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Clinical Trials/NCT06378697
NCT06378697
Completed
Phase 3

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

Akeso54 sites in 1 country510 target enrollmentNovember 22, 2023

Overview

Phase
Phase 3
Intervention
AK111
Conditions
Ankylosing Spondylitis
Sponsor
Akeso
Enrollment
510
Locations
54
Primary Endpoint
the response rate of ASAS20
Status
Completed
Last Updated
last month

Overview

Brief Summary

This is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study to evaluate the efficacy and safety of AK111 in the treatment of subjects with active ankylosing spondylitis.

Detailed Description

The study consists of 3 parts. Part 1 is screening period, Part 2 is Placebo control period and part 3 is Long term treatment follow-up period. The research period is 61 weeks in total.

Registry
clinicaltrials.gov
Start Date
November 22, 2023
End Date
November 7, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Akeso
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male or female subjects aged ≥18 years old.
  • Subjects with confirmed ankylosing spondylitis before screening.
  • During screening and before randomization, BASDAI score ≥ 4, total back pain score≥
  • Subjects received at least 2 kind of non-steroidal anti-inflammatory drugs (NSAIDs), prior to randomization with an inadequate response or failure to respond, or with contraindications or intolerance to the use of NSAIDs.
  • Subjects who are regularly taking NSAIDs, weak opioids or oral glucocorticoids(The daily dose should be ≤10mg prednisone or equivalent dose of glucocorticoid) as part of their AS therapy are required to be on a stable dose for at least 14 days before randomization. If the drug has been discontinued, at least 2 weeks washout period is required 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. If the drug has been discontinued, at least 4 weeks washout period is required before randomization.
  • Subjects who are able to understand and voluntarily sign the ICF and complete the study procedure.

Exclusion Criteria

  • Subjects with symptom of pain that affected the evaluation of efficacy.
  • Subjects with other inflammatory diseases or autoimmune diseases except Ankylosing spondylitis (AS).
  • Subjects who are using strong opioid analgesics.
  • Received glucocorticoid intramuscular or intravenous injection within 2 weeks prior to randomization; Received intraarticular or paraspinal glucocorticoid therapy within 4 weeks before randomization.
  • Received other antirheumatic drugs (except methotrexate, sulfasalazine), proprietary Chinese medicine or traditional Chinese medicine decoction, JAK inhibitor treatment for AS within 4 weeks before randomization.
  • Received Natalizumab or other B cell or T cell modulator in the 12 months prior to randomization.
  • Previous exposure to secukinumab, ixekizumab or any other biologic drug directly targeting IL-17 or IL-17 receptor.
  • Received multiple tumor necrosis factor α (TNF-α) inhibitors; The eluting period of biologics received before randomization is shorter than the protocol.
  • Participated in a clinical study of any other drug or medical device within 1 month (≤30 days) prior to randomization, or last received the investigational drug within 5 half-lives.
  • The presence of any other systemic disease or laboratory abnormalities that the investigator has judged unsuitable for clinical trials.

Arms & Interventions

AK111

AK111 150 mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week 48.

Intervention: AK111

placebo

Placebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.

Intervention: Placebo+AK111

Outcomes

Primary Outcomes

the response rate of ASAS20

Time Frame: week 16

Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 20% improvement (ASAS20) response at Week 16.

Secondary Outcomes

  • The response rate of ASAS20(baseline to week 52)
  • Change from baseline on the SF-36 PCS(baseline, week 16 and week 52)
  • The response rate of ASAS40(baseline to week 52)
  • Change from baseline on the ASDAS-CRP(baseline to week 52)
  • Change from baseline on the ASQoL scores(baseline, week 16 and week 52)
  • Treatment-emergent adverse events(baseline to week 52)
  • Serious adverse events(baseline to week 52)
  • Clinically significant examination results(baseline to week 52)
  • The response rate of ASAS5/6(baseline to week 52)
  • The response rate of ASAS40(week 16)

Study Sites (54)

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