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

Conditions

• Chronic Pruritus of Unknown Origin

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Remibrutinib — DRUG
  Oral administration of remibrutinib
• Placebo — DRUG
  Oral administration of matching placebo.

Study Details

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).

Key Dates

First listed

Jul 13, 2026

Start date

Aug 24, 2026

Status verified

Aug 2026

Primary completion

Dec 19, 2029

Completion

Apr 15, 2030

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Remibrutinib
  Remibrutinib film coated tablets
• Experimental: Placebo followed by remibrutinib
  Matching placebo. At the Week 24 visit, all participants will receive active treatment (remibrutinib).

Primary Outcome Measure

Proportion of participants achieving ≥4 point reduction from baseline in Worst itch Numerical Rating Scale (WI NRS) [ Time Frame: Baseline, Week 12 ]

Central Contacts

• Novartis Pharmaceuticals
  1-888-669-6682
  [email protected]
• Novartis Pharmaceuticals
  +41613241111

Locations (4)

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