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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
REMIX-1 Trial Summary
This trial will compare the effectiveness of a new drug, remibrutinib, to a placebo in adults with a chronic hives condition that isn't well controlled by existing medication.
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.Check my eligibility
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.See study design
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.
REMIX-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 56 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Achievement of DLQI = 0 - 1
Change from baseline in UAS7 (only in scenario 2)
Complete absence of hives and itch (UAS7 = 0)
+7 moreREMIX-1 Trial 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
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,880 Total Patients Enrolled
27 Trials studying Chronic Urticaria
8,654 Patients Enrolled for Chronic Urticaria
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has LOU064 (open-label) received FDA approval?
"LOU064 has received a safety score of 3 from our team at Power. This is because LOU064 is in Phase 3 trials, indicating that while there is data supporting efficacy, multiple rounds of testing have also shown it to be safe."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Email
Most responsive sites:
- Novartis Investigative Site: < 48 hours
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