Efficacy and safety of Xeligekimab (GR1501) in the treatment of axial Spondyloarthritis: Results from a Phase II clinical trial

Abstract Objective To evaluate the efficacy and safety of Xeligekimab (GR1501), a fully human monoclonal antibody against interleukin-17A, in Chinese patients with active axial spondyloarthritis (axSpA) who did not respond or were intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs). Methods This phase II, randomized, double-blind, placebo-controlled, multicenter study enrolled 160 patients with active axSpA. Participants were randomized equally to receive placebo or Xeligekimab at 100 mg, 200 mg, or 300 mg subcutaneously every two weeks for 16 weeks, followed by an 8-week follow-up. The primary endpoint was the Assessment of SpondyloArthritis International Society 20 (ASAS20) response at week 16. Secondary endpoints included ASAS40, ASDAS-CRP, BASDAI, BASFI, and patient-reported outcomes. Safety and immunogenicity were evaluated throughout the study. Results At week 16, ASAS20 response rates were 52.5% with placebo and 77.5%, 75.0%, and 72.5% with Xeligekimab 100 mg, 200 mg, and 300 mg, respectively. The 100 mg and 200 mg groups showed significant improvement versus placebo ( P < 0.05). Benefits in ASAS40, ASDAS-CRP, and BASDAI were maintained through week 24. Xeligekimab was generally well tolerated, and the overall incidence of adverse events was comparable to placebo. No treatment-emergent anti-drug antibodies were detected. Conclusion Xeligekimab at 100 mg and 200 mg achieved meaningful clinical improvement with good tolerability in patients with active axSpA, supporting further clinical evaluation of this therapy.