What side effects are associated with this type of intervention?

Common treatments for Chronic Urticaria include antihistamines, corticosteroids, and biologics such as omalizumab. For BTK inhibitors like Remibrutinib, side effects may include headache, nausea, diarrhea, and upper respiratory tract infections. Other potential side effects can include fatigue, dizziness, and increased risk of infections due to immune system modulation. 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, including antihistamines, omalizumab (an anti-IgE antibody), and corticosteroids. Omalizumab, in particular, is a biologic agent that has shown efficacy in patients with Chronic Spontaneous Urticaria who do not respond to antihistamines. While specific information on prior FDA approvals of BTK inhibitors like Remibrutinib for Chronic Urticaria is not available, the focus on biologic agents and targeted therapies represents a similar approach in managing the condition.

What other types of research exist?

Promising novel alternatives to Remibrutinib for Chronic Urticaria patients include biologic agents such as omalizumab, which targets IgE, and other emerging therapies like ligelizumab, another anti-IgE monoclonal antibody. Additionally, Janus kinase (JAK) inhibitors, such as ritlecitinib and brepocitinib, have shown potential in treating autoimmune conditions and may be considered for Chronic Urticaria.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

Long-term Remibrutinib for Chronic Hives

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

Must not have

Requirement for anti-platelet medication.

Significant bleeding risk or coagulation disorders.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 160 weeks

Awards & highlights

Pivotal Trial

Summary

This trial tests remibrutinib, a medication for adults with chronic hives not helped by standard treatments. It aims to see if remibrutinib can reduce symptoms by blocking signals that cause hives. Remibrutinib is a highly selective, oral medication that has shown promising efficacy and safety in treating chronic spontaneous urticaria.

Who is the study for?

This trial is for adults over 18 who have chronic spontaneous urticaria (hives) and completed previous Phase 3 studies with Remibrutinib. Participants must be able to follow the study plan and visit schedule. Those with significant bleeding risks, coagulation disorders, liver disease, or other serious health issues that could affect safety or results are not eligible.

What is being tested?

The trial is testing the long-term effects of Remibrutinib on hives. It's an extension study for those who finished earlier trials with this drug. Some will receive Remibrutinib openly while others will get it without knowing if it's the actual drug or a placebo.

What are the potential side effects?

While specific side effects aren't listed here, generally such drugs can cause reactions at injection sites, headaches, gastrointestinal issues like nausea or diarrhea, fatigue, and potential allergic responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need medication to prevent blood clots.

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I have a high risk of bleeding or a blood clotting disorder.

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I am on medication to prevent blood clots.

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I have a history of liver disease.

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I have had bleeding in my stomach or intestines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 160 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~160 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 160 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

Time to first composite event (i.e., relapse (UAS7≥16)

Secondary study objectives

Number of participants with treatment-emergent (serious and non-serious) adverse events

Awards & Highlights

Pivotal Trial

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

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm 3: LOU064 (Open Label)Experimental Treatment1 Intervention

LOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3)

Group II: Arm 1: LOU064 (blinded)Experimental Treatment2 Interventions

LOU064 (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)

Group III: Arm 2: LOU064 Placebo (blinded)Placebo Group2 Interventions

LOU064 placebo (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LOU064 (blinded)

2021

Completed Phase 3

~930

0 / 5Eligibility criteria met

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) treatments primarily aim to reduce symptoms by targeting different pathways involved in the inflammatory response. BTK inhibitors like Remibrutinib work by blocking Bruton's tyrosine kinase, which plays a crucial role in the activation of immune cells that release histamine and other inflammatory mediators. This helps in reducing the severity and frequency of hives and itching. Antihistamines, the first-line treatment, block histamine receptors to prevent histamine from causing symptoms. Omalizumab, an anti-IgE antibody, reduces the levels of free IgE, thereby decreasing the activation of mast cells and basophils. Corticosteroids suppress the overall immune response, providing relief from severe symptoms. Understanding these mechanisms is vital for CU patients as it helps in selecting the most appropriate treatment based on the severity and underlying causes of their condition.