

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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.

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

FieldValue
Enrollment Target 18 participants
Start Date 2024-05-15
Est. Completion 2027-11-03
Phase Phase 3

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT06293053

The ClinicalTrials.gov registry entry for NCT06293053 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 228-participant average among 14 other Prurigo Nodularis trials with a reported enrollment target (92% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 reports 14 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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