Belleair

Researchers are evaluating the safety and effectiveness of dupilumab in adults aged 18 to 90 years with chronic pruritus of unknown origin (CPUO), a condition causing severe itching without a known cause. This master protocol includes two parallel, double-blind, placebo-controlled Phase 3 studies (Study A and Study B) designed to assess dupilumab's impact on reducing itch severity. Both studies involve participants experiencing severe itch despite prior treatments and exclude those with pruritus caused by other known conditions. Participants first undergo up to a 4-week screening period, followed by a 4-week run-in phase where they receive a non-sedative antihistamine and an emollient. Those with severe itch at baseline are then randomly assigned to receive either subcutaneous dupilumab or a matching placebo for 24 weeks, alongside the antihistamine and emollient. After treatment, a 12-week follow-up phase monitors participants. Study durations for both studies can last up to 44 weeks per participant. During the study, participants are assessed for changes in itch severity using the worst-itch numerical rating scale (WI-NRS) and patient global impression of severity (PGIS). Researchers track the proportion of participants who achieve significant itch reduction by Week 24 in Study A and by Week 12 in Study B. Safety and efficacy are monitored throughout treatment and follow-up, with participant involvement including regular evaluations, questionnaires, and adherence to the assigned treatment regimen.