The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of remibrutinib (LOU064) in adult participants with moderate to severe hidradenitis suppurativa (HS) who have completed either of the preceding Phase 3 studies, CLOU064J12301 or CLOU064J12302.
Signed informed consent must be obtained before any assessment is performed.
Participant has completed the full study treatment period according to the protocol (68 weeks) in the core studies (CLOU064J12301 or CLOU064J12302).
Participant does not meet any treatment discontinuation criteria of the core study at Week 68.
Ongoing or planned use of prohibited HS or non-HS treatments.
Participants not expected to benefit from participation in the extension study or participants expected to be exposed to an undue safety risk if participating in the extension study, as assessed by the Investigator.
Current severe progressive or uncontrolled disease, which in the judgment of the Investigator renders the participant unsuitable for the study.
Parallel
Remibrutinib
DrugRemibrutinib Dose A and B (oral)
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Evaluate the safety of long-term treatment with remibrutinib in adult participants with moderate to severe Hidradenitis Suppurativa.
Proportion of participants with AN50/75/90 response
Achievement of AN50/75/90 is defined as at least a 50/75/90 (respectively)% decrease in Abscess and Inflammatory Nodule (AN) count compared to baseline.
Mean Percentage change from baseline in International Hidradenitis Suppurativa severity score system (IHS4)
The IHS4 is a disease severity score calculated as a weighted sum of inflammatory lesion counts: nodules (×1), abscesses (×2), and draining tunnels (×4). Scores are categorised as mild (≤3), moderate (4-10), and severe (≥11). Higher scores indicate greater disease severity (worse outcome).
Proportion of participants with Hidradenitis suppurativa clinical response (HiSCR)50/75/90 response
Achievement of HiSCR50/75/90 is defined as at least a 50/75/90 (respectively)% decrease in AN count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.
Proportion of participants with clinical response in HS-related skin pain (numerical rating scale [NRS] 30), at worst
Achievement of NRS30 among participants with baseline NRS ≥ 3 (in the core studies CLOU064J12301 and CLOU064J12302). NRS30 is defined as at least a 30% reduction and at least 2-unit reduction from baseline in Patient's Global Assessment of Skin Pain - at worst over the past 7 days.
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