Remibrutinib for Chronic Urticaria
(REMIX-1 Trial)

Recruiting in Palo Alto (17 mi)

+144 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called remibrutinib to help adults with chronic hives that don't improve with standard allergy medicines. The medication works by blocking signals in the body that cause inflammation and allergic reactions. Remibrutinib has shown promising results in treating chronic spontaneous urticaria.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adults over 18 with chronic spontaneous urticaria (CSU) not well-managed by H1-antihistamines can join this trial. They must have had CSU for at least 6 months, experience itch and hives despite current treatment, and be able to keep a daily diary of their symptoms. People with other skin conditions or diseases causing similar symptoms, significant bleeding risks, or severe health issues like heart disease are excluded.

Inclusion Criteria

You have had chronic hives for at least 6 months before the screening.

You have been experiencing itchiness and hives for at least 6 weeks, even though you have been taking a certain type of antihistamine.

You must be 18 years old or older to participate.

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Exclusion Criteria

You have other medical conditions that cause hives or swelling, like urticaria vasculitis, erythema multiforme, or mastocytosis.

You have a specific cause for your chronic hives, such as from physical triggers like pressure, cold, heat, or water.

You need to take blood-thinning medication like warfarin or NOACs.

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Treatment Details

Interventions

LOU064 (Bruton's Tyrosine Kinase (BTK) Inhibitor)
Placebo (Drug)

Trial OverviewThe trial is testing the effectiveness of Remibrutinib (LOU064), an investigational drug for CSU against a placebo. Participants will either receive the study drug in blinded conditions or open-label after initial phases, while their responses are compared to those receiving a non-active pill.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LOU064 25mg b.i.d.Experimental Treatment2 Interventions

Patients initially randomized to Remibrutinib during the Double-blind treatment period and continued Remibrutinib during the Open-label treatment period (Up to Week 52)

Group II: PlaceboPlacebo Group2 Interventions

Patients initially randomized to Placebo (Up to Week 24)