A Study to Evaluate the Efficacy and Safety of AK111 in Subjects With Active Ankylosing Spondylitis

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 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

, , 

Location Countries

China

Location Countries

China

NCT ID

NCT05467995

Organization ID

AK111-202

Responsible Party

Sponsor

Study Sponsor

Akeso

Study Sponsor

, , 

Verification Date

July 2022