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NCT07700056PHASE3Recruiting

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

Novartis Pharmaceuticals

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

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 distribution). * Participants with ongoing, severe chronic pruritus despite the use of emollients and who are candidates for systemic therapy. * Participants must have severe itch defined by a WI-NRS ≥7 at screening; score scale ranges from 0 to 10; higher score indicates worse itch. * Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization/baseline visit. * The average WI-NRS score over the preceding 7 days prior to the randomization/baseline visit will be calculated based on the daily WI-NRS scores (0-10). * Participants must have PGIS of pruritus scored as 3 "severe" at screening and baseline visits. Key Exclusion Criteria: * Any active skin conditions (e.g., atopic dermatitis, psoriasis, etc.) that may interfere with the assessment of CPUO. * Known systemic condition(s) or medication(s) that are considered by the investigator to be the primary cause of current pruritus. * Known or suspected infectious disease that is active, chronic or recurrent which precludes the participant from participating in the clinical trial as per Investigator´s assessment. These infectious diseases include but are not limited to opportunistic infections (e.g., tuberculosis, atypical mycobacterioses, listeriosis or aspergillosis) and/or known or suspected HIV infection. * History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. * Significant bleeding risk or coagulation disorders. History of gastrointestinal bleeding, e.g., in association with use of nonsteroidal anti-inflammatory drugs (NSAIDs), that was clinically relevant (e.g., where intervention was indicated or requiring hospitalization or blood transfusion). Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited. * History or current hepatic disease, including but not limited to, acute or chronic hepatitis, cirrhosis or hepatic failure or aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) levels of more than 1.5 x upper limit of normal (ULN) or International Normalized Ratio (INR) of more than 1.5 at screening.

Interventions

DRUG

Remibrutinib

DRUG

Placebo

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Conditions

Chronic Pruritus of Unknown Origin

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