A global, multicenter, randomized, double-blind, double-dummy, parallel-group, Phase 3b study to assess the efficacy, safety, and tolerability of remibrutinib 25 mg b.i.d. in comparison to placebo with omalizumab 300 mg every 4 weeks as active control over 52 weeks in adult patients with chronic spontaneous urticaria inadequately controlled by second-generation H1-antihistamines and an open-label 52-week optional extension to assess long-term efficacy, safety and tolerability of remibrutinib 25 mg b.i.d.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502161-19-00

Acronym

CLOU064A2304

Enrollment

194

Registered

2024-02-12

Start date

2024-03-12

Completion date

Unknown

Last updated

2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Spontaneous Urticaria

Brief summary

Absolute change from baseline in UAS7, ISS7 and HSS7 at Week 12

Detailed description

Achievement of UAS7=0 (yes/no) at Week 12, Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 12, Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 12, Absolute change from baseline in UAS7 at Week 12, Occurrence of treatment-emergent adverse events and serious adverse events (SAEs) during the study

Interventions

DRUGPlacebo to Remibrutinib (LOU064) 25 mg film-coated tablet

DRUG-

DRUGLOU064

DRUGPlacebo to AIN457 150 mg/ 1 mL Solution for injection in pre-filled syringe. This placebo is an additional/ alternative placebo to placebo to Xolair® (Omalizumab) to ensure continuous supply in the clinical trial. For more details please refer to Note to Assessor located in the “Placebo to AIN457” product shell.

DRUGPlacebo to Xolair® (Omalizumab) 150 mg/ml solution for injection in pre-filled syringe

DRUGOMALIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Absolute change from baseline in UAS7, ISS7 and HSS7 at Week 12	—

Secondary

Measure	Time frame
Achievement of UAS7=0 (yes/no) at Week 12, Improvement of severity of itch, assessed as absolute change from baseline in ISS7 score at Week 12, Improvement of severity of hives, assessed as absolute change from baseline in HSS7 score at Week 12, Absolute change from baseline in UAS7 at Week 12, Occurrence of treatment-emergent adverse events and serious adverse events (SAEs) during the study	—

Countries

Bulgaria, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026