Evaluating Dupilumab Injection for Adults Aged 18 to 90 with Chronic Itching of Unknown Cause CPUO in Two Phase 3 Studies

What this Trial Is About

Researchers are evaluating the effectiveness and safety of dupilumab in adults aged 18 to 90 years with chronic pruritus of unknown origin CPUO, a condition causing severe itch without a known cause. This Phase 3 study involves two parallel double-blind trials, Study A and Study B, designed to assess dupilumabs impact on severe itch compared to placebo while participants also use non-sedative antihistamines and moisturizers. The study includes a screening period, a run-in period, and treatment followed by a follow-up. Participants will first undergo up to 4 weeks of screening, then a 4-week run-in period during which they receive non-sedative antihistamines and emollients. Those with severe itch scores will be randomly assigned to receive either dupilumab or placebo injections every two weeks for 24 weeks, alongside their antihistamine and moisturizer regimen. After treatment, participants will be followed up for 12 weeks to monitor ongoing effects and safety. During the study, participants will have regular assessments of their itch severity using a worst-itch numerical rating scale, quality of life questionnaires, and mental health evaluations. Researchers will monitor adverse events and immune responses to the drug. The total participation lasts up to 44 weeks, including screening, treatment, and follow-up, to evaluate changes in itch severity, sleep disturbance, and overall well-being.

Efficacy and Safety of Subcutaneous Dupilumab for the Treatment of Adult Participants With Chronic Pruritus of Unknown Origin (CPUO) (LIBERTY-CPUO-CHIC)