Novartis Pharmaceuticals
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.
This is a Phase 1, interventional, multicenter, randomized, double-blind, parallel group, placebo-controlled, exploratory study to evaluate the MoA of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa. The total duration of the study is 24 weeks and consists of Screening (up to 4 weeks), Treatment (16 weeks, double-blind treatment with remibrutinib or placebo), and Follow-up (treatment-free follow-up for 4 weeks) periods.
Key Inclusion Criteria: * 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. * Participants with moderate to severe HS at Day 1 defined as: * 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). * At least 1 chronic lesion, which is defined by the presence of a drain…
Remibrutinib
matching placebo
Arctuva estimate
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