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New shot could ease back pain for ankylosing spondylitis patients

NCT ID NCT06378697

Disease control Sponsor: Akeso Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called AK111 in 510 adults with active ankylosing spondylitis, a type of arthritis that causes back pain and stiffness. Participants received either AK111 or a placebo as a shot under the skin over 48 weeks. The main goal was to see if AK111 improves symptoms by at least 20% after 16 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AK111 (a drug given as a shot under the skin)
What this could lead to
If it works, this could offer a new treatment option to reduce pain and stiffness for people with active ankylosing spondylitis.
What could go wrong
This is a completed Phase 3 trial, but results are not yet public. The drug may not work better than placebo, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

510 people

The number who actually took part.

Started

Nov 2023

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankylosing spondylitis

Contacts and locations

Locations

  • 1001-Peking University Third Hospital

    Beijing, Beijing Municipality, China

  • 1002-Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, China

  • 1004-Zhongda Hospital Southeast University

    Nanjing, Jiangsu, China

  • 1005-Nanfang Hospital

    Guangzhou, Guangdong, China

  • 1006-The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, China

  • 1007-Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

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

    Shenzhen, Guangdong, China

  • 1009-Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • 1010-West China Hospital,Sichuan University

    Chengdu, Sichuan, China

  • 1011-Zhuzhou Central Hospital

    Zhuzhou, Hunan, China

  • 1012-Hebei Petro China Central Hospital

    Langfang, Hebei, China

  • 1013-Xuzhou Central Hospital

    Xuzhou, Jiangsu, China

  • 1014-Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, China

  • 1015-Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, China

  • 1016-Zaozhuang Municipal Hospital

    Zaozhuang, Shandong, China

  • 1017-Changzhou NO.2 People's Hospital

    Changzhou, Jiangsu, China

  • 1018-Affiliated Hospital of Nantong University

    Nantong, Jiangsu, China

  • 1019-Linyi City People Hospital

    Linyi, Shandong, China

  • 1020-The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

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

    Nanning, Guangxi, China

  • 1022-The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan, China

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

    Ürümqi, Xinjiang, China

  • 1024-Liuzhou People's Hospital

    Liuzhou, Guangxi, China

  • 1025-Guangzhou First People's Hospital

    Guangzhou, Guangdong, China

  • 1026-Shenzhen People's Hospital

    Shenzhen, Guangdong, China

  • 1027-Lanzhou University Second Hospital

    Lanzhou, Gansu, China

  • 1028- Jining First People's Hospital

    Jining, Shandong, China

  • 1029-Hebei General Hospital

    Shijiazhuang, Hebei, China

  • 1030-Jieyang People's Hospital

    Jieyang, Guangdong, China

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

    Hengyang, Hunan, China

  • 1032-Yueyang Central Hospital

    Yueyang, Hunan, China

  • 1033-The First Hospital of Qiqihar

    Qiqihar, Heilongjiang, China

  • 1034-Affiliated Hospital of Hebei University

    Baoding, Hebei, China

  • 1035-Wuxi People's Hospital

    Wuxi, Jiangsu, China

  • 1036-Jiangsu Province Hospital

    Nanjing, Jiangsu, China

  • 1037-The Second People's Hospital of Lianyungang

    Lianyungang, Jiangsu, China

  • 1038-Anhui Provincial Hospital

    Hefei, Anhui, China

  • 1039-The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, China

  • 1040- Huzhou Third People's Hospital

    Huzhou, Zhejiang, China

  • 1041-Affiliated Hospital of North Sichuan Medical College

    Nanchong, Sichuan, China

  • 1042-Peking University Shougang Hospital

    Beijing, Beijing Municipality, China

  • 1043-Yuncheng Central Hospital

    Yuncheng, Shanxi, China

  • 1044-Jilin Provincial People's Hospital

    Changchun, Jilin, China

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

    Luoyang, Henan, China

  • 1046-Pingxiang People's Hospital

    Pingxiang, Jiangxi, China

  • 1047-The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi, China

  • 1048-Mianyang Central Hospital

    Mianyang, Sichuan, China

  • 1049-The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, China

  • 1050-The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • 1051-Shiyan People's Hospital

    Shiyan, Hubei, China

  • 1053-Nanyang Central Hospital

    Nanyang, Henan, China

  • 1054-Linfen Central Hospital

    Linfen, Shanxi, China

  • 1055-Weifang People's Hospital

    Weifang, Shandong, China

  • 1056-Zhongshan Traditional Chinese Medicine Hospital

    Zhongshan, Guangdong, China

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