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Evaluating AK111 for treating active ankylosing spondylitis

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

Phase 3 Interventional Akeso · NCT06378697

This study is testing a new treatment called AK111 to see if it can help people with active ankylosing spondylitis feel better compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment510 (estimated)
Ages18 Years and up
SexAll
SponsorAkeso Industry-sponsored
Drugs / interventionsNatalizumab, secukinumab, ixekizumab, methotrexate, prednisone
Locations54 sites (Bengbu, Anhui and 53 other locations)
Trial IDNCT06378697 on ClinicalTrials.gov

What this trial studies

This phase III clinical study is designed to assess the efficacy and safety of AK111 in patients with active ankylosing spondylitis. It involves a randomized, double-blind, placebo-controlled approach, divided into three parts: screening, placebo control, and long-term treatment follow-up. The total duration of the study is 61 weeks, during which participants will receive either AK111 or a placebo. The study aims to determine how well AK111 alleviates symptoms compared to standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed active ankylosing spondylitis who have not adequately responded to previous NSAID treatments.

Not a fit: Patients who have not been diagnosed with ankylosing spondylitis or those who have not responded to AK111 in previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief and improved quality of life for patients suffering from active ankylosing spondylitis.

How similar studies have performed: Previous studies on similar biologic treatments for ankylosing spondylitis have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion 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≥ 4.
* 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.

Where this trial is running

Bengbu, Anhui and 53 other locations

+4 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ankylosing Spondylitis
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.