Hidradenitis Suppurativa

A study to evaluate the efficacy and safety of subcutaneous sonelokimab compared with placebo in adult participants with moderate to severe hidradenitis suppurativa

• Population: Subjects 18 years and older
• Study Condition: Moderate to severe hidradenitis suppurativa (HS)
• Study Design: This is a Phase 3, multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of sonelokimab in adults with moderate to severe HS. Following a Screening Period of up to 28 days, each participant will enter a Placebo-controlled Period of 16 weeks (Part A) and subsequently a Crossover/Maintenance Period of 36 weeks (Part B). In Part A subjects will be randomly assigned in a 2:1 ratio to sonelokimab 120 mg or placebo. In Part B, participants who were initially randomized to placebo will cross over to sonelokimab and will receive this treatment for the remainder of the study. An End of Treatment (EOT) Visit will be performed at Week 52. After the EOT Visit, all participants who complete Week 52 will be offered the opportunity to enter an optional long-term open label extension (OLE) study under a separate protocol. For participants who do not progress to the OLE study, a Safety Follow-up Visit will be required 8 weeks after the last dose of study treatment.
• Compensation may be provided for participation

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 patients with moderate to severe hidradenitis suppurativa(HS)

• Population: Male and female participants aged 18 years or older at the time of enrollment.
• Study Condition: Diagnosis of HS is based on clinical history and physical examination for at least six months before the baseline visit. Participants must have moderate to severe HS, defined as having a total of at least five and count (abscesses and/or inflammatory nodules) and inflammatory lesions affecting at least two distinct anatomic areas
• Study Design: The Phase 3 study aims to assess the efficacy, safety, and tolerability of remibrutinib in adult patients with moderate to severe hidradenitis suppurativa. This global, double-blind, placebo-controlled study will evaluate remibrutinib at doses of 10 mg twice a day and 25 mg twice a day vs matching placebo twice a day in participants with moderate to severe HS.
• Compensation is provided for participation
• Study is currently enrolling

An open-label, single-arm study to evaluate the pharmacokinetics and safety of subcutaneous sonelokimab in adolescents aged ≥12 to ≤17 years at the time of study inclusion with active moderate to severe hidradenitis suppurativa (HS).

• Population: Adolescent participants (aged ≥12 to ≤17 years) with moderate to severe HS
• Stud Condition: moderate to severe HS (determined by refined Hurley stages IB and C, IIB and C, and III; and presenting a total abscesses or inflammatory nodules (AN) count of ≥5 or ANs present in >2 distinct anatomical areas
• Study Design: open-label, single-arm design has been selected to characterize PK and assess the safety and tolerability of sonelokimab in adolescent patients with HS.
• Compensation is provided for participants
• Study is currently enrolling