~32 spots leftby Nov 2025

LOU064 for Chronic Urticaria

Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Novartis Pharmaceuticals
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests remibrutinib in teenagers with chronic hives not helped by standard treatments. The medication aims to reduce hives and itching by blocking signals that cause these symptoms.
Is the drug LOU064 (Remibrutinib) a promising treatment for chronic urticaria?Yes, LOU064 (Remibrutinib) is a promising drug for chronic urticaria. It has shown a favorable safety profile and sustained effectiveness over 52 weeks, providing fast disease control for patients who do not respond to standard antihistamine treatments.12469
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. However, you cannot use dual anti-platelet therapy, and certain medications like remibrutinib or other BTK inhibitors are not allowed. It's best to discuss your specific medications with the trial team.
What safety data is available for Remibrutinib in treating chronic urticaria?Remibrutinib (LOU064) has demonstrated a favorable safety profile in treating chronic spontaneous urticaria over a 52-week period. It is a highly selective Bruton tyrosine kinase inhibitor and is currently in phase 3 development for this condition. The treatment has shown promising efficacy and safety in clinical trials.23789
What data supports the idea that LOU064 for Chronic Urticaria is an effective drug?The available research shows that LOU064, also known as Remibrutinib, is effective for treating chronic urticaria. It offers fast disease control for patients who do not respond to other treatments like second-generation H1 antihistamines. Over a period of 52 weeks, it has shown a favorable safety profile and sustained effectiveness. Compared to another treatment, Omalizumab, which is also effective, Remibrutinib is highlighted for its promising results in controlling symptoms and improving the quality of life for patients with chronic spontaneous urticaria.23579

Eligibility Criteria

Adolescents aged 12 to under 18 with chronic spontaneous urticaria (hives) not well-controlled by antihistamines can join. They must have had hives for at least six months and show certain scores on itch and hive severity scales. Those with liver disease, other skin conditions causing itching, or a history of severe allergic reactions to similar drugs cannot participate.

Inclusion Criteria

I have chronic hives and itching for over 6 weeks despite taking allergy medication.
I am between 12 and 17 years old.
I have had chronic spontaneous urticaria for 6 months or more.

Exclusion Criteria

I only take low-dose aspirin or clopidogrel for my heart.
I have a history of liver disease.
I have had bleeding in my stomach or intestines before.
I have a high risk of bleeding or a blood clotting disorder.
I have previously used remibrutinib or other BTK inhibitors.

Treatment Details

The trial is testing the effectiveness of LOU064 (remibrutinib), a medication against placebo in adolescents who haven't responded well to antihistamines for their chronic hives. It includes an initial 24-week double-blind phase followed by up to three years where all participants may receive remibrutinib.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm 1: LOU064 (blinded)Experimental Treatment1 Intervention
LOU064 (blinded) taken orally b.i.d. for 24 weeks, followed by LOU064 (open-label) taken orally b.i.d. for up to 6 cycles of 24 weeks.
Group II: Arm 2: LOU064 placebo (blinded)Placebo Group1 Intervention
LOU064 placebo (blinded) taken orally b.i.d. for 24 weeks (randomized in a 2:1 ratio arm 1: arm 2)

Find a clinic near you

Research locations nearbySelect from list below to view details:
Allergy Asthma and Clinical ResearchOklahoma City, OK
Novartis Investigative SiteCoral Gables, FL
Novartis Investigative SiteOklahoma City, OK
Novartis Investigative SiteMurray, UT
More Trial Locations
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Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

References

Urticaria: current opinions about etiology, diagnosis and therapy. [2007]In the last few decades an increasing understanding of the pathomechanisms involved in urticaria has highlighted the heterogeneity of different subtypes. According to the new European Academy of Allergology and Clinical Immunology/Global Allergy and Asthma European Network/European Dermatology Forum (EAACI/GA(2)LEN/ EDF) guidelines, urticaria subtypes can be grouped into spontaneous urticaria, which includes acute urticaria and chronic urticaria, the physical urticarias, and other urticaria disorders, including, for example, contact urticaria. Clarity of nomenclature is required not only to choose the correct measures in diagnosis and management, but also to compare data from different studies. Urticaria has a profound impact on quality of life and performance. Effective treatment is thus required in all cases where avoidance of eliciting factors is not feasible. For symptomatic relief, non-sedating H1-antihistamines are the first choice in most subtypes of urticaria; however, double-blind controlled studies have shown that the dosages required may exceed those recommended for other diseases, e.g. allergic rhinitis. The current guidelines therefore suggest increasing the dosage up to four-fold, whereas alternative treatments should be reserved as add-on therapy for unresponsive patients.
Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. [2022]Omalizumab (anti-IgE) therapy is effective and safe in chronic urticaria (CU) in placebo-controlled clinical trials but real life clinical data are scarce.
Omalizumab vs. placebo in the management of chronic idiopathic urticaria: a systematic review. [2023]To examine the evidence derived from randomized controlled clinical trials on the efficacy and safety of omalizumab compared to placebo in controlling symptoms of chronic idiopathic urticaria/chronic spontaneous urticaria (CIU/CSU).
Insights and advances in chronic urticaria: a Canadian perspective. [2022]In the past few years there have been significant advances which have changed the face of chronic urticaria. In this review, we aim to update physicians about clinically relevant advances in the classification, diagnosis and management of chronic urticaria that have occurred in recent years. These include clarification of the terminology used to describe and classify urticaria. We also detail the development and validation of instruments to assess urticaria and understand the impairment on quality-of-life and the morbidity caused by this disease. Additionally, the approach to management of chronic urticaria now focuses on evidence-based use of non-impairing, non-sedating H1-antihistamines given initially in standard doses and if this is not effective, in up to 4-fold doses. For urticaria refractory to H1-antihistamines, omalizumab treatment has emerged as an effective, safe option.
Socio-economic burden and resource utilisation in Italian patients with chronic urticaria: 2-year data from the AWARE study. [2022]Label="INTRODUCTION" NlmCategory="BACKGROUND">In Italy, the real-world evidence on the extent of adherence to guidelines and the benefits of recommended therapeutic medications and their impact on the quality of life (QoL) of H1-antihistamines (H1-AH) refractory chronic urticaria (CU) patients is limited.
Long-term follow-up of patients treated with dupilumab for chronic spontaneous urticaria: A case report. [2022]Several therapeutic strategies have been established to achieve maximal remission and improve quality of life in patients with chronic spontaneous urticaria. We previously reported dupilumab as a novel therapy for antihistamine-refractory chronic spontaneous urticaria patients who failed to respond to administration of omalizumab at increased doses for longer durations. This is the first case series to report data on the long-term duration of chronic spontaneous urticaria remission after discontinuation of dupilumab in patients who were able to obtain controlled chronic spontaneous urticaria. Six patients diagnosed with chronic spontaneous urticaria, who failed to respond to antihistamines and prolonged therapy with omalizumab at increased doses, were followed in this study for up to 34 months following initiation of dupilumab therapy. By demonstrating the maintenance of chronic spontaneous urticaria remission with dupilumab following discontinuation of therapy, in 67% of the patients, over an observation period up to 22 months, this case series highlights dupilumab's potential disease-modifying efficacy in patients affected by this disease.
Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. [2023]Chronic spontaneous urticaria (CSU) is inadequately controlled in many patients and greatly affects quality of life. Remibrutinib, a highly selective, oral, novel covalent Bruton tyrosine kinase inhibitor, might be effective in CSU.
Efficacy of Second-Line Treatments in Chronic Urticaria Refractory to Standard Dose Antihistamines. [2023]Label="PURPOSE" NlmCategory="OBJECTIVE">The prevalence of chronic urticaria (CU) is increasing worldwide, and it imposes a major burden on patients. Few studies have evaluated the efficacy of second-line treatments of CU, particularly for patients being considered for costly third-line treatments such as omalizumab. We compared the efficacy and safety of second-line treatments of CU refractory to standard doses of nonsedating H1-antihistamines (nsAHs).
Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. [2023]Remibrutinib (LOU064), an oral, highly selective Bruton tyrosine kinase inhibitor, offers fast disease control in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite treatment with second-generation H1 antihistamines. It is currently in phase 3 development for CSU.