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
Sanofi
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.
Eligibility
- Age range
- 0–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be ≥6 months to \<18 years of age, at the time of signing the informed consent. * A clinical diagnosis of prurigo nodularis (PN) at least 3 months prior to screening, an Investigator's global assessment for prurigo nodularis stage (IGA PN-S) score of ≥2 with presence of ≥6 pruriginous lesions at Baseline. The lesions should be present on ≥2 different body surface areas at Baseline. * On the worst itch numerical rating scale (WI-NRS) (for participants aged ≥6 years to \<18 years old at the screening visit) or worst-scratch/itch NRS (for participants aged…