TibuSHIELD: A phase 2 randomized, double-blind, placebo-controlled study of Tibulizumab in adults with moderate-to-severe Hidradenitis Suppurativa

Background: Hidradenitis suppurativa (HS) is a chronic, relapsing inflammatory skin disease that is characterized by recurrent painful nodules, abscesses, and draining tunnels. Over time, these lesions can progress to scarring and place a substantial burden on patients, with significant impacts on quality of life, physical health, and psychological wellbeing. Approved HS therapies primarily target specific inflammatory pathways, despite the complex and multifactorial nature of the disease. Tibulizumab is an investigational dual antagonist of interleukin17 (IL-17) and B-cell activating factor (BAFF) currently being studied for its potential to simultaneously inhibit neutrophilic and B-cell drivers, two key pathogenic factors of HS. Objective: This randomized, double-blinded, placebo-controlled study will evaluate the efficacy, safety, and tolerability of tibulizumab in adults with HS. Methods: 247 participants aged 18–70 were randomized 1:1:1 to receive two different doses of tibulizumab or placebo during a double-blind 16-week treatment period. Patients who complete treatment in the double-blind period will be eligible for the 16-week open label extension. The primary endpoint is change from baseline (CFB) in abscess and inflammatory nodule (AN) count at week 16. Key secondary endpoints include HS Clinical Response ≥50% and ≥75% (HiSCR50 and HiSCR75), absolute CFB in Dermatology Life Quality Index (DLQI), absolute CFB in HS Patient’s Global Assessment (HS-PtGA), and absolute CFB in skin pain numerical rating scale (NRS) at week 16. Safety and tolerability will be investigated through treatment-emergent adverse events, electrocardiogram, vital signs, and clinical laboratory assessments. Key inclusion criteria includes ≥6-months history of HS with lesions in ≥2 distinct anatomical areas, at least one of which is Hurley Stage II or III, total AN count ≥5, ≤20 draining tunnels, inadequate response to an appropriate course of oral antibiotics or intolerance or contraindication to oral antibiotics, and agreement to use highly effective contraception methods. Results: This study is ongoing. Outcomes will be reported when data are available. Conclusion: TibuSHIELD (NCT06993610) is the first randomized clinical trial investigating the effect of tibulizumab, a dual IL-17/BAFF antagonist antibody, in adults with HS. Support statement: This abstract was supported and funded by Zura Bio. Please note: This abstract is an encore of work previously presented at SHSA 2025.