Remibrutinib for Chronic Urticaria

Recruiting in Palo Alto (17 mi)

+167 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

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)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). 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 in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period

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 Remibrutinib safe for humans?

Remibrutinib (also known as LOU064) has shown a favorable safety profile in patients with chronic spontaneous urticaria over a 52-week period. ^{1 2 3 4 5}

How is the drug Remibrutinib unique for treating chronic urticaria?

Remibrutinib is unique because it is an oral drug that specifically targets Bruton tyrosine kinase, offering fast disease control for chronic spontaneous urticaria, especially in patients who do not respond to standard antihistamines. ^{1 3 4 6 7}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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 am 18 years or older.

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

Trial Timeline

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

Treatment Details

Interventions

• Placebo (Other)
• Remibrutinib (Other)

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.

Participant Groups

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

Findings from Research

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 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]

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 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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Omalizumab is an effective and rapidly acting therapy in difficult-to-treat chronic urticaria: a retrospective clinical analysis. [2022]

2. France pubmed.ncbi.nlm.nih.gov

[Omalizumab for the treatment of chronic urticaria: Real-life findings]. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Omalizumab vs. placebo in the management of chronic idiopathic urticaria: a systematic review. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Remibrutinib demonstrates favorable safety profile and sustained efficacy in chronic spontaneous urticaria over 52 weeks. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Real-world treatment patterns and outcomes of omalizumab use in patients with chronic idiopathic urticaria. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Omalizumab Drug Survival in Chronic Urticaria: A Retrospective Multicentric French Study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Remibrutinib, a novel BTK inhibitor, demonstrates promising efficacy and safety in chronic spontaneous urticaria. [2023]