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Bruton's Tyrosine Kinase (BTK) Inhibitor

Remibrutinib for Chronic Urticaria

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
The presence of itch and hives for ≥6 consecutive weeks prior to screening despite the use of second generation H1-AH during this time period.
Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of baseline (Day 1) defined as:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4
Awards & highlights

Study Summary

This trial will assess the effects of a drug on blood pressure over 4 weeks, using a technique called ABPM recommended by the FDA.

Who is the study for?
Adults over 18 with chronic spontaneous urticaria (CSU) not well-controlled by antihistamines can join. They must have had itchy hives for at least 6 weeks despite treatment, and a certain severity score on their symptoms diary. People with specific triggers for their hives or past hypertension, those who've used BTK inhibitors like remibrutinib, or are sensitive to the study drug can't participate.Check my eligibility
What is being tested?
The trial is testing LOU064 (Remibrutinib), focusing on its effect on blood pressure in CSU patients inadequately controlled by H1-antihistamines. It aims to ensure that the drug doesn't raise average systolic blood pressure by more than 3mmHg after four weeks of treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be closely monitored for any increase in blood pressure as this is a known concern with some treatments for chronic conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have had itch and hives for over 6 weeks despite taking allergy medication.
Select...
My chronic hives are not controlled by standard allergy medications.
Select...
I have had chronic spontaneous urticaria for at least 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ambulatory blood pressure monitoring (ABPM) measurement

Side effects data

From 2022 Phase 2 trial • 229 Patients • NCT04109313
11%
Chronic spontaneous urticaria
8%
COVID-19
7%
Headache
5%
Eczema
1%
Tibia fracture
1%
Chest pain
1%
Ovarian cyst
1%
Melaena
1%
COVID-19 pneumonia
1%
Appendicitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treated Cohort (Treatment+Follow-up Period)
Treatment-free Cohort (Observational Period)

Trial Design

1Treatment groups
Experimental Treatment
Group I: LOU064 (remibrutinib)Experimental Treatment1 Intervention
Open label single arm trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOU064
2022
Completed Phase 3
~630

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,866 Previous Clinical Trials
4,199,182 Total Patients Enrolled
27 Trials studying Chronic Urticaria
8,996 Patients Enrolled for Chronic Urticaria

Media Library

LOU064 (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05795153 — Phase 3
Chronic Urticaria Research Study Groups: LOU064 (remibrutinib)
Chronic Urticaria Clinical Trial 2023: LOU064 Highlights & Side Effects. Trial Name: NCT05795153 — Phase 3
LOU064 (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05795153 — Phase 3
~66 spots leftby Jun 2025
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