A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
Start Date
8/24/2026
Completion Date
4/15/2030
Summary
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).
Detailed Description
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 placebo arm will be switched to remibrutinib at Week 24. * Safety follow-up period: 4 weeks of treatment-free safety follow-up.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Remibrutinib
Placebo
Conditions
Locations
Driven Research
Miami, Florida 33126
United States
Aeroallergy Research Laboratories
Savannah, Georgia 31406
United States
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana 46256
United States
Southern IN Clinical Trials
New Albany, Indiana 47150
United States
Equity Medical
The Bronx, New York 10455
United States
Optima Research-Boardman
Boardman, Ohio 44512
United States
National Allergy and Asthma Research LLS
North Charleston, South Carolina 29420
United States
Austin Inst for Clinical Research
Pflugerville, Texas 78660
United States
Novartis Investigative Site
Rosario, Santa Fe Province S2000DBS
Argentina
Novartis Investigative Site
Hamilton, Ontario L8L 3C3
Canada
Novartis Investigative Site
Québec, Quebec G1W 4R4
Canada
Novartis Investigative Site
Yokohama, Kanagawa 2400013
Japan
Novartis Investigative Site
Sakai, Osaka 5938324
Japan
Novartis Investigative Site
Tachikawa, Tokyo 1900023
Japan
Novartis Investigative Site
Ansan, Gyeonggi-do 15355
South Korea
Novartis Investigative Site
Seoul, 03722
South Korea
Novartis Investigative Site
Seoul, 07804
South Korea