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
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.
Investigators
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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