470 Participants Needed

Remibrutinib for Chronic Urticaria

(REMIX-1 Trial)

Recruiting at 144 trial locations
NP
Overseen ByNovartis Pharmaceuticals
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Novartis Pharmaceuticals
Must be taking: H1-antihistamines
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

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

NP

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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.
Signed informed consent must be obtained prior to participation in the study.
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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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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Double-blind placebo-controlled treatment

Participants receive either remibrutinib or placebo in a double-blind manner

24 weeks

Open-label treatment

Participants receive remibrutinib in an open-label manner

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LOU064
  • Placebo
Trial Overview The 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LOU064 25mg b.i.d.Experimental Treatment2 Interventions
Group II: PlaceboPlacebo Group2 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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