Remibrutinib for Chronic Urticaria

Not currently recruiting at 180 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: BTK inhibitors

Disqualifiers: CSU, Familial CINDU, Urticarial vasculitis, 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 examines how well the drug remibrutinib works for people with chronic urticaria, a persistent skin condition causing itchy hives that doesn't improve with standard allergy medications. It compares remibrutinib to a placebo, a harmless pill with no active drug, to determine if it helps reduce symptoms. The trial is open to adults who have experienced certain types of chronic urticaria, such as cold urticaria or cholinergic urticaria, for at least four months without relief from typical antihistamines. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must have chronic urticaria not adequately controlled by H1-antihistamines, which suggests you may continue taking them if they are not effective enough.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that remibrutinib is generally safe. In earlier studies, patients experienced quick and lasting symptom relief and found the treatment safe. One study found that remibrutinib was well-tolerated for up to 52 weeks in patients with conditions like chronic spontaneous urticaria (CSU). Most side effects were mild to moderate, and no major safety issues were reported.

Prospective participants should know that remibrutinib has already shown promise in helping people with similar symptoms, and serious side effects are uncommon. ^{1 2 3 4 5}

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

Most treatments for chronic urticaria, like antihistamines, work by blocking histamine receptors to reduce symptoms. But Remibrutinib works differently, targeting Bruton’s tyrosine kinase (BTK), a key enzyme involved in the allergic response. This unique mechanism may offer relief for patients who don't respond well to standard treatments. Researchers are excited because Remibrutinib could potentially provide faster, more effective symptom control for chronic urticaria, including challenging types like cold urticaria, cholinergic urticaria, and symptomatic dermographism.

What evidence suggests that remibrutinib might be an effective treatment for chronic urticaria?

Research shows that remibrutinib, one of the treatments studied in this trial, may help treat chronic urticaria, also known as hives. In previous studies, participants taking remibrutinib significantly reduced their UAS7 scores, which measure hives' severity, by Week 12 compared to those taking a placebo. On average, the scores dropped by more than 7 points, marking a significant improvement. Remibrutinib is also considered one of the best options for patients whose hives don't improve with antihistamines. It is generally safe and well-tolerated. These findings suggest that remibrutinib could effectively treat chronic urticaria. Participants in this trial will receive either remibrutinib or a placebo, depending on their assigned treatment group. ^{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 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.

Inclusion Criteria

My doctor says my hives are moderate to severe, and I feel a lot of itchiness.

I have severe skin writing with itching scored high on a specific test.

I have been diagnosed with a chronic skin condition for over 4 months and treatments haven't worked well.

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

24 weeks of double-blind treatment with remibrutinib or placebo

24 weeks

Open-label treatment

28 weeks of open-label treatment with remibrutinib

28 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label Extension

Participants may opt into continuation of treatment long-term, switching between observation and treatment based on symptoms

approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Remibrutinib

Trial Overview 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.

How Is the Trial Designed?

Group I: Remibrutinib, symptomatic dermographism group Experimental Treatment 1 Intervention

Remibrutinib oral twice daily in participants with symptomatic dermographism

Group II: Remibrutinib, cold urticaria group Experimental Treatment 1 Intervention

Remibrutinib oral twice daily, cold urticaria

Group III: Remibrutinib, cholinergic urticaria group Experimental Treatment 1 Intervention

Remibrutinib oral twice daily, cholinergic urticaria

Group IV: Placebo, cholinergic urticaria Placebo Group 1 Intervention

Placebo oral twice daily, cholinergic urticaria

Group V: Placebo, cold urticaria group Placebo Group 1 Intervention

Placebo oral twice daily, cold urticaria

Group VI: Placebo, symptomatic dermographism group Placebo Group 1 Intervention

Placebo oral twice daily, symptomatic dermographism

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

Published Research Related to This Trial

In a real-life clinical analysis of 51 chronic urticaria patients, omalizumab demonstrated high efficacy, achieving complete remission in 83% of patients with chronic spontaneous urticaria (CSU) and 70% with chronic inducible urticaria (CindU).

Omalizumab was found to be safe, with rapid symptom relief occurring within the first week for 57% of CSU patients, and the treatment's effectiveness was not influenced by baseline IgE levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. Metz, M., Ohanyan, T., Church, MK., et al.[2022]

In a phase 2b trial involving 311 patients with chronic spontaneous urticaria (CSU), remibrutinib demonstrated significant efficacy in reducing symptoms, with all doses showing improvement compared to placebo by week 4.

Remibrutinib was well-tolerated, with most adverse events being mild or moderate, indicating a favorable safety profile across various doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. Maurer, M., Berger, W., Giménez-Arnau, A., et al.[2023]

Omalizumab 300 mg significantly reduced symptoms of chronic idiopathic urticaria (CIU) compared to placebo, with a notable decrease in urticarial activity scores and itch severity scores across multiple studies involving 1117 patients.

The treatment also increased the percentage of angioedema-free days, indicating its efficacy in managing symptoms that are resistant to conventional antihistamine treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab vs. placebo in the management of chronic idiopathic urticaria: a systematic review. Carrillo, DC., Borges, MS., García, E., et al.[2023]

In a phase 2b extension study involving 230 patients with chronic spontaneous urticaria (CSU), remibrutinib showed a favorable safety profile, with most adverse events being mild to moderate and not directly related to the treatment.

Remibrutinib provided significant and sustained efficacy, with 55.8% of patients achieving complete response (UAS7 = 0) and 68.0% achieving well-controlled disease (UAS7 ≤6) after 52 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. Jain, V., Giménez-Arnau, A., Hayama, K., et al.[2023]

In a study of 23 patients with chronic urticaria who were unresponsive to standard treatments, omalizumab resulted in complete or significant remission in 83% of cases, with nearly half experiencing remission within 72 hours of the first injection.

While 52% of patients reported non-serious side effects, only one patient had to stop treatment due to adverse events, indicating that omalizumab is generally safe and effective for managing chronic urticaria in real-life settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Omalizumab for the treatment of chronic urticaria: Real-life findings]. Hamelin, A., Amsler, E., Mathelier-Fusade, P., et al.[2019]

In a study of 88 patients with chronic idiopathic urticaria (CIU) treated with omalizumab, 83.7% reported improvement in their condition after starting the therapy, indicating its efficacy in real-world settings.

The use of oral corticosteroids decreased from 52.3% to 39.8% after initiating omalizumab treatment, suggesting that omalizumab may help reduce the need for additional medications in managing CIU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world treatment patterns and outcomes of omalizumab use in patients with chronic idiopathic urticaria. Wang, L., Ke, X., Kavati, A., et al.[2022]

In a study of 878 French patients with chronic urticaria, omalizumab (OMA) showed a longer drug survival rate compared to previous studies, with 50% of patients still on treatment 2.4 years after starting.

The main reason for discontinuing OMA was achieving well-controlled disease in 50% of patients, but many were able to restart treatment, indicating its effectiveness in managing chronic urticaria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. Litovsky, J., Hacard, F., Tétart, F., et al.[2023]

Citations

1. 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 ...

2. novartis.com novartis.com/clinicaltrials/study/nct05976243

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 ...

3. 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 - ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0091674925006463

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 ...

5. eadv.org eadv.org/wp-content/uploads/scientific-abstracts/EADV-congress-2023/Urticaria.pdf

Abstract N°: 65 Remibrutinib (LOU064) showed ... Conclusion: This study confirms that low-dose omalizumab shows favorable treatment outcomes in patients with antihistamine-refractory chronic ...

6. jacionline.org jacionline.org/article/S0091-6749(23)01346-5/fulltext

Remibrutinib demonstrates favorable safety profile and ... Remibrutinib demonstrated a consistent favorable safety profile with fast and sustained efficacy for up to 52 weeks in patients with CSU. Key ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05976243

NCT05976243 | A Study to Investigate Efficacy, Safety, and ... The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo ...