The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
The total duration of the study is 76 weeks and consists of: Screening (up to 4 weeks), Treatment Period 1 (16 weeks, double-blind treatment with remibrutinib (Dose A or Dose B) or placebo, Treatment Period 2 (52 weeks, treatment with remibrutinib (Dose A or Dose B) and Safety Follow-Up (treatment-free follow-up for 4 weeks). Participants who prematurely discontinue study treatment (either during Treatment Period 1 or Treatment Period 2) are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
555
Remibrutinib Dose A (oral)
Remibrutinib Dose B (oral)
Placebo matching to remibrutinib Dose A (oral)
Proportion of participants with Hidradenitis Suppurativa clinical response 50 (HiSCR50) at Week 16
HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.
Time frame: Week 16
Proportion of participants with Abscesses and inflammatory nodules 50 (AN50) response at Week 16
AN50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count compared to baseline
Time frame: Week 16
Percentage change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16
The IHS4 is a disease severity scoring system developed by the European Hidradenitis Suppurativa Foundation. It is a weighted sum of different types of inflammatory lesion counts, calculated as 1 x number of nodules + 2 x number of abscesses + 4 x number of draining tunnels (=fistulae=sinuses).
Time frame: From baseline up to Week 16
Proportion of participants with HiSCR75 response at Week 16
HiSCR75 is defined as at least a 75% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.
Time frame: Week 16
Proportion of participants experiencing Hidradenitis Suppurativa (HS) flares at Week 16
Flare is defined as at least a 25% increase in AN count with a minimum increase of 2 AN relative to baseline.
Time frame: Up to Week 16
Proportion of participants with HiSCR50 response at Week 8
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Placebo matching to remibrutinib Dose B (oral)
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HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.
Time frame: Week 8
Proportion of participants with HiSCR90 response at Week 16
HiSCR90 is defined as at least a 90% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and in the number of draining tunnels/fistulae compared to baseline.
Time frame: Week 16
Proportion of participants with clinical response in HS related skin pain (NRS 30), at worst at Week 16
Achievement of NRS30 at Week 16, among participants with baseline NRS ≥ 3 (pooled data from 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.
Time frame: Week 16
Incidence of treatment emergent adverse events and serious adverse events during the study
The distribution of adverse events will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.
Time frame: From randomization to end of study, assessed up to 72 weeks.