Pharmacokinetics, Immunogenicity and Safety of Subcutaneous Dupilumab and Berahyaluronidase Alfa (ALT-B4) Coformulation

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-07-25

Summary

This is a Phase 3, open label, randomized, parallel-group, 2-arm study. The purpose of this study is to measure PK, immunogenicity, safety and, tolerability of dupilumab hyaluronidase coformulation compared with dupilumab approved formulation in male or female participants with moderate-to-severe atopic dermatitis (AD) aged 12 years of age. Study details as follows:

• The study duration includes screening period up to 4 weeks + treatment period of 20 weeks ( 3 days) and follow-up of 12 weeks ( 7 days).
• The number of on-site visits will be 10 and one phone contact will be scheduled (during the follow-up period).

• Phase: PHASE3

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: dupilumab