A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin [CPUO] (NCT07700056)

This is a global, phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origins (CPUO). The design includes 4 periods, for a total duration of up to 60 weeks: Screening period: up to 4 weeks. Double-blind treatment period (treatment period 1, TP1): 24 weeks of double-blind treatment with remibrutinib or matching placebo. Open-label treatment period (treatment period 2, TP2): 28 weeks of open-label treatment with remibrutinib. The participants randomized to the placebo arm will be switched to remibrutinib at Week 24. Safety follow-up period: 4 weeks of treatment-free safety follow-up.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Johannes S Kern

Key inclusion data

Participant must be ≥ 18 years of age. Participants with chronic pruritus for at least 4 months prior to screening. Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and/or dermatomal in distribution). Known conditions that may be the primary cause of the current pruritus. Please note, other eligibility criteria may apply.