An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib
Chronic Spontaneous Urticaria
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring CSU, Brutons Tyrosine Kinase (BTK) inhibitor, Chronic Spontaneous Urticaria, Urticaria activity score, Hives severity score, Itch severity score, Extension, Randomized withdrawal, Retreatment upon relapse, Remibrutinib
Eligibility Criteria
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed.
- Male and female, adult participants ≥18 years of age.
- Participants who successfully completed the preceding core studies CLOU064A2301, CLOU064A2302, CLOU064A1301, CLOU064A2304 or CLOU064A2305 according to the respective protocols.
- Willing and able to adhere to the study protocol and visit schedule.
Exclusion Criteria:
- Significant bleeding risk or coagulation disorders.
- History of gastrointestinal bleeding.
- Requirement for anti-platelet medication.
- Requirement for anticoagulant medication.
- History or current hepatic disease.
- Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematological disorders, gastrointestinal disease or immunodeficiency that, in the investigator's opinion, would compromise the safety of the participant, interfere with the interpretation of the study results or otherwise preclude participation or protocol adherence of the participant.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Placebo Comparator
Experimental
Arm 1: LOU064 (blinded)
Arm 2: LOU064 Placebo (blinded)
Arm 3: LOU064 (Open Label)
LOU064 (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
LOU064 placebo (blinded) taken orally for 24 weeks, followed by cycles of either LOU064 (open-label) taken orally for a maximum of 5 cycles of 24 weeks each OR treatment-free observation cycles. Randomized in a 1:1 ratio (arm 1:arm 2)
LOU064 (open-label) taken orally for 24 weeks per treatment cycle (Arm 3)