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Experimental antibody aims to quiet spinal inflammation without X-Ray damage

NCT ID NCT05242588

Disease control Sponsor: Shanghai Junshi Bioscience Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This phase 2 trial tests an experimental drug called JS005 in Chinese adults with active non-radiographic axial spondyloarthritis, a form of inflammatory back pain that does not yet show damage on X-rays. Participants receive either a low, medium, or high dose of JS005 or a placebo as a series of injections over 16 weeks. The study measures how well the drug reduces symptoms and inflammation, and checks for side effects.

What this could mean

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

Active substance
an experimental anti-IL-17A monoclonal antibody called JS005
What this could lead to
If successful, JS005 could offer a new treatment option for people with non-radiographic axial spondyloarthritis, reducing pain and inflammation.
What could go wrong
This is an early phase 2 trial with only 23 participants, so results may not apply to everyone. The drug may not work better than placebo or could have side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

23 people

The number who actually took part.

Started

Dec 2021

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

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: 1. Patients who do not meet the modified New York criteria for AS in 1984; Meet the 2009 axSpA classification criteria recommended by International Assessment Society of Axial Spondyloarthritis (ASAS): inflammatory back pain for at least 3 months; Age of onset \< 45 years; Sacroiliitis on MRI with≥ 1 axial spondyloarthritis features or HLA-B27 positive with ≥ 2 SpA features (MRI and X-ray of sacroiliac joint as confirmed by central readers). 2. Objective signs of inflammation at screening: active inflammation of the sacroiliac joints on MRI and/or high sensitivity C-reactive protein (hsCRP) \> upper limit of normal without other diagnoses to explain the MRI results or elevated hsCRP. 3. Active axSpA at screening and baseline: assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10 scale) and spinal pain ≥ 4 (according to the 0-10 NRS scale, BASDAI question #2). 4. Voluntarily participate in this clinical trial and sign the informed consent form. 5. Male or female aged between 18 and 65 years (both inclusive) at the time of signing informed consent. Female subjects of childbearing age are required to have a confirmed negative result of urine and/or serum pregnancy test performed within 3 days before randomization and agree to use reliable contraceptive measures during the study; Male subjects and their female partners of childbearing age must agree to use reliable contraception during the study. 6. Patients meet at least one of the following: 1) have an inadequate or ineffective response to NSAIDs, 2) have been intolerant to at least one dose of NSAIDs, 3) have contraindications to NSAIDs therapy. Inadequate or ineffective response to NSAIDs is defined as no remission after continuous treatment with standard doses of at least 2 NSAIDs for a total of no less than 4 weeks and no less than 2 weeks for each NSAID. 7. Patients regularly taking NSAIDs as part of their AS therapy are required to maintain a stable dose for at least 2 weeks prior to randomization. 8. Patients using tumor necrosis factor α (TNFα) inhibitors must have experienced an inadequate response to the standard treatment dose for at least 3 months, or have been intolerant to TNFα inhibitors. Exclusion Criteria: 1. Unable or unwilling to undergo MRI. 2. Previous exposure to JS005 or any other biologic drug directly targeting IL-17 or IL-17 receptor. 3. Have taken high potency analgesics (e.g., opiates of methadone, hydromorphone, morphine) within 2 weeks prior to randomization. 4. Previous treatment with any intra-articular injection (e.g., glucocorticoids) within 4 weeks prior to randomization. 5. Previous treatment with any biological immunomodulating agents other than the TNFα inhibitors. 6. Treatment with JAK inhibitor agents within 8 weeks prior to randomization and unwilling to discontinue during the study.

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Conditions

The condition(s) this trial relates to.

Non-Radiographic Axial Spondyloarthritis spondyloarthropathy

As listed by the trial registrant

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

Non-radiographic axial spondyloarthritis

Contacts and locations

Locations

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001, China

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 250063, China

  • First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 650032, China

  • Nanfang Hospital of Nanfang Medical University

    Guangzhou, Guangdong, 510515, China

  • North Sichuan Medical College Affiliated Hospital

    Nanchong, Sichuan, 637000, China

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 8300001, China

  • Pking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 030001, China

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003, China

  • Shantou University Medical Collge No.1 Affiliated Hospital

    Shantou, Guangdong, 515041, China

  • Shengjing Hospital of China medical University

    Shenyang, Liaoning, 110004, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518001, China

  • Sun Yat-sen Memorial Sun Yat-sen University

    Guangzhou, Guangdong, 510120, China

  • The Affilated Hospital of Inner Mongdlia Medical University

    Hohhot, Inner Mongolia, 100000, China

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 410011, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 361001, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023, China

  • The Second Affiliated Hospital of Zhejiang University,School of Medicine

    Hangzhou, Zhejiang, 450052, China

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410013, China

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 361001, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300041, China

  • Tongji Hospital,Tongji Medical College of HUST

    Wuhan, Hubei, 430030, China

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 600041, China

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