A Phase 3 interventional study of Remibrutinib and Placebo in Chronic Pruritus of Unknown Origin, sponsored by Novartis Pharmaceuticals. Recruiting at 13 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Novartis Pharmaceuticals · 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:
Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
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 www.clinicalstudydatarequest.com
No publications or documents are linked to this record.
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 ↗
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Novartis Pharmaceuticals