A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

AK111-202

This is a phase 2, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of AK111 in subjects with active ankylosing spondylitis.

2021-06-02

2022-04-25

2022-05-19

Completed

Early phase I

125

Inclusion Criteria: * Male or female subjects aged 18-75 years old. * Ankylosing spondylitis has been diagnosed for at least 6 months before screening, with radiological evidence that meets the Modified New York Criteria for Ankylosing Spondylitis. * Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Spinal pain score≥ 4 (based on BASDAI question 2). * Subjects received at least 1 kind of non-steroidal anti-inflammatory drugs (NSAIDs), prior to randomization with an inadequate response or failure to respond. * Subjects who are regularly taking NSAIDs, weak opioids or oral glucocorticoids as part of their AS therapy are required to be on a stable dose for at least 14 days before randomization. * Subjects taking methotrexate (MTX) (≤25mg/week) or Sulfasalazine (≤3g/day) are allowed to continue their medication if started at least 12 weeks prior to Baseline, with a stable dose for at least 4 weeks before randomization. Exclusion Criteria: * Subjects with total ankylosis of the spine. * Subjects with progressive or uncontrolled diseases of respiratory, circulatory, digestive, urogenital, endocrine, nervous or mental systems, or with other chronic diseases that are not suitable to participate to the study. * Subjects with other inflammatory diseases or autoimmune diseases except Ankylosing spondylitis (AS). * Subjects with any severe systemic or local infection within 2 months before screening. * Subjects who are using strong opioid analgesics. * Combined use of Disease Modifying Anti-Rheumatic Drugs (DMARDs) other than methotrexate and sulfasalazine, including but not limited to thalidomide, iguratimod, etc. within 4 weeks before randomization. * Received any live vaccine within 2 months before screening or planned to receive any live vaccine during the study period. * Previous exposure to secukinumab, ixekizumab or any other biologic drug directly targeting IL-17 or IL-17 receptor. * Received Natalizumab or other drugs that regulate B cells or T cells within 6 months before screening. * Received more than 2 kinds of Tumor necrosis factor alpha(TNF-α) inhibitors before screening.

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2024-03-06