Chronic Pruritus of Unknown OriginPhase 3NCT07700056
A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
A Phase 3 study testing Remibrutinib in people with Chronic Pruritus of Unknown Origin, run by Novartis Pharmaceuticals at 17 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pruritus of Unknown Origin
- What is being tested?
- Remibrutinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 17 sitesin 5 countries
- Study dates
- 24 Aug 2026to 15 Apr 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
17 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
17 sites in 5 countries
United States8 sites, 8 recruiting
- Recruiting
Optima Research-Boardman
Boardman, Ohio, 44512
Sarah Merlo, smerlo@optimatrials.com
Patrick Shannon
- Recruiting
Dawes Fretzin Clinical Rea Group
Indianapolis, Indiana, 46256
Joan Prusa, +1 317 516 5030#102, jprusa@ecommunity.com
Kenneth Dawes
- Recruiting
Driven Research
Miami, Florida, 33126
Haymara Gonzalez, hgonzalez@drivenclinicalresearch.com
Javier Alonso Llamazares
- Recruiting
Southern IN Clinical Trials
New Albany, Indiana, 47150
Misty Humphress, mhumphress@soinct.com
Megan Landis
- Recruiting
National Allergy and Asthma Research LLS
North Charleston, South Carolina, 29420
Donnis June Warren, +1 843 820 1036, JWarren@nationalallergyandent.com
John T Ramey
- Recruiting
Austin Inst for Clinical Research
Pflugerville, Texas, 78660
Alivia Hernandez, +1 512 279 2545, ahernandez@atxresearch.com
Edward Lain
- Recruiting
Aeroallergy Research Laboratories
Savannah, Georgia, 31406
Susie Gault, +1 912 356 3619, sgault@coastalallergy.net
Brad Goodman
- Recruiting
Equity Medical
The Bronx, New York, 10455
Rocio Vaquero, rvaquero@equity-med.com
Michael Cameron
Japan3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Sakai, Osaka, 5938324
- Recruiting
Novartis Investigative Site
Tachikawa, Tokyo, 1900023
- Recruiting
Novartis Investigative Site
Yokohama, Kanagawa, 2400013
South Korea3 sites, 3 recruiting
- Recruiting
Novartis Investigative Site
Ansan, Gyeonggi-do, 15355
- Recruiting
Novartis Investigative Site
Seoul, 03722
- Recruiting
Novartis Investigative Site
Seoul, 07804
Canada2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Hamilton, Ontario, L8L 3C3
- Recruiting
Novartis Investigative Site
Québec, Quebec, G1W 4R4
Argentina1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Rosario, Santa Fe Province, S2000DBS
About this study
Official title: 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)
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).
Read the 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.
- Conditions
- Chronic Pruritus of Unknown Origin
- Being tested
- Remibrutinib, Placebo
- Keywords
- BTK inhibitor, chronic pruritus, chronic pruritus of unknown origin, CPUO, remibrutinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemibrutinibDrug
Also called LOU064
Oral administration of remibrutinib
PlaceboDrug
Oral administration of matching placebo.
| Study group | Role | What they receive |
|---|---|---|
| Remibrutinib | Experimental | Remibrutinib film coated tablets Receives: Drug: Remibrutinib |
| Placebo followed by remibrutinib | Experimental | Matching placebo. At the Week 24 visit, all participants will receive active treatment (remibrutinib). Receives: Drug: Remibrutinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 12
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start24 Aug 2026
- Primary completion19 Dec 2029 (estimated)
- Study completion15 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pruritus of Unknown OriginStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700056
- Sponsor's protocol ID
- CLOU064R12301
- Other IDs
- 2025-524497-41, 2025
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com