SUNSHINE
About the trial
This is a multicenter, randomized, double-blind, placebo-controlled, parallel group study with two secukinumab dose regimens in approximately 541 patients with moderate to severe Hidradenitis Suppurativa (HS). The purpose of this study is to demonstrate superiority of secukinumab at Week 16, based on Hidradenitis Suppurativa Clinical Response (HiSCR) rates versus placebo, along with the maintenance of efficacy of secukinumab at Week 52 in subjects with moderate to severe HS. Moreover, this study will also assess the safety and tolerability of secukinumab.
545 participants in 111 study locations are enrolled in the study.
How DCR - CIU supports the trial
DCR - CIU is involved in multiple aspects of the trial conduct: the planning, coordination and conduct of the study visits; collection, processing, storage and shipping of biological samples, IMP dispensing and accountability, maintenance of the Investigator Site File, and data entry.
Principal Investigator
Prof. Dr. med. et. Dr. phil. nat. Robert Hunger, Universitätsklinik für Dermatologie
Sponsor
Novartis Pharmaceuticals