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Bruton's Tyrosine Kinase (BTK) Inhibitor

Long-term Remibrutinib for Chronic Hives

Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male and female, adult participants ≥18 years of age.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 160 weeks
Awards & highlights

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.

Who is the study for?
This trial is for adults over 18 who have chronic spontaneous urticaria (hives) and completed previous Phase 3 studies with Remibrutinib. Participants must be able to follow the study plan and visit schedule. Those with significant bleeding risks, coagulation disorders, liver disease, or other serious health issues that could affect safety or results are not eligible.Check my eligibility
What is being tested?
The trial is testing the long-term effects of Remibrutinib on hives. It's an extension study for those who finished earlier trials with this drug. Some will receive Remibrutinib openly while others will get it without knowing if it's the actual drug or a placebo.See study design
What are the potential side effects?
While specific side effects aren't listed here, generally such drugs can cause reactions at injection sites, headaches, gastrointestinal issues like nausea or diarrhea, fatigue, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~160 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 160 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
Time to first composite event (i.e., relapse (UAS7≥16)
Secondary outcome measures
Number of participants with treatment-emergent (serious and non-serious) adverse events

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 3: LOU064 (Open Label)Experimental Treatment1 Intervention
LOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3)
Group II: Arm 1: LOU064 (blinded)Experimental Treatment2 Interventions
LOU064 (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
Group III: Arm 2: LOU064 Placebo (blinded)Placebo Group2 Interventions
LOU064 placebo (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOU064 (blinded)
2021
Completed Phase 3
~930

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,852 Previous Clinical Trials
4,196,724 Total Patients Enrolled
27 Trials studying Chronic Urticaria
8,103 Patients Enrolled for Chronic Urticaria

Media Library

LOU064 (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05513001 — Phase 3
Chronic Urticaria Research Study Groups: Arm 2: LOU064 Placebo (blinded), Arm 1: LOU064 (blinded), Arm 3: LOU064 (Open Label)
Chronic Urticaria Clinical Trial 2023: LOU064 Highlights & Side Effects. Trial Name: NCT05513001 — Phase 3
LOU064 (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05513001 — Phase 3

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
~681 spots leftby Jul 2027