tibulizumab — Topline data
Q4 2026
• TibuSHIELD enrollment complete, exceeding initial enrollment target with 247 participants randomized in HS; topline data expected Q4 2026Source filing
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tibulizumab — Topline data
H1 2027
In December 2024, we initiated TibuSURE, a global, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating tibulizumab in participants with early diffuse cutaneous systemic sclerosis. Enrollment in TibuSURE is complete, exceeding the initial enrollment target with 91 participants. The study is designed to assess the safety, tolerability, and efficacy of tibulizumab in the relevant patient population. The study will evaluate tibulizumab over a 52-week period, which includes a 24-week efficacy period followed by a 28-week optional OLE. The primary endpoint is the modified Rodnan Skin Score. Key efficacy endpoints include lung disease, assessed by quantitative high-resolution computed tomography and forced vital capacity; physical function, measured by the Health Assessment Questionnaire-Disability Index; and the revised Combined Response Index in Systemic Sclerosis. Topline results are expected to be available in the first half of 2027.Source filing