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Remibrutinib for Chronic Urticaria (REMIX-1 Trial)
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 56 weeks
Awards & highlights
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 ~ 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Absolute change in ISS7 and absolute change in HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints)
Change from baseline in UAS7 (Scenario 1 with UAS7 as primary efficacy endpoint)
Secondary study objectives
Achievement of DLQI = 0 - 1
Change from baseline in UAS7 (only in scenario 2)
Complete absence of hives and itch (UAS7 = 0)
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: LOU064 (blinded)Experimental Treatment2 Interventions
LOU064 (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2).
Group II: Arm 2: LOU064 placebo (blinded)Placebo Group2 Interventions
LOU064 placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally for 28 weeks. Randomized in a 2:1 ratio (arm 1:arm 2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remibrutinib
Not yet FDA approved
Remibrutinib
Not yet FDA approved
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.
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Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,889 Previous Clinical Trials
4,201,534 Total Patients Enrolled
27 Trials studying Chronic Urticaria
8,669 Patients Enrolled for Chronic Urticaria
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have had serious bleeding in your stomach or intestines, possibly from taking certain pain medications like ibuprofen.You have a skin condition that causes long-term itching and could affect the study's evaluations and results, such as eczema, bullous pemphigoid, or psoriasis.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.You have a high risk of bleeding or have a blood clotting problem.You are taking certain blood thinning medications, except for a low dose of aspirin or clopidogrel. You cannot take both aspirin and clopidogrel together.You have a history of liver disease or your liver function tests show abnormal results.You must be 18 years old or older to participate.You have a serious health condition involving your heart, brain, mental health, lungs, kidneys, liver, hormones, blood, digestive system, or immune system that could make it unsafe for you to participate in the study.Your UAS7 score is 16 or higher, ISS7 score is 6 or higher, and HSS7 score is 6 or higher in the 7 days before the study starts.You have had hives in the three months before the study starts or have had them in the past.You had hives in the past three months before joining the study, or have a history of hives.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: LOU064 (blinded)
- Group 2: Arm 2: LOU064 placebo (blinded)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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