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Remibrutinib for Chronic Urticaria (REMIX-2 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
CSU duration for ≥ 6 months prior to screening (defined as the onset of CSU determined by the investigator based on all available supporting documentation).
Diagnosis of CSU inadequately controlled by second generation H1-antihistamines 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-antihistamines during this time period
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 weeks
Awards & highlights

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.

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.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 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.See study design
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.

REMIX-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have had chronic hives for at least 6 months before the screening.
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You have been experiencing itching and hives for at least 6 weeks, even though you've been taking second-generation H1-antihistamines.

REMIX-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 weeks for reporting.

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 an 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 more

REMIX-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: LOU064 (blinded)Experimental Treatment2 Interventions
LOU064A (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally open label for 28 weeks. Randomised in 2:1 ratio (active vs placebo)
Group II: Arm 2: LOU064 placebo (blinded)Placebo Group2 Interventions
LOU064A placebo (blinded) taken orally for 24 weeks, followed by LOU064 (open-label) taken orally open label 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

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,197,134 Total Patients Enrolled
27 Trials studying Chronic Urticaria
8,669 Patients Enrolled for Chronic Urticaria

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT05032157 — Phase 3
Chronic Urticaria Research Study Groups: Arm 1: LOU064 (blinded), Arm 2: LOU064 placebo (blinded)
Chronic Urticaria Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT05032157 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT05032157 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

Who else is applying?

What state do they live in?
Florida
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~140 spots leftby Mar 2025