Overview

A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants >=2 Years to <12 Years of Age With Uncontrolled Chronic Spontaneous Urticaria (CSU) or Chronic Inducible Cold Urticaria (CICU) (LIBERTY-CSU/CINDU CUPIDKids)

Status:
Recruiting

Trial end date:
2024-06-07

Target enrollment:

Participant gender:

Summary

This is a multicenter, single-arm, 24-week treatment, Phase 3 PKM16982 study. The purpose of this study is to investigate the Pharmacokinetics (PK) and safety of dupilumab in children diagnosed with CSU or CICU who remain symptomatic despite the use of H1-antihistamine treatment and/or appropriate preventive measures. Study details include: Screening: 2 to 4 weeks; The treatment duration will be 24 weeks; Follow-up period: 12 weeks; The study duration will be 38 to 40 weeks (including screening and follow-up); The number of study visits will be 8.

Phase:

Phase 3

Details

Lead Sponsor:

Sanofi

Collaborator:

Regeneron Pharmaceuticals