NCT06293053

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis

A Multicenter Open-label Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

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

• Prurigo Nodularis

Interventions

Type	Name	Description
DRUG	Dupilumab	Pharmaceutical form: Injection solution Route of administration: Subcutaneous

Timeline

• Start date: 2024-05-15
• Primary completion: 2027-10-28
• Completion: 2027-11-03
• First posted: 2024-03-05
• Last updated: 2026-01-15

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study