Study Description
The purpose of this extension study is to collect long-term efficacy, safety and
tolerability data on remibrutinib in a selected group of participants with Chronic
Spontaneous Urticaria (CSU) who previously completed the treatment phase of remibrutinib
preceding Phase 3 studies.
This study will also fulfill the Novartis commitment to provide post-trial access to
participants who have completed the preceding Phase 3 studies, where applicable. This is a global, multicenter, randomized, double-blind, placebo-controlled, randomized
withdrawal Phase 3b extension study, followed by long-term open label treatment cycles to
assess the efficacy, safety and tolerability of remibrutinib in adult participants with
CSU inadequately controlled by H1-AH. The study comprises 2 Epochs. Epoch 1 is the
initial study period for participants who completed preceding remibrutinib Phase 3
studies. Epoch 1 comprises of a 24-week randomized withdrawal period with remibrutinib or
placebo for patients with UAS7<16 OR a 24 week Open-label treatment period with
remibrutinib for patients with UAS7≥16.
Participants will be randomized in a 1:1 ratio to enter the double-blind
placebo-controlled 24-week withdrawal phase. In case of relapse (UAS7≥16) in the blinded
group, participants enter the (Re-)treatment period Epoch 1 and receive 24 weeks of
Open-label treatment with remibrutinib. At the end of the (Re-)treatment period Epoch 1,
participants will move to Epoch 2.
Epoch 2 is the second subsequent study period and consists of 24-week cycles that could
either encompass treatment-free Observation and/or Open-label (Re-)treatment periods with
remibrutinib, with or without background H1-AH.
In case of relapse (UAS7≥16) during an Observation period, participants enter the next
(Re-)treatment period and receive 24 weeks of treatment with remibrutinib. Participants
completing an Observation period 2/3/4/5 with a UAS7≤6 will complete the study.
Participants with a UAS7 >6 -<16 can enter the next (Re-)treatment period if continuous
treatment is considered necessary and beneficial for the individual participant. For
participants with a UAS7<16 that enter the next (Re-)treatment period, remibrutinib
monotherapy treatment (without background H1-AH) is required.
Interventions
LOU064 (blinded)
LOU064 (open label)
Placebo
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.
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