A Phase 3 interventional study of Remibrutinib and Placebo in Chronic Pruritus of Unknown Origin, sponsored by Novartis Pharmaceuticals. Recruiting at 12 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
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:
490 studies on the registry are indexed under Pruritus; 93 are open to participants now.
This study's planned enrollment of 180 is above the median of 60 across 422 interventional studies indexed under Pruritus.
Browse Pruritus studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Remibrutinib film coated tablets
Drug: Remibrutinib
Matching placebo. At the Week 24 visit, all participants will receive active treatment (remibrutinib).
Drug: Remibrutinib · Drug: Placebo
Oral administration of remibrutinib
Also known as: LOU064
Oral administration of matching placebo.
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.
Time 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
Plan to share: 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 https://www.clinicalstudydatarequest.com/.
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Feb 2029, 28 months after the start.
Of 42 industry-sponsored phase 3 interventional studies under Pruritus, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 27. This study's planned 28 months is above that.
Counting every sponsor, half of 48 studies reached it within 19 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Remibrutinib