A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa. (RECHARGE-1)
A Randomized, Double-blind, Double-dummy, Placebo-controlled, Multicenter, Phase 3 Study Assessing the Efficacy, Safety, and Tolerability of 2 Doses of Remibrutinib Over a 68-week Treatment Period in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa. (RECHARGE-1)
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.
Key Inclusion Criteria:
Male and female participants ≥ 12 years of age at the time of signing of the informed consent.
Diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the Baseline visit.
Participants with moderate to severe HS defined as:
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Caba, Buenos Aires C1119ACN, Argentina
CABA, Buenos Aires C1425BEA, Argentina
CABA, C1428DZF, Argentina
Xian, Shanxi 710004, China
Bogota, Cundinamarca 110221, Colombia
Heraklion Crete., 715 00, Greece
Raslouw Centurion, Gauteng 0157, South Africa