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Remibrutinib for Chronic Urticaria

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
Cholinergic Urticaria: A physician global assessment of severity of hives ≥ 2 using the Pulse-controlled ergometry test and a numerical rating scale score of ≥5 for itch after the provocation test.
Symptomatic Dermographism: A Total Fric Score of ≥3 using the FricTest® 4.0 and a numerical rating scale score of ≥5 for itch after the provocation test.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 52
Awards & highlights
Pivotal Trial

Summary

This trial tests if a drug (remibrutinib) can help adults with CINDU, a condition inadequately controlled by antihistamines. Results will show safety, efficacy, & tolerability.

Who is the study for?
Adults over 18 with Chronic Inducible Urticaria (CINDU) not well-managed by antihistamines can join. They must have a confirmed CINDU diagnosis for at least 4 months and meet specific test criteria showing their condition's severity.
What is being tested?
The trial is testing Remibrutinib against a placebo in adults with CINDU. It's double-blind, meaning neither the patients nor doctors know who gets what treatment. After 52 weeks, there's an option to enter a long-term study phase.
What are the potential side effects?
While the side effects of Remibrutinib are not detailed here, common ones may include reactions at the injection site, headaches, gastrointestinal issues, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My doctor says my hives are moderate to severe, and I feel a lot of itchiness.
Select...
I have severe skin writing with itching scored high on a specific test.
Select...
I have been diagnosed with a chronic skin condition for over 4 months and treatments haven't worked well.
Select...
I sweat during exercise tests and do not have a condition stopping me from sweating.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of participants with complete response in Total Fric Score; symptomatic dermographism
Proportion of participants with complete response in critical temperature threshold; cold urticaria
Proportion of participants with itch numerical rating scale =0; cholinergic urticaria
Secondary study objectives
Change from baseline in Critical Temperature Threshold in participants with cold urticaria
Change from baseline in TFS in participants with symptomatic dermographism
Change from baseline in Total Fric score; symptomatic dermographism
+18 more

Side effects data

From 2024 Phase 3 trial • 470 Patients • NCT05030311
5%
COVID-19
5%
Nasopharyngitis
3%
Influenza
2%
Diarrhoea
2%
Upper respiratory tract infection
2%
Arthralgia
2%
Headache
2%
Petechiae
2%
Urticaria
1%
Abortion spontaneous
1%
Pyrexia
1%
Urinary tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Transitioned to LOU064 25mg b.i.d.
LOU064 25mg b.i.d.
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Remibrutinib, symptomatic dermographism groupExperimental Treatment1 Intervention
Remibrutinib oral twice daily in participants with symptomatic dermographism
Group II: Remibrutinib, cold urticaria groupExperimental Treatment1 Intervention
Remibrutinib oral twice daily, cold urticaria
Group III: Remibrutinib, cholinergic urticaria groupExperimental Treatment1 Intervention
Remibrutinib oral twice daily, cholinergic urticaria
Group IV: Placebo, cholinergic urticariaPlacebo Group1 Intervention
Placebo oral twice daily, cholinergic urticaria
Group V: Placebo, cold urticaria groupPlacebo Group1 Intervention
Placebo oral twice daily, cold urticaria
Group VI: Placebo, symptomatic dermographism groupPlacebo Group1 Intervention
Placebo oral twice daily, symptomatic dermographism

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,919 Previous Clinical Trials
4,254,159 Total Patients Enrolled
28 Trials studying Chronic Urticaria
8,816 Patients Enrolled for Chronic Urticaria
~209 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
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