Brief Title
A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis
Brief Summary
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.
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis. Subjects will be randomized to receive AK111 or placebo following subcutaneous injection. The study period for each subject will be 25 weeks, including a screening period of up to 35 days, followed by a treatment period of 12 weeks and a follow up period of 8 weeks.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16.
Secondary Outcome
Percentage of subjects who achieve SpondyloArthritis International Society 40% improvement (ASAS40) response at Week 16.
Condition
Ankylosing Spondylitis
Intervention
AK111
Study Arms / Comparison Groups
AK111 75mg
Description: AK111 75mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week12.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
125
Start Date
June 2, 2021
Completion Date
July 2022
Primary Completion Date
April 25, 2022
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT05467995
Organization ID
AK111-202
Responsible Party
Sponsor
Study Sponsor
Akeso
Study Sponsor
, ,
Verification Date
July 2022