This study aims to better understand how Bruton's tyrosine kinase (BTK) inhibition with remibrutinib works in hidradenitis suppurativa (HS), a complex inflammatory disease with different types of lesions.
Male and female participants ≥ 18 years to 65 years of age at the time of signing of the informed consent forms (ICF).
Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to Day 1.
A total of at least 5 abscesses and inflammatory nodules (AN), i.e. abscesses and/or inflammatory nodules
Inflammatory lesions should affect at least 2 distinct anatomic areas (e.g., left and right axillae).
Presence of more than 20 fistulae/tunnels (both draining and non-draining) in total at baseline.
Use of other investigational drugs within 5 half-lives, or within 30 days (for small molecules) prior to randomization, or until the pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
Previous exposure to remibrutinib or other BTK inhibitors.
Previous exposure to investigational Janus Kinase (JAK) inhibitors.
Parallel
LOU064
DrugRemibrutinib
Placebo
Drugmatching placebo
Fold change from baseline in auto-antibodies
To evaluate the effect of remibrutinib compared with placebo.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including changes in vital signs and laboratory values qualifying and reported as AEs.
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