Phase 2 Study of Dupilumab Added to Biologic Therapy for Adults with Hypereosinophilic Syndrome and Persistent Symptoms

What this Trial Is About

Researchers are evaluating the use of dupilumab combined with other treatments in adults with hypereosinophilic syndrome HES, a blood disorder causing high levels of eosinophils that can harm the lungs, skin, intestines, and other organs. The study focuses on people who have partial clinical response to eosinophil-depleting biologic drugs but still experience symptoms. This phase 2 trial aims to assess dupilumabs effect on reducing persistent symptoms and to monitor its safety in this patient group. Participants will continue their current eosinophil-lowering biologic therapy and add dupilumab injections, which they will learn to self-administer at home. The dosing schedule varies depending on symptoms, with injections every 1 to 2 weeks for 24 weeks. Those who benefit may continue treatment for another 24 weeks with possible tapering of other medications. The study includes up to 6 clinic visits and 7 remote visits over a total period of up to 48 weeks. Throughout the study, participants undergo blood and urine tests, heart function assessments, symptom surveys, and other tests tailored to their symptoms, such as breathing tests for lung issues or biopsies for gastrointestinal symptoms. Researchers track clinical improvement using symptom inventories and monitor blood eosinophil levels. A final visit occurs 12 weeks after the last dose to assess ongoing effects and safety.

Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents