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Long-term Remibrutinib for Chronic Hives
Study Summary
This trial will investigate long-term effects of Remibrutinib on people with chronic hives. It will also provide access to those who participated in past trials.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I need medication to prevent blood clots.I do not have major health issues that would affect my safety or participation in the study.I have a high risk of bleeding or a blood clotting disorder.You have finished the previous main studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304, or CLOU064A2305 as per the rules.I am on medication to prevent blood clots.I have a history of liver disease.I have had bleeding in my stomach or intestines.I am 18 years old or older.
- Group 1: Arm 2: LOU064 Placebo (blinded)
- Group 2: Arm 1: LOU064 (blinded)
- Group 3: Arm 3: LOU064 (Open Label)
- 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
Has the FDA given its authorization for Arm 3: LOU064 (Open Label)?
"Our evaluation at Power assigned Arm 3: LOU064 (Open Label) a rating of 3 due to its Phase 3 status, which indicates that there is existing evidence for both effectiveness and safety."
How many centers are managing this clinical trial?
"Currently, the medical research is being conducted across 65 different sites. Patients in Bakersfield, Lancaster and Denver have access to a nearby trial centre; however those further away should select their closest location to reduce travel needs when they join the study."
What is the scope of participants included in this clinical investigation?
"Affirmative. Data from clinicaltrials.gov demonstrates that this research endeavour, which was initiated on December 9th 2022, is actively seeking participants to enrol in the trial. 1021 subjects are required for the study and can be recruited from 65 distinct medical facilities."
Can patient participants still join this research endeavor?
"Affirmative. According to information on clinicaltrials.gov, this experiment is currently seeking test subjects; it was first posted in December of 2022 and the most recent update occurred in April of 2023. The trial requires 1021 individuals from 65 different venues for recruitment."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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