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~89 spots leftby Aug 2025

Remibrutinib for Hives

Recruiting in Palo Alto (17 mi)

+127 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: Biologics, Anti-coagulants

Disqualifiers: Bleeding risk, Hepatic disease, others

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of the core phase of the trial is to assess the efficacy, safety and tolerability of remibrutinib (LOU064) 25 milligrams (mg) twice a day (b.i.d.) over placebo for 24 weeks and in comparison to omalizumab 300 mg every 4 weeks (q4w) for 52 weeks in participants with chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines (H1-AH). The purpose of the open-label extension phase is to assess efficacy, safety and tolerability up to two years for patients treated with remibrutinib and patients transitioned from omalizumab to remibrutinib at Week 52. In the extension phase, treatment will be with remibrutinib only (i.e., no background therapy). The extension phase will also fulfill the Novartis commitment to provide post-trial access to participants of the previous core phase.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it mentions that in the extension phase, treatment will be with remibrutinib only, without any background therapy. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Remibrutinib for treating hives?

Omalizumab (Xolair), a component of the treatment, has been shown to effectively reduce itching and the number and size of hives in patients with chronic spontaneous urticaria (a type of hives) when added to antihistamine therapy, improving patients' quality of life.¹ ² ³ ⁴ ⁵

Is Remibrutinib safe for humans?

Omalizumab, a treatment similar to Remibrutinib, has been generally well tolerated in clinical trials for conditions like chronic hives and asthma. Most side effects were mild or moderate, with headaches and upper respiratory infections being slightly more common. Anaphylaxis (a severe allergic reaction) was rare, occurring in about 0.1% to 0.2% of patients.¹ ² ³ ⁵ ⁶

How does the drug Remibrutinib differ from Omalizumab for treating hives?

Remibrutinib is a new treatment option for hives, while Omalizumab is an established drug that works by blocking IgE, a protein involved in allergic reactions. Remibrutinib's unique mechanism or benefits compared to Omalizumab are not detailed in the provided research, but it may offer an alternative for patients who do not respond to existing treatments.¹ ² ³ ⁵ ⁷

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adults over 18 with chronic spontaneous urticaria (CSU) not well-controlled by antihistamines can join. They must have had hives and itching for at least 6 weeks despite treatment, and be able to keep a daily diary of their symptoms without missing more than one entry in the week before starting.

Inclusion Criteria

I have had itch and hives for 6 weeks or more, even while using allergy medication.

Your UAS7 score, ISS7 score and HSS7 score were all at least 16, 6 and 6 respectively during the week leading up to randomization.

You are prepared to fulfill the demands of the UPDD over the course of the research and abide by its regulations.

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Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

1 visit (in-person)

Core Phase Treatment

Participants receive either remibrutinib, omalizumab, or placebo in a double-blind, double-dummy setup for 52 weeks

52 weeks

Regular visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks for non-extension participants, 4 weeks for extension participants

2 visits (in-person)

Open-label Extension

Optional phase where participants receive open-label remibrutinib for 52 weeks

52 weeks

Regular visits every 4 weeks

Treatment Details

Interventions

Omalizumab (Monoclonal Antibodies)
Placebo to omalizumab (Other)
Placebo to remibrutinib (Other)
Remibrutinib (Other)

Trial OverviewThe trial is testing Remibrutinib's effectiveness compared to a placebo and Omalizumab as an active control. Participants will take Remibrutinib or its placebo twice daily for 24 weeks, or Omalizumab every four weeks for 52 weeks.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: RemibrutinibExperimental Treatment1 Intervention

Participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks.

Group II: OmalizumabActive Control1 Intervention

participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks.

Group III: Placebo to remibrutinibPlacebo Group1 Intervention

Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w.

Group IV: Placebo to omalizumabPlacebo Group1 Intervention

Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d.