A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines

PHASE3CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

January 15, 2022

Primary Completion Date

December 8, 2023

Study Completion Date

December 9, 2023

Conditions
Chronic Spontaneous Urticaria
Interventions
DRUG

LOU064

Each patient took one film-coated tablet in the morning and one film-coated tablet in the evening (except the morning dose at the PK sampling visits, which were to be taken on site during the visit).

Trial Locations (13)

454-0012

Novartis Investigative Site, Nagoya

279-0011

Novartis Investigative Site, Urayasu

595-0025

Novartis Investigative Site, Izumiōtsu

572-0838

Novartis Investigative Site, Neyagawa

593-8324

Novartis Investigative Site, Sakai

569-0824

Novartis Investigative Site, Takatsuki

693 8501

Novartis Investigative Site, Izumo

173-8610

Novartis Investigative Site, Itabashi-ku

108-0014

Novartis Investigative Site, Minato

143-0023

Novartis Investigative Site, Ōta-ku

811-1302

Novartis Investigative Site, Fukuoka

554 0014

Novartis Investigative Site, Osaka

558-0003

Novartis Investigative Site, Osaka

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY