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

NCT07700056 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLOU064R123012025-524497-41
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Chronic Pruritus of Unknown Origin

Keywords

BTK inhibitor; chronic pruritus; chronic pruritus of unknown origin; CPUO; remibrutinib

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Week 12

Secondary Outcomes (5)

• Proportion of participants achieving ≥4 point reduction from baseline in WI NRS

  Baseline, Week 4

• Proportion of participants achieving Patient Global Impression of Severity (PGIS) score of 0 (none) or 1 (mild)

  Week 12

• Proportion of participants achieving Patient Global Impression of Severity (PGIS) score of 0 (none) or 1 (mild)

  Week 24

• Change from baseline in Pruritus-related Sleep Disturbance Numerical Rating Scale (SD-NRS)

  Week 12

• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Week 52

Study Arms (2)

Remibrutinib

EXPERIMENTAL

Remibrutinib film coated tablets

Drug: Remibrutinib

Placebo followed by remibrutinib

EXPERIMENTAL

Matching placebo. At the Week 24 visit, all participants will receive active treatment (remibrutinib).

Drug: Remibrutinib; Drug: Placebo

Interventions

Remibrutinib DRUG

Oral administration of remibrutinib

Also known as: LOU064

Placebo followed by remibrutinib; Remibrutinib

Placebo DRUG

Oral administration of matching placebo.

Placebo followed by remibrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

remibrutinib

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): August 14, 2026
• Primary Completion (Estimated): December 19, 2029
• Study Completion (Estimated): April 15, 2030
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share