What side effects are associated with this type of intervention?

Common treatments for chronic urticaria include H1-antihistamines, corticosteroids, and biologics like omalizumab. H1-antihistamines can cause drowsiness, dry mouth, and dizziness. Corticosteroids may lead to weight gain, hypertension, and increased risk of infections with long-term use. Omalizumab, an anti-IgE antibody, can cause injection site reactions, headaches, and anaphylaxis in rare cases. For BTK inhibitors like Remibrutinib, potential side effects may include gastrointestinal issues, fatigue, and increased risk of infections, although specific data on Remibrutinib's side effects are still being studied.

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 biologic that has been approved for chronic spontaneous urticaria. It works by binding to IgE and preventing it from attaching to mast cells and basophils, thereby reducing the release of histamine and other inflammatory mediators. While Remibrutinib is a BTK inhibitor and represents a different class of medication, both aim to control the immune response involved in chronic urticaria.

What other types of research exist?

Promising, novel alternatives to Remibrutinib for Chronic Urticaria patients may include other BTK inhibitors or emerging biologic agents targeting different pathways involved in urticaria. Specific alternatives are not detailed in the provided context, so discussing with a healthcare provider for the latest clinical trial data and approved treatments is recommended.

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Remibrutinib for Chronic Urticaria (REMIX-2 Trial)

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

Common treatments for Chronic Urticaria (CU) include H1-antihistamines and emerging therapies like BTK inhibitors. H1-antihistamines work by blocking histamine receptors to reduce itching and swelling. However, for patients who do not respond adequately, BTK inhibitors such as Remibrutinib are being studied. These inhibitors block Bruton's tyrosine kinase, an enzyme crucial for the activation of immune cells that release histamine and other inflammatory mediators. By inhibiting this pathway, BTK inhibitors may offer significant relief for patients with CU inadequately controlled by standard antihistamines.

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 baseline up to 28 days after last dose of study medication, assessed up to approximately 56 weeks

Awards & highlights

Pivotal Trial

Summary

This trial is testing remibrutinib, a new medication, in adults with chronic hives not helped by standard allergy medicines. The medication works by blocking signals in the body that cause inflammation and allergic reactions.

Who is the study for?

Adults over 18 with chronic spontaneous urticaria (CSU) not well-managed by H1-antihistamines can join. They must have had CSU for at least 6 months, experienced itch and hives for more than 6 weeks despite treatment, and kept a diary of their symptoms. People with other skin conditions or serious health issues like heart disease, bleeding risks, or liver problems cannot participate.

What is being tested?

The trial is testing the effectiveness of Remibrutinib (LOU064), an investigational drug for CSU against a placebo. Participants will be randomly assigned to receive either the study drug or placebo in a blinded manner initially, followed by an open-label phase where everyone receives LOU064.

What are the potential side effects?

Possible side effects include reactions at the injection site, headaches, gastrointestinal issues like nausea or diarrhea, and potential allergic responses. The full range of side effects is unknown since this is part of what the study aims to discover.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 28 days after last dose of study medication, assessed up to approximately 56 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 28 days after last dose of study medication, assessed up to approximately 56 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 28 days after last dose of study medication, assessed 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

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

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

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

Secondary study objectives

Mean Cumulative Number of Angioedema Occurrence-free Weeks (AAS7 = 0 Response) up to Week 12

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

Number of Participants Who Achieved Complete Absence of Hives and Itch (UAS7 = 0) at Week 12

+4 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: LOU064 25mg b.i.d.Experimental Treatment2 Interventions

LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open- label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo)

Group II: PlaceboPlacebo Group2 Interventions

LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for 28 weeks. Randomised in 2:1 ratio (active vs placebo)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Remibrutinib

Not yet FDA approved

Remibrutinib

Not yet FDA approved

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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

Common treatments for Chronic Urticaria (CU) include H1-antihistamines and emerging therapies like BTK inhibitors. H1-antihistamines work by blocking histamine receptors to reduce itching and swelling. However, for patients who do not respond adequately, BTK inhibitors such as Remibrutinib are being studied. These inhibitors block Bruton's tyrosine kinase, an enzyme crucial for the activation of immune cells that release histamine and other inflammatory mediators. By inhibiting this pathway, BTK inhibitors may offer significant relief for patients with CU inadequately controlled by standard antihistamines.