A Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo and With Omalizumab as Active Control in CSU Adult Patients.
Chronic Spontaneous Urticaria
About this trial
This is an interventional treatment trial for Chronic Spontaneous Urticaria focused on measuring CSU, urticaria, LOU064, omalizumab, remibrutinib
Eligibility Criteria
Inclusion Criteria: Male and female adult participants ≥18 years of age at the time of signing the informed consent. CSU duration for ≥ 6 months prior to screening. Diagnosis of CSU inadequately controlled by second generation H1-AH at the time of randomization, defined as: The presence of itch and hives for ≥6 consecutive weeks prior to screening, despite the use of second-generation H1-AH during this time period. UAS7 score (range 0-42) ≥16, ISS7 score (range 0-21) ≥ 6 and HSS7 score (range 0- 21) ≥ 6 during the 7 days prior to randomization (Day 1). Documentation of hives within three months before randomization. Willing and able to complete an Urticaria Patient Daily Diary (UPDD) for the duration of the study and adhere to the study protocol. Participants must not have had more than one missing UPDD entry (either morning or evening) in the 7 days prior to randomization (Day 1). Exclusion Criteria: Prior exposure to ligelizumab, omalizumab and other biologics with any effect in CSU, including anti-IgE therapies. Significant bleeding risk or coagulation disorders. History of gastrointestinal bleeding. Requirement for anti-platelet or anti-coagulant 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. Evidence of helminthic parasitic infection as evidenced by stools being positive for a pathogenic organism according to local guidelines. Documented history of anaphylaxis.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Placebo Comparator
Active Comparator
Remibrutinib
Placebo to remibrutinib
Placebo to omalizumab
Omalizumab
Participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 52 weeks.
Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w.
Participants will receive placebo for remibrutinib 25 mg b.i.d. and placebo for omalizumab q4w for 24 weeks. From Week 24 to Week 52 participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d.
participants will receive omalizumab 300 mg q4w and placebo for remibrutinib b.i.d. for 52 weeks.