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180 Participants NeededMy employer runs this trial

Remibrutinib for Chronic Itch

Recruiting at 4 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Are You a Good Fit for This Trial?

This trial is for adults (18+) who have had severe, unexplained chronic itch affecting at least two body areas (trunk, arms, or legs) for at least 4 months. Their itch must be rated as severe and not caused by skin diseases, nerve problems, mental health issues, medications, or allergies.

Inclusion Criteria

I have severe itching, rated as 3, at both screening and baseline visits.
I am 18 years old or older.
Participants must have an average WI-NRS ≥7 over the 7 days prior to randomization/baseline visit
See 6 more

Exclusion Criteria

My itching is mainly caused by another health condition or medication I am taking.
I do not have active skin conditions like eczema or psoriasis.
I have an active, chronic, or recurring infectious disease or HIV infection.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Remibrutinib

Trial Overview

The study compares remibrutinib—a new oral medication—to a placebo in people with severe chronic itch of unknown cause. Participants are randomly assigned to receive either the drug or placebo to see if remibrutinib helps reduce itching.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: RemibrutinibExperimental Treatment1 Intervention
Group II: Placebo followed by remibrutinibExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials
2,963
Recruited
4,275,000+
Founded
1996
Headquarters
Basel, Switzerland
Known For
Precision medicine
Top Products
Gleevec, Cosentyx, Entresto, Kisqali
Dr. Vas Narasimhan profile image

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye profile image

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

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