Remibrutinib for Chronic Urticaria

(REMIX-1 Trial)

Recruiting at 144 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

470 Participants Needed

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.

Signed informed consent must be obtained prior to participation in the study.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: LOU064 25mg b.i.d. Experimental Treatment 2 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: Placebo Placebo Group 2 Interventions

Patients initially randomized to Placebo (Up to Week 24)

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

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD