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Remibrutinib for Chronic Urticaria (REMIX-2 Trial)
REMIX-2 Trial Summary
This trial will compare the effects of remibrutinib to placebo in adults with CSU that is not well controlled by H1-antihistamines.
REMIX-2 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREMIX-2 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REMIX-2 Trial Design
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Who is running the clinical trial?
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- You are male or female and at least 18 years of age.You have been experiencing chronic hives for at least 6 months before the screening.You have had hives in the past three months before being chosen for the study, or they are part of your medical history.You have experienced itchiness and hives for at least six weeks, even after taking a certain type of medication for it.You have a specific cause for your chronic urticaria, such as hives triggered by physical stimuli like pressure, cold, heat, or water.You have had chronic hives for at least 6 months before the screening.You have a history of liver disease or your liver enzyme levels are higher than normal.Your UAS7 score is 16 or higher, your ISS7 score is 6 or higher, and your HSS7 score is 6 or higher in the 7 days before starting the study.You have a high risk of bleeding or blood clotting problems.You have a history of serious stomach bleeding, especially caused by taking certain pain medications.You need to take medication to prevent blood clots, but you can only take a low dose of aspirin or clopidogrel. Taking both aspirin and clopidogrel together is not allowed.You have other diseases with symptoms of hives or swelling.You have a skin condition with chronic itching that could affect the study's evaluations and results, such as eczema, bullous pemphigoid, or psoriasis.You need to take blood-thinning medication like warfarin or NOACs.You have been experiencing itching and hives for at least 6 weeks, even though you've been taking second-generation H1-antihistamines.Your skin condition scores are higher than a certain number in the 7 days before starting the study.You have had hives in the three months before the start of the study.You have a history of serious heart, brain, mental health, lung, kidney, liver, hormone, blood, stomach, or immune system problems that could affect your safety in the study, make it hard to understand the study results, or prevent you from following the study's plan.
- Group 1: Arm 1: LOU064 (blinded)
- Group 2: Arm 2: LOU064 placebo (blinded)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
How many medical clinics are conducting this study?
"Currently, this trial is being conducted at 48 different sites. These locations include Farmington, Orlando and Mayfield Heights but are not limited to these places. If you enroll in the trial, it would be advantageous to choose a location near you to cut down on travel time and expenses."
Has the Food and Drug Administration cleared LOU064 for use?
"LOU064 (open-label) has received a score of 3 for safety. This is due to being in Phase 3, meaning that there is efficacy data as well as multiple rounds of safe data supporting it."
How many people have signed up to participate in this clinical trial thus far?
"That is correct, according to the information available on clinicaltrials.gov this study is still enrolling patients. The original posting date was December first 2021 and the most recent edit was done on July 14th, 2022. In total, the researchers are hoping to find 450 participants spread out across 48 different locations."
Are people still able to sign up for this research project?
"That is accurate. The information available on clinicaltrials.gov indicates that this study, which was first announced on December 1st 2021, is still looking for enrollees. In total, they need 450 patients from 48 different locations to participate."
What is the purpose of this research?
"The primary objective of this 12-week trial is to assess the absolute change in ISS7 and HSS7 (Scenario 2 with ISS7 and HSS7 as co-primary efficacy endpoints). Secondary objectives include demonstrating that a greater proportion of participants who are treated with remibrutinib achieve DLQI = 0-1 at Week 12 compared to placebo-treated participants, reducing the weekly HSS score (only in scenario 1), and demonstrating that a greater proportion of participants achieve disease activity control (UAS7 ≤ 6) at Week 12 who are treated with remibrutinib compared to placebo-treated"
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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