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 placebo arm will be switched to remibrutinib at Week 24. * Safety follow-up period: 4 weeks of treatment-free safety follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Oral administration of remibrutinib
Oral administration of matching placebo.
Aeroallergy Research Laboratories
Savannah, Georgia, United States
RECRUITINGDawes Fretzin Clinical Rea Group
Indianapolis, Indiana, United States
RECRUITINGOptima Research-Boardman
Boardman, Ohio, United States
Proportion of participants achieving ≥4 point reduction from baseline in Worst itch Numerical Rating Scale (WI NRS)
The WI-NRS is a patient-reported outcome (PRO) instrument consisting of a single question that asks participants to rate the severity of their worst itch over a defined period. The score range is from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate worse itch severity.
Time frame: Baseline, Week 12
Proportion of participants achieving ≥4 point reduction from baseline in WI NRS
The WI-NRS is a PRO instrument consisting of a single question that asks participants to rate the severity of their worst itch over a defined period. The score range is from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate worse itch severity.
Time frame: Baseline, Week 4
Proportion of participants achieving Patient Global Impression of Severity (PGIS) score of 0 (none) or 1 (mild)
The PGIS of pruritus is a PRO measure consisting of a single item that captures the participant's overall self-assessment of the severity of their pruritus (itch) over a defined recall period. The score range is from 0 (none) to 3 (severe). Lower scores indicate better outcome.
Time frame: Week 12
Proportion of participants achieving Patient Global Impression of Severity (PGIS) score of 0 (none) or 1 (mild)
The PGIS of pruritus is a PRO measure consisting of a single item that captures the participant's overall self-assessment of the severity of their pruritus (itch) over a defined recall period. The score range is from 0 (none) to 3 (severe). Lower scores indicate better outcome.
Time frame: Week 24
Change from baseline in Pruritus-related Sleep Disturbance Numerical Rating Scale (SD-NRS)
The SD-NRS is a PRO instrument used to assess the degree of sleep disturbance caused by pruritus (itch). The score range is from 0 (No sleep disturbance) to 10 (Worst possible sleep disturbance). Higher scores indicate greater sleep disturbance due to pruritus.
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Austin Inst for Clinical Research
Pflugerville, Texas, United States
RECRUITINGNovartis Investigative Site
Tachikawa, Tokyo, Japan
RECRUITINGTime frame: Week 12
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs.
Time frame: Up to Week 52