A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis

The purpose of this study is to evaluate the safety and efficacy of upadacitinib in
participants with active ankylosing spondylitis (AS) who have had an inadequate response to
at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) or intolerance to or a
contraindication for NSAIDs, and who are naïve to biologic disease-modifying anti-rheumatic
drugs (bDMARD).

本研究旨在评估乌帕替尼（upadacitinib）对活动性强直性脊柱炎（ankylosing spondylitis, AS）受试者的安全性与有效性，此类受试者需满足以下条件：对至少2种非甾体抗炎药（non-steroidal anti-inflammatory drugs, NSAIDs）应答不足，或存在非甾体抗炎药不耐受、用药禁忌证，且未使用过生物类改善病情抗风湿药（biologic disease-modifying anti-rheumatic drugs, bDMARD）。