A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY, PHARMACOKINETICS AND SAFETY OF REMIBRUTINIB (LOU064) FOR 24 WEEKS IN ADOLESCENTS FROM 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC SPONTANEOUS URTICARIA INADEQUATELY CONTROLLED BY H1-ANTIHISTAMINES FOLLOWED BY AN OPTIONAL OPEN-LABEL EXTENSION FOR UP TO ANOTHER 3 YEARS AND AN OPTIONAL SAFETY LONG-TERM TREATMENT-FREE FOLLOW-UP PERIOD FOR UP TO AN ADDITIONAL 3 YEARS

Registry ID

CLOU064F12301

Source registry

HEALTH_CANADA

Status

Ongoing

Study type

INTERVENTIONAL

Sponsor

NOVARTIS PHARMACEUTICALS CANADA INC

Start date

2025-01-31

Last update

2023-03-13

Conditions

• CHRONIC SPONTANEOUS URTICARIA (CSU)

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