Novartis Pharmaceuticals
The purpose of this phase 3 study is to establish the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO).
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 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 pla…
Key Inclusion Criteria: * Participant must be ≥ 18 years of age, at the time of signing the informed consent. * Participants with chronic pruritus for at least 4 months prior to screening. * Chronic pruritus considered of unknown origin as assessed by the investigator at baseline (e.g., excluding chronic pruritus related to primary dermatological or systemic conditions, neuropathic or psychogenic origin or secondary to drugs or other allergen exposures). * Chronic pruritus must affect at least 2 of the following body areas: trunk, arms, or legs (cannot be unilateral and/or dermatomal in distr…
Oral administration of remibrutinib
Oral administration of matching placebo.