Remibrutinib for Hives
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called remibrutinib for individuals with chronic hives, a condition that causes red, itchy welts on the skin. The study aims to determine the effectiveness of remibrutinib and its effects on the body compared to a placebo (a non-active treatment). Participants will be divided into groups, with some receiving remibrutinib and others a placebo. The trial seeks participants who have had chronic hives not well-controlled by standard allergy medications for at least four months. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, certain medications like other investigational drugs, dual anti-platelet therapy, and anticoagulants are prohibited. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that remibrutinib is likely to be safe for humans?
Research has shown that remibrutinib is safe for treating both Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU). Studies indicate that patients generally tolerate this treatment well, even with long-term use.
For CSU, remibrutinib provided quick symptom relief and maintained safety over time. Most patients did not experience serious side effects, and the treatment remained consistently safe for up to 52 weeks.
In CINDU, remibrutinib also demonstrated safety, with patients experiencing few adverse effects.
Overall, research supports remibrutinib as a safe option for individuals with these types of hives.12345Why do researchers think this study treatment might be promising for hives?
Remibrutinib is unique because it targets Bruton's tyrosine kinase (BTK), a key player in the immune system that contributes to excessive inflammation. Most treatments for chronic urticaria, like antihistamines and omalizumab, focus on blocking histamine or other inflammatory pathways after they've been activated. However, Remibrutinib works upstream by inhibiting BTK, potentially reducing the inflammation driving the hives. Researchers are excited because this could mean better control of symptoms with fewer side effects and improved effectiveness for patients whose conditions aren't well-managed by existing options.
What evidence suggests that remibrutinib might be an effective treatment for chronic urticaria?
Research has shown that remibrutinib, which participants in this trial may receive, may effectively treat both types of chronic hives. For Chronic Inducible Urticaria (CINDU), remibrutinib ranks among the most effective treatments and is generally safe. In cases of Chronic Spontaneous Urticaria (CSU), patients experienced significant relief from itching and hives as early as the first week of treatment. This relief persisted over time, maintaining a good safety record. Overall, remibrutinib offers a promising option for those dealing with these challenging skin conditions.12346
Are You a Good Fit for This Trial?
This trial is for individuals with Chronic Urticaria, including both spontaneous and inducible types. Participants must have had symptoms for at least 6 months, score high on urticaria severity scales, and be able to attend all study procedures. Those who can't commit or don't meet the symptom severity criteria cannot join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive remibrutinib or placebo for 12 weeks
End of Study Visit
Participants have an end of study visit approximately 7 days after the last dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Remibrutinib
Trial Overview
The study is testing Remibrutinib (LOU064), a potential new treatment for chronic urticaria against a placebo. It aims to assess its effectiveness in improving clinical outcomes and understand how it works in patients with this condition.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled
Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms.
Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms.
Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled
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Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD
Citations
NCT06865651 | Study of Remibrutinib (LOU064) Efficacy ...
The purpose of this study is to explore the effect and Mechanism of Action (MoA) of remibrutinib (LOU064) vs. placebo on clinical outcomes in participants ...
A Study to Investigate Efficacy, Safety, and Tolerability of ...
This study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by ...
New insights into chronic inducible urticaria - PMC
CIndU is a hard-to-treat and long lasting skin disorder that highly impairs QoL of affected patients. Provocation tests allow to diagnose CIndU ...
Systematic review and network meta-analysis
Standard-dose omalizumab and remibrutinib are among the most effective drugs across multiple patient-important outcomes with a favorable safety profile across ...
NCT05976243 | A Study to Investigate Efficacy, Safety, and ...
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE).
ANZCTR - Registration
* 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 ...
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