Study of Efficacy and Safety of GR1501 in Patients with Radiographic Axial Spondyloarthritis

Summary

The purpose of this trial is to demonstrate the clinical efficacy of GR1501 at week 16; and to demonstrate safety and tolerability of GR1501 compared to placebo in patients with Radiographic Axial Spondyloarthritis at week 16 and long term safety up to Week 48。 The main question it aims to answer is whether GR1501 injection was superior to placebo in the proportion of subjects with ASAS20 response at week 16 in patients with Radiographic Axial Spondyloarthritis.

Timeline

Start

2022-06-13

Primary completion

2023-12-18

Completion

2024-05-21

Outcome

Met primary endpoint

paper A significantly higher proportion of patients receiving xeligekimab 200 mg (n = 114 (74.0%); p < 0.001 PMID 41247398 ↗

paper achieved an ASAS20 response compared to the placebo group (n = 56 (35.9%)) at week 16. PMID 41247398 ↗

release “赛立奇单抗治疗AS的Ⅲ期数据表现亮眼疗效数据显示，16周时，研究达到主要终点，赛立奇单抗200mg组的ASAS 20应答率高达74.0％” genrixbio.com ↗

Publications

• Zhang S, Xu D, Liu S, Li S, Wang X, Yuan F, Gou W, Xu B, Sun L, Gu J, Zhou D, Li X, Kong N, Zhao Y, Hao J, Li T, Fan X, Shu Q, Wei H, Jiang T, Yang J, Qian L, Sun H, Cai X, Jiang Z, Yuan G, Qin L, Yang M, Xu J, Fan W, Sun L, Zhang H, Zhang C, Zhang N, Da Z, Hu J, Jin J, Liu J, Dai L, Dong L, Wang W, Zeng X. Xeligekimab, an Interleukin-17A Antagonist for Active Radiographic Axial Spondyloarthritis in Chinese Patients: 16- and 48-Week Results from a Phase III, Randomized, Double-Blind, Placebo-Controlled Study. BioDrugs. 2026 Jan;40(1):151-162. doi: 10.1007/s40259-025-00750-0. Epub 2025 Nov 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Xeligekimab	Monoclonal antibody	100 mg	—
Subject	Xeligekimab	Monoclonal antibody	200 mg	—

Indications