drugset / Trial / NCT06293053

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

NCT06293053

Phase 3 Recruiting 18 enrolled Sanofi Regeneron Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-05-15
Primary completion
2027-10-28
Completion
2027-11-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Dupilumab Monoclonal antibody Subcutaneous

Indications