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NCT07700056From ClinicalTrials.govRecruiting

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

A 52-week Multi-center, Randomized, Double-blind, Placebo Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)

  • Chronic Pruritus of Unknown Origin

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Novartis Pharmaceuticals
Enrolment target
180
Started
24 August 2026
Main results due
19 December 2029
Study sites
13
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(13)

  • Driven Research

    Miami, Florida, United States

    Recruiting

  • Aeroallergy Research Laboratories

    Savannah, Georgia, United States

    Recruiting

  • Dawes Fretzin Clinical Rea Group

    Indianapolis, Indiana, United States

    Recruiting

  • Equity Medical

    The Bronx, New York, United States

    Recruiting

  • Optima Research-Boardman

    Boardman, Ohio, United States

    Recruiting

  • National Allergy and Asthma Research LLS

    North Charleston, South Carolina, United States

    Recruiting

  • Austin Inst for Clinical Research

    Pflugerville, Texas, United States

    Recruiting

  • Novartis Investigative Site

    Hamilton, Ontario, Canada

    Recruiting

  • Novartis Investigative Site

    Québec, Quebec, Canada

    Recruiting

  • Novartis Investigative Site

    Sakai, Osaka, Japan

    Recruiting

  • Novartis Investigative Site

    Tachikawa, Tokyo, Japan

    Recruiting

  • Novartis Investigative Site

    Ansan, Gyeonggi-do, South Korea

    Recruiting

  • Novartis Investigative Site

    Seoul, South Korea

    Recruiting

Showing 13 of 13 sites. 13 of the 13 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07700056. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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