A multicenter, double-blind, placebo-controlled, randomized withdrawal and open-label extension study followed by long-term open-label treatment cycles to assess the efficacy, safety and tolerability of remibrutinib (LOU064) in adult chronic spontaneous urticaria patients who completed the preceding remibrutinib Phase 3 studies)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-510818-33-00

Acronym

CLOU064A2303B

Enrollment

200

Registered

2024-08-21

Start date

2023-01-24

Completion date

Unknown

Last updated

2026-01-16

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

Time to first composite event (i.e., relapse (UAS7≥16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the randomized withdrawal period.

Detailed description

Safety endpoints will include but not be limited to: occurrence of treatment-emergent (serious and non-serious) adverse events during the extension study

Interventions

DRUG-

DRUGLOU064

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first composite event (i.e., relapse (UAS7≥16), study treatment discontinuation due to lack of efficacy or intake of strongly confounding prohibited medication) during the randomized withdrawal period.	—

Secondary

Measure	Time frame
Safety endpoints will include but not be limited to: occurrence of treatment-emergent (serious and non-serious) adverse events during the extension study	—

Countries

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

Outcome results

None listed

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