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Ankylosing SpondylitisPhase 3NCT06378697

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

A Phase 3 study testing AK111 in people with Ankylosing Spondylitis, run by Akeso at 60 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
AK111
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
510 participants
Where
60 sitesChina
Study dates
22 Nov 2023to 7 Nov 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

60 sites in 1 country.

60 sites in 1 country

China60 sites

  • 1034-Affiliated Hospital of Hebei University

    Baoding, Hebei

  • 1001-Peking University Third Hospital

    Beijing, Beijing Municipality

  • 1002-Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality

  • 1042-Peking University Shougang Hospital

    Beijing, Beijing Municipality

  • 1061-Beijing Tiantan Hospital

    Beijing, Beijing Municipality

  • 1006-The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

  • 1044-Jilin Provincial People's Hospital

    Changchun, Jilin

  • 1017-Changzhou NO.2 People's Hospital

    Changzhou, Jiangsu

  • 1010-West China Hospital,Sichuan University

    Chengdu, Sichuan

  • 1047-The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi

  • 1005-Nanfang Hospital

    Guangzhou, Guangdong

  • 1025-Guangzhou First People's Hospital

    Guangzhou, Guangdong

  • 1060-The First Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi

  • 1022-The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

  • 1038-Anhui Provincial Hospital

    Hefei, Anhui

  • 1031-The First Affiliated Hospital of University of South China

    Hengyang, Hunan

  • 1040- Huzhou Third People's Hospital

    Huzhou, Zhejiang

  • 1030-Jieyang People's Hospital

    Jieyang, Guangdong

  • 1028- Jining First People's Hospital

    Jining, Shandong

  • 1058-Affiliated Hospital of Jining Medical University

    Jining, Shandong

  • 1012-Hebei Petro China Central Hospital

    Langfang, Hebei

  • 1027-Lanzhou University Second Hospital

    Lanzhou, Gansu

  • 1037-The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu

  • 1054-Linfen Central Hospital

    Linfen, Shanxi

  • 1019-Linyi City People Hospital

    Linyi, Shandong

  • 1024-Liuzhou People's Hospital

    Liuzhou, Guangxi

  • 1045-The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan

  • 1048-Mianyang Central Hospital

    Mianyang, Sichuan

  • 1020-The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • 1039-The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • 1041-Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan

  • 1004-Zhongda Hospital Southeast University

    Nanjing, Jiangsu

  • 1007-Nanjing Drum Tower Hospital

    Nanjing, Jiangsu

  • 1036-Jiangsu Province Hospital

    Nanjing, Jiangsu

  • 1021-The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi

  • 1057-The Second Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

  • 1018-Affiliated Hospital of Nantong University

    Nantong, Jiangsu

  • 1053-Nanyang Central Hospital

    Nanyang, Henan

  • 1046-Pingxiang People's Hospital

    Pingxiang, Jiangxi

  • 1062-Qilu Hospital (Qingdao), Shandong University

    Qingdao, Shandong

  • 1033-The First Hospital of Qiqihar

    Qiqihar, Heilongjiang

  • 1008-The Seventh Affiliated Hospital, Sun Yat-sen University

    Shenzhen, Guangdong

  • 1026-Shenzhen People's Hospital

    Shenzhen, Guangdong

  • 1029-Hebei General Hospital

    Shijiazhuang, Hebei

  • 1051-Shiyan People's Hospital

    Shiyan, Hubei

  • 1009-Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • 1015-Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang

  • 1059-Tianjin First Central Hospital

    Tianjin, Tianjin Municipality

  • 1023-The People's Hospital of Xinjiang Uyghur Autonomous Region

    Ürümqi, Xinjiang

  • 1055-Weifang People's Hospital

    Weifang, Shandong

  • 1050-The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

  • 1035-Wuxi People's Hospital

    Wuxi, Jiangsu

  • 1049-The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • 1013-Xuzhou Central Hospital

    Xuzhou, Jiangsu

  • 1032-Yueyang Central Hospital

    Yueyang, Hunan

  • 1043-Yuncheng Central Hospital

    Yuncheng, Shanxi

  • 1016-Zaozhuang Municipal Hospital

    Zaozhuang, Shandong

  • 1014-Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu

  • 1056-Zhongshan Traditional Chinese Medicine Hospital

    Zhongshan, Guangdong

  • 1011-Zhuzhou Central Hospital

    Zhuzhou, Hunan

Other trials in China

About this study

Official title: 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

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.

Read the 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.

Being tested
AK111, Placebo+AK111
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AK111Drug

    Drug: AK111 subcutaneous injection at week 0,1, 4 and 4-weekly thereafter until week 48.

  • Placebo+AK111Drug

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

Study groups in NCT06378697
Study groupRoleWhat they receive
AK111ExperimentalAK111 150 mg will be administered by subcutaneous injection at Week 0, 1 and 4 , followed by dosing every 4 weeks until Week 48.
Receives: Drug: AK111
placeboPlacebo comparatorPlacebo+AK111 placebo subcutaneous injection at week 0,1, 4,8 and 12 follow AK111 4-weekly thereafter until week 48.
Receives: Drug: Placebo+AK111

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the response rate of ASAS20

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

    Measured: week 16

Secondary outcomes (10)

  1. The response rate of ASAS40

    Percentage of subjects who achieve Assessment of SpondyloArthritis International Society 40% improvement (ASAS40) response at Week 16.

    Measured: week 16

  2. The response rate of ASAS20

    Percentage of subjects who achieve ASAS20 response throughout the clinical trial

    Measured: baseline to week 52

  3. The response rate of ASAS40

    Percentage of subjects who achieve ASAS40 response throughout the clinical trial

    Measured: baseline to week 52

  4. The response rate of ASAS5/6

    Percentage of subjects who achieve ≥20% improvement in five of the six domains (ASAS5/6) response throughout the clinical trial

    Measured: baseline to week 52

  5. Change from baseline on the ASDAS-CRP

    Change from baseline on the Ankylosing Spondylitis Disease Activity Score based on CRP (ASDAS-CRP) at each visit from baseline

    Measured: baseline to week 52

  6. Change from baseline on the SF-36 PCS

    Change from baseline on the Short-Form 36 physical component score(SF-36 PCS) at each visit from baseline

    Measured: baseline, week 16 and week 52

  7. Change from baseline on the ASQoL scores

    Change from baseline on the Ankylosing Spondylitis Quality of Life (ASQoL) scores at each visit from baseline

    Measured: baseline, week 16 and week 52

  8. Treatment-emergent adverse events

    Percentage of subjects with treatment-emergent adverse events (TEAEs) during the study

    Measured: baseline to week 52

  9. Serious adverse events

    Percentage of subjects with treatment-emergent serious adverse events (SAEs) during the study

    Measured: baseline to week 52

  10. Clinically significant examination results

    Recording clinically significant examination results

    Measured: baseline to week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2024
  2. Study start22 Nov 2023
  3. Primary completion19 Feb 2025
  4. Study completion7 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06378697
Sponsor's protocol ID
AK111-303
Status last verified
Mar 2026
First submitted
1 Mar 2024
Last updated
16 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AK111 in people with Ankylosing Spondylitis, run by Akeso at 60 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 60 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the response rate of ASAS20 (time frame: week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06378697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

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