What side effects are associated with this type of intervention?

Common treatments for chronic urticaria include H1-antihistamines, corticosteroids, and biologics like omalizumab. For treatments similar to Remibrutinib, which is a BTK inhibitor, side effects can include headache, nausea, diarrhea, and increased risk of infections. Other potential side effects may include liver enzyme abnormalities and hypertension. It is important to discuss these with a healthcare provider to understand the risks and benefits.

What prior FDA approvals exist?

The FDA has approved several treatments for chronic urticaria, particularly for cases inadequately controlled by H1-antihistamines. Omalizumab, an anti-IgE antibody, is one such treatment that has shown efficacy in chronic spontaneous urticaria (CSU). While Remibrutinib is a BTK inhibitor, which is a different class of drug, both aim to manage symptoms in patients who do not respond to standard antihistamine therapy. Other treatments include leukotriene receptor antagonists like montelukast, though their efficacy in CSU is less established compared to omalizumab.

What other types of research exist?

Promising novel alternatives to Remibrutinib for Chronic Urticaria patients may include other BTK inhibitors under investigation, as well as biologic agents targeting different pathways involved in urticaria. Examples include omalizumab (an anti-IgE antibody) and emerging biologics targeting interleukins such as IL-4, IL-5, and IL-13. Consulting with a healthcare provider for the latest clinical trial data and approved treatments is recommended.

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Remibrutinib for Chronic Urticaria (REMIX-1 Trial)

Q: What is the mechanism of action of this treatment?

Chronic Urticaria (CU) is commonly treated with H1-antihistamines, which block histamine receptors to reduce itching and swelling. For patients inadequately controlled by antihistamines, treatments like omalizumab, a monoclonal antibody, target and inhibit IgE, reducing allergic responses. Remibrutinib, a BTK inhibitor, works by blocking Bruton's tyrosine kinase, which plays a crucial role in the activation of immune cells involved in allergic reactions. This inhibition can reduce the severity and frequency of urticaria symptoms. Understanding these mechanisms is vital for CU patients as it helps tailor treatments to effectively manage their symptoms and improve their quality of life.

Phase 3

Waitlist Available

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on-treatment adverse events are reported from first dose of study medication up to 28 days after last dose of study medication, for a timeframe up to approximately 56 weeks

Awards & highlights

Pivotal Trial

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones may include reactions at the injection site, headaches, gastrointestinal issues like nausea or diarrhea, potential liver enzyme changes and possibly increased risk of infections due to immune system effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on-treatment adverse events are reported from first dose of study medication up to 28 days after last dose of study medication, for a timeframe up to approximately 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on-treatment adverse events are reported from first dose of study medication up to 28 days after last dose of study medication, for a timeframe up to approximately 56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and on-treatment adverse events are reported from first dose of study medication up to 28 days after last dose of study medication, for a timeframe up to approximately 56 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Weekly Hives Severity Score (HSS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)

Change From Baseline in Weekly Itch Severity Score (ISS7) at Week 12 (Scenario 2 With ISS7 and HSS7 as Co-primary Efficacy Endpoints)

Change From Baseline in Weekly Urticaria Score (UAS7) at Week 12 (Scenario 1 With UAS7 as Primary Efficacy Endpoint)

Secondary study objectives

Cumulative Number of Weeks With Disease Activity Control (UAS7 <= 6) up to Week 12

Cumulative Number of Weeks Without Angioedema (AAS7 = 0)

Number of Participants With Adverse Events

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LOU064 25 mg (b.i.d)

2021

Completed Phase 3

~470

LOU064 25 mg (b.i.d) as a tablet.

2021

Completed Phase 3

~470

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Chronic Urticaria (CU) is commonly treated with H1-antihistamines, which block histamine receptors to reduce itching and swelling. For patients inadequately controlled by antihistamines, treatments like omalizumab, a monoclonal antibody, target and inhibit IgE, reducing allergic responses. Remibrutinib, a BTK inhibitor, works by blocking Bruton's tyrosine kinase, which plays a crucial role in the activation of immune cells involved in allergic reactions. This inhibition can reduce the severity and frequency of urticaria symptoms. Understanding these mechanisms is vital for CU patients as it helps tailor treatments to effectively manage their symptoms and improve their quality of life.