Remibrutinib for Hives

Recruiting at 1 trial location

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: H1-AH

Must not be taking: Anticoagulants, Dual anti-platelet

Disqualifiers: Infectious diseases, Hepatitis, Cardiovascular, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

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 Chronic Urticaria (CU), including both Chronic Spontaneous Urticaria (CSU) and Chronic Inducible Urticaria (CINDU).

Eligibility Criteria

This trial is for individuals with Chronic Urticaria, including both spontaneous and inducible types. Participants must have had symptoms for at least 6 months, score high on urticaria severity scales, and be able to attend all study procedures. Those who can't commit or don't meet the symptom severity criteria cannot join.

Inclusion Criteria

I have signed the consent form to participate in this study.

My symptom scores are high enough for the study's requirements.

I have had chronic spontaneous urticaria for 6 months or more.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Treatment

Participants receive remibrutinib or placebo for 12 weeks

12 weeks

End of Study Visit

Participants have an end of study visit approximately 7 days after the last dose

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Remibrutinib

Trial Overview The study is testing Remibrutinib (LOU064), a potential new treatment for chronic urticaria against a placebo. It aims to assess its effectiveness in improving clinical outcomes and understand how it works in patients with this condition.

Participant Groups

Group I: LOU064-CSU Experimental Treatment 1 Intervention

Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled

Group II: LOU064-CINDU Experimental Treatment 1 Intervention

Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms.

Group III: Placebo-CINDU Placebo Group 1 Intervention

Diagnosis of Chronic Inducible Urticaria (CINDU), symptoms of symptomatic dermographism urticaria, cold urticaria, cholinergic urticaria, heat urticaria, solar urticaria, urticaria as diagnosed by pressure, evidence of urticaria after exposure to water, evidence of urticaria following contact to identified material causing urticaria symptoms.

Group IV: Placebo-CSU Placebo Group 1 Intervention

Diagnosis of Chronic Spontaneous Urticaria (CSU) not adequately controlled

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