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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

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4

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

COVID-19

Headache

Eczema

COVID-19 pneumonia

Chest pain

Ovarian cyst

Tibia fracture

Melaena

Appendicitis

100%

80%

60%

40%

20%

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

~490

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,855 Previous Clinical Trials

4,197,206 Total Patients Enrolled

27 Trials studying Chronic Urticaria

8,980 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

Frequently Asked Questions

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

What potential risks are associated with the use of remibrutinib (LOU064)?

"The safety of LOU064 (remibrutinib) has been established at a 3 based on the findings from the current Phase 3 trial. There is evidence indicating its efficacy and several rounds of data that back its secure status."

Answered by AI

Are there still openings available to participate in this research study?

"Affirmative. Per the records posted on clinicaltrials.gov, this medical trial is actively enrolling new participants - an effort that began on April 5th 2023 and was most recently updated May 23rd 2023. The research requires 136 individuals from 24 distinct sites to participate in it."

Answered by AI

How many participants has this study attracted thus far?

"Affirmative, a review of clinicaltrials.gov suggests that this research is currently recruiting participants. This trial was initially posted on April 5th 2023 and the most recent update was made on May 23rd 2023. The study seeks to enroll 136 subjects from 24 separate medical facilities across the country."

Answered by AI

How many venues are offering access to this clinical experiment?

"This research project is actively recruiting from a total of 24 clinical sites. Aventura, Greenacres City and Boise are some of the locations participants can choose to be assessed at; however there are many other options as well. To minimize travel demands, it is suggested that patients make an appointment near their residence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.

2023. "A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05795153.

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