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, nasopharyngitis, nausea, and increased risk of infections. Other potential side effects may include fatigue, diarrhea, and elevated liver enzymes. It is important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

Currently, there are no specific mentions of FDA-approved Bruton's Tyrosine Kinase (BTK) inhibitors for the treatment of chronic urticaria. However, other targeted therapies, such as omalizumab, an anti-IgE antibody, have been approved for chronic spontaneous urticaria in patients who remain symptomatic despite H1-antihistamine treatment. Omalizumab works by binding to IgE, reducing the allergic response that can lead to urticaria symptoms.

What other types of research exist?

Promising novel alternatives to Remibrutinib for Chronic Urticaria patients include Janus Kinase (JAK) inhibitors such as Ruxolitinib and other emerging biologics targeting different pathways involved in urticaria. These alternatives have shown potential in clinical trials for their efficacy and safety profiles.

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Bruton's Tyrosine Kinase (BTK) Inhibitor

LOU064 for Chronic Urticaria

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

The most common treatments for Chronic Urticaria (CU) include H1-antihistamines, corticosteroids, and biologics like omalizumab. H1-antihistamines work by blocking histamine receptors, reducing itching and swelling. Corticosteroids suppress the immune response, decreasing inflammation. Omalizumab, an anti-IgE antibody, binds to IgE, preventing it from triggering allergic reactions. Remibrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, targets BTK, a key enzyme in the signaling pathways of immune cells, thereby reducing the release of inflammatory mediators. This is particularly important for CU patients as it offers a targeted approach to control symptoms that are inadequately managed by conventional treatments.

Phase 3

Recruiting

Research Sponsored by Novartis Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Diagnosis of CSU inadequately controlled by second-generation H1-AH at the time of randomization defined as: The presence of itch and hives for ≥ 6 consecutive weeks prior to screening despite the use of second-generation H1-AH during this time period according to local treatment guidelines

Male and female adolescent participants aged ≥ 12 to < 18 years of age at the time of screening

Must not have

Requirement for anti-platelet medication, except for acetylsalicylic acid up to 100 mg/d or clopidogrel up to 75 mg/d. The use of dual anti-platelet therapy (e.g., acetylsalicylic acid + clopidogrel) is prohibited

History or current hepatic disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Pivotal Trial

Summary

This trial tests remibrutinib in teenagers with chronic hives not helped by standard treatments. The medication aims to reduce hives and itching by blocking signals that cause these symptoms.

Who is the study for?

Adolescents aged 12 to under 18 with chronic spontaneous urticaria (hives) not well-controlled by antihistamines can join. They must have had hives for at least six months and show certain scores on itch and hive severity scales. Those with liver disease, other skin conditions causing itching, or a history of severe allergic reactions to similar drugs cannot participate.

What is being tested?

The trial is testing the effectiveness of LOU064 (remibrutinib), a medication against placebo in adolescents who haven't responded well to antihistamines for their chronic hives. It includes an initial 24-week double-blind phase followed by up to three years where all participants may receive remibrutinib.

What are the potential side effects?

Possible side effects are not explicitly listed but typically include reactions related to the immune system, digestive issues, and potential risks associated with long-term use which will be monitored over the course of treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chronic hives and itching for over 6 weeks despite taking allergy medication.

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I am between 12 and 17 years old.

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I have had chronic spontaneous urticaria for 6 months or more.

Exclusion Criteria

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

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I only take low-dose aspirin or clopidogrel for my heart.

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I have a history of liver disease.

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I have had bleeding in my stomach or intestines before.

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

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I have previously used remibrutinib or other BTK inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years 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 HSS7

Change from baseline in UAS7

Change fron baseline in ISS7

Secondary study objectives

AUClast of remibrutinib

Absolute change from baseline in CDLQI score

Absolute change from baseline in HSS7

+8 more

Side effects data

From 2024 Phase 3 trial • 455 Patients • NCT05032157

21%

COVID-19

11%

Nasopharyngitis

Upper respiratory tract infection

Headache

Suspected COVID-19

Petechiae

Urinary tract infection

Urticaria

Influenza

Lipase increased

Hyperuricaemia

Arthralgia

Sinusitis

Hyperlipidaemia

100%

80%

60%

40%

20%

Study treatment Arm

LOU064 25 mg b.i.d.

Placebo

Transitioned to LOU064 25 mg b.i.d.

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: Arm 1: LOU064 (blinded)Experimental Treatment1 Intervention

LOU064 (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for up to 6 cycles of 24 weeks.

Group II: Arm 2: LOU064 placebo (blinded)Placebo Group1 Intervention

LOU064 placebo (blinded) taken orally b.i.d. for 24 weeks (randomized in a 2:1 ratio arm 1: arm 2)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LOU064 (blinded)

2021

Completed Phase 3

~460

0 / 8Eligibility 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

The most common treatments for Chronic Urticaria (CU) include H1-antihistamines, corticosteroids, and biologics like omalizumab. H1-antihistamines work by blocking histamine receptors, reducing itching and swelling. Corticosteroids suppress the immune response, decreasing inflammation. Omalizumab, an anti-IgE antibody, binds to IgE, preventing it from triggering allergic reactions. Remibrutinib, a Bruton's Tyrosine Kinase (BTK) inhibitor, targets BTK, a key enzyme in the signaling pathways of immune cells, thereby reducing the release of inflammatory mediators. This is particularly important for CU patients as it offers a targeted approach to control symptoms that are inadequately managed by conventional treatments.