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Non-radiographic Axial SpondyloarthritisPhase 2NCT05242588

Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA

A Phase 2 study testing JS005 in people with Non-radiographic Axial Spondyloarthritis, run by Shanghai Junshi Bioscience Co., Ltd. at 25 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active non-radiographic axial spondyloarthritis(nr-axSpA). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Non-radiographic Axial Spondyloarthritis
What is being tested?
JS005
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
23 participants
Where
25 sitesChina
Study dates
31 Dec 2021to 30 Jun 2023
Phase
Phase 2
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
  • 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.
  • 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).
  • Voluntarily participate in this clinical trial and sign the informed consent form.
  • 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.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Unable or unwilling to undergo MRI.
  • Previous exposure to JS005 or any other biologic drug directly targeting IL-17 or IL-17 receptor.
  • Have taken high potency analgesics (e.g., opiates of methadone, hydromorphone, morphine) within 2 weeks prior to randomization.
  • Previous treatment with any intra-articular injection (e.g., glucocorticoids) within 4 weeks prior to randomization.
  • Previous treatment with any biological immunomodulating agents other than the TNFα inhibitors.
  • Treatment with JAK inhibitor agents within 8 weeks prior to randomization and unwilling to discontinue during the study.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan, 361001

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 600041

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116023

  • Sun Yat-sen Memorial Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Nanfang Hospital of Nanfang Medical University

    Guangzhou, Guangdong, 510515

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

    Hangzhou, Zhejiang, 450052

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The Affilated Hospital of Inner Mongdlia Medical University

    Hohhot, Inner Mongolia, 100000

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 030001

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 250063

  • North Sichuan Medical College Affiliated Hospital

    Nanchong, Sichuan, 637000

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • Shantou University Medical Collge No.1 Affiliated Hospital

    Shantou, Guangdong, 515041

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shengjing Hospital of China medical University

    Shenyang, Liaoning, 110004

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518001

  • Pking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 650032

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300041

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi, Xinjiang, 8300001

  • Tongji Hospital,Tongji Medical College of HUST

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 410011

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 361001

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase II, Multicenter Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetics of Subcutaneous JS005 in Chinese Adults With Active Non-radiographic Axial Spondyloarthritis

The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active non-radiographic axial spondyloarthritis(nr-axSpA). Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese nr-axSpA patients in terms of ASAS 40 response rate at Week 16 as well as safety profile will be provided by the study .

Read the detailed description

This is a randomized, double-blind, placebo-controlled study. Approximately 120 patients who meet the eligibility criteria will be randomized to one of three treatment cohorts (JS005 150 mg, 300 mg, 450mg in a ratio of 1:1:1),then using secondary randomization method, 40 patients in each group will be randomized in a 3: 1 ratio to receive investigational product or placebo.

  1. JS005 150mg Cohort: JS005 150 mg or placebo treatment(JS005:Placrbo=3:1) s.c. prefilled syringe (PFS) on Week 0, 1, 2, 3, 4,8 and 12
  2. JS005 300mg Cohort: JS005 300 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 3 .JS005 450mg Cohort: JS005 450 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.
Being tested
JS005, Placebo
Medical subject headings
Non-Radiographic Axial Spondyloarthritis

What participants receive

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

  • JS005Biological

    Also called Recombinant humanized anti-IL-17A monoclonal antibody injection

    30 subjectes in JS005 150mg chort, JS005 300mg chort, and JS005 450mg chort receive JS005 150mg, JS005 300mg and JS005 450mg subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).

  • PlaceboBiological

    10 subjects in JS005 150mg chort, JS005 300mg chort, and JS005 450mgchort receive the placebo subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).

Study groups in NCT05242588
Study groupRoleWhat they receive
JS005 150 mgExperimental30 patients will be enrolled in this arm.
Receives: Biological: JS005
Placebo 150 mgPlacebo comparator10 patients will be enrolled in this arm.
Receives: Biological: Placebo
JS005 300 mgExperimental30 patients will be enrolled in this arm.
Receives: Biological: JS005
Placebo 300 mgPlacebo comparator10 patients will be enrolled in this arm.
Receives: Biological: Placebo
JS005 450 mgExperimental30 patients will be enrolled in this arm.
Receives: Biological: JS005
Placebo 450Placebo comparator10 patients will be enrolled in this arm.
Receives: Biological: Placebo

What is being measured

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

  1. The proportion of nr-axSpA patients meeting the Assessment of Spondylo Arthritis international Society (ASAS) 40 response criteria

    at the end of treatment Week 16 .

    Measured: From week 0 to week 16

Secondary outcomes (12)

  1. ASAS20 response criteria

    The proportion of patients meeting the ASAS20 response criteria at the end of treatment Week 16

    Measured: From week 0 to week 16

  2. ASAS 5/6 response criteria

    The proportion of patients meeting the ASAS 5/6 response criteria at the end of treatment Week 16;

    Measured: From week 0 to week 16

  3. High-sensitivity C-reactive protein (hsCRP)

    The change from baseline in high-sensitivity C-reactive protein (hsCRP) at the end of treatment Week 16

    Measured: From week 0 to week 16

  4. The inflammation score of the sacroiliac joint

    The change from baseline in the inflammation score of the sacroiliac joint by MRI at the end of treatment Week 16

    Measured: From week 0 to week 16

  5. Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)

    The change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at the end of treatment Week 16;

    Measured: From week 0 to week 16

  6. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    The change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the end of treatment Week 16

    Measured: From week 0 to week 16

  7. Bath Ankylosing Spondylitis Functional Index (BASFI)

    The change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at the end of treatment Week 16

    Measured: From week 0 to week 16

  8. Bath Ankylosing Spondylitis Disease Metrology Index (BASMI)

    The change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at the end of treatment Week 16

    Measured: From week 0 to week 16

  9. Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)

    The change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at the end of treatment Week 16

    Measured: From week 0 to week 16

  10. The patient's global assessment of disease activity

    Numeric Rating Scale (NRS, ranging from 0 not active to 10 very active) will be used to evaluate the patient's global assessment of disease activity. Patient will be asked by one question: How active was your spondylitis on average during the last week？

    Measured: From week 0 to week 16

  11. The patient's assessment of inflammatory back pain intensity

    NRS(ranging from 0 no pain to 10 most severe pain) will be used to assess the patient's inflammatory back pain intensity. The assessment is based on two questions: "Based on your assessment, please indicate How much pain of your spine due to AS do you have ?" and "Based on your assessment, please specify How much pain of your spine due to AS do you have at night?" When responding, the subject is to consider the average amount of pain in the last week.

    Measured: From week 0 to week 16

  12. ASAS partial remission criteria

    The proportion of patients meeting ASAS partial remission criteria at the end of treatment Week 16

    Measured: From week 0 to week 16

Timeline

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

  1. First posted16 Feb 2022
  2. Study start31 Dec 2021
  3. Primary completion13 Mar 2023
  4. Study completion30 Jun 2023

Why it stopped: Company research and development strategy adjustment, decided to study temporarily

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05242588
Sponsor's protocol ID
JS005-004-II-nr-axSpA
Status last verified
Jul 2026
First submitted
30 Nov 2021
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JS005 in people with Non-radiographic Axial Spondyloarthritis, run by Shanghai Junshi Bioscience Co., Ltd. at 25 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 was stopped early (reason given: Company research and development strategy adjustment, decided to study temporarily). Results are not available in the source record.

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 proportion of nr-axSpA patients meeting the Assessment of Spondylo Arthritis international Society (ASAS) 40 response criteria (time frame: From week 0 to 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 NCT05242588.

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 21 Jul 2026.

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