NCT06865651

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

A 12-week Randomized, Participant and Investigator-blinded, Placebo-controlled, Exploratory Study in Adult Participants With Chronic Urticaria to Assess the Efficacy and Safety and Explore the Mechanism of Action of Remibrutinib (LOU064)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

This is a randomized, parallel-group, participant and investigator-blinded, placebo controlled, multi-center study in approximately 44 adult participants that are diagnosed with a form of CU and have symptoms despite treatment with H1-antihistamines. The following nine subtypes of CU are included: * CINDU cohorts: Symptomatic dermographism, Cold urticaria, Cholinergic urticaria, Heat urticaria, Solar urticaria, Delayed pressure urticaria, Aquagenic urticaria, Contact urticaria * CSU The study will attempt to enroll approximately 4-5 participants for each subtype. Participants will undergo a screening period for completion of the assessment to check eligibility criteria which will take approximately up to 4 weeks. After enrollment, the treatment will be initiated. Participants will either receive remibrutinib or placebo for 12 weeks. Participants have an end of study visit approximately 7 days after the last dose. All participants will have a safety follow-up phone call approximately 30 days after last treatment administration.

Conditions

• Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)

Interventions

Type	Name	Description
DRUG	Remibrutinib	tablets
DRUG	Placebo	tablets

Timeline

• Start date: 2025-05-22
• Primary completion: 2027-08-23
• Completion: 2027-09-28
• First posted: 2025-03-10
• Last updated: 2026-03-30

Locations

17 sites across 5 countries: United States, France, Germany, Poland, Spain

Regulatory

• FDA-regulated drug study