Remibrutinib for Chronic Urticaria

(REMIX-1 Trial)

No longer recruiting at 170 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must be taking: H1-antihistamines

Must not be taking: Anticoagulants, Dual anti-platelet

Disqualifiers: Cardiovascular, Neurological, Psychiatric, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

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 spontaneous urticaria (CSU), a condition causing persistent itchy hives that do not respond to regular allergy medicine. Researchers aim to determine if remibrutinib is safe and more effective than a placebo (a pill with no active medicine) for those whose CSU remains uncontrolled by standard treatments. Suitable participants have experienced frequent hives and itching for at least six months, even while taking second-generation antihistamines. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants an opportunity to contribute to the development of a promising new treatment.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot participate if you require certain anti-platelet or anticoagulant medications. 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, the treatment under study for chronic spontaneous urticaria (CSU), appears safe. In earlier studies, patients with CSU tolerated remibrutinib well and experienced quick relief from symptoms like itching and hives, common in this condition.

The treatment is now in a later stage of clinical trials, indicating it has already passed initial safety tests. Most participants in these studies did not experience serious side effects, suggesting that remibrutinib could be a safe option for those who haven't found relief with other treatments.

For those considering joining a clinical trial for remibrutinib, these findings may clarify its safety. Always consult a healthcare provider to make an informed decision. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic urticaria?

Remibrutinib is unique because it targets a specific protein called Bruton's tyrosine kinase (BTK), which plays a key role in the immune response leading to chronic urticaria, or hives. Unlike standard treatments for chronic urticaria that primarily focus on antihistamines or corticosteroids, Remibrutinib works at the cellular level to directly inhibit the activity of BTK, potentially reducing inflammation and the frequency of hives more effectively. Researchers are excited about Remibrutinib because it offers a novel approach that could provide relief for patients who do not respond well to existing therapies. Additionally, its oral administration makes it a convenient option compared to some other treatments that require injections.

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 help treat chronic spontaneous urticaria (CSU), a condition that causes itching and hives. In earlier studies, patients experienced significant improvement in their symptoms by week 12. This improvement was measured using the weekly urticaria activity score (UAS7), which decreased significantly compared to those taking a placebo (a pill with no active medicine). Some patients even felt better as early as the first week. This suggests that remibrutinib could benefit individuals whose CSU isn't well-managed by standard allergy medicines like H1-antihistamines. ^{1 2 4 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

Adults over 18 with chronic spontaneous urticaria (CSU) not well-managed by H1-antihistamines can join this trial. They must have had CSU for at least 6 months, experience itch and hives despite current treatment, and be able to keep a daily diary of their symptoms. People with other skin conditions or diseases causing similar symptoms, significant bleeding risks, or severe health issues like heart disease are excluded.

Inclusion Criteria

You have had chronic hives for at least 6 months before the screening.

You have been experiencing itchiness and hives for at least 6 weeks, even though you have been taking a certain type of antihistamine.

Signed informed consent must be obtained prior to participation in the study.

Exclusion Criteria

You have other medical conditions that cause hives or swelling, like urticaria vasculitis, erythema multiforme, or mastocytosis.

You have a specific cause for your chronic hives, such as from physical triggers like pressure, cold, heat, or water.

You need to take blood-thinning medication like warfarin or NOACs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Double-blind placebo-controlled treatment

Participants receive either remibrutinib or placebo in a double-blind manner

24 weeks

Open-label treatment

Participants receive remibrutinib in an open-label manner

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LOU064
• Placebo

Trial Overview The trial is testing the effectiveness of Remibrutinib (LOU064), an investigational drug for CSU against a placebo. Participants will either receive the study drug in blinded conditions or open-label after initial phases, while their responses are compared to those receiving a non-active pill.

How Is the Trial Designed?

Group I: LOU064 25mg b.i.d. Experimental Treatment 2 Interventions

Patients initially randomized to Remibrutinib during the Double-blind treatment period and continued Remibrutinib during the Open-label treatment period (Up to Week 52)

Group II: Placebo Placebo Group 2 Interventions

Patients initially randomized to Placebo (Up to Week 24)

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

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

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41005705/

A Systematic Review and Meta-Analysis Results: In the pooled analysis of RCTs, remibrutinib effectively decreased UAS7 at Week 12 compared to placebo (MD -7.81, 95% CI: -10.29 to - ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40043237/

Remibrutinib in Chronic Spontaneous Urticaria Treatment with oral remibrutinib resulted in a significant improvement in a composite measure of itching and hives at week 12.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06865651

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 ...

4. nejm.org nejm.org/doi/abs/10.1056/NEJMoa2408792

Remibrutinib in Chronic Spontaneous Urticaria Treatment with oral remibrutinib resulted in a significant improvement in a composite measure of itching and hives at week 12.

5. novartis.com novartis.com/news/media-releases/novartis-phase-iii-data-confirm-sustained-efficacy-and-long-term-safety-oral-remibrutinib-chronic-spontaneous-urticaria

Novartis Phase III data confirm sustained efficacy and long- ... Patients treated with remibrutinib experienced improvements in weekly urticaria activity scores (UAS7) observed as early as Week 1 and ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825009171

Efficacy, Safety, and Quality-of-Life Outcomes ... Efficacy, Safety, and Quality-of-Life Outcomes of Remibrutinib in Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis.

7. novartis.com novartis.com/clinicaltrials/study/nct06865651

Study of Remibrutinib (LOU064) Efficacy and Safety ... 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 with ...