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Ankylosing SpondylitisPhase 2NCT06250062

A Clinical Study of JS005 in Patients With Ankylosing Spondylitis

A Phase 2 study testing Recombinant humanized IL-17A Monoclonal Antibody（JS005） in people with Ankylosing Spondylitis, run by Shanghai Junshi Bioscience Co., Ltd. at 38 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 multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Recombinant humanized IL-17A Monoclonal Antibody（JS005）
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
265 participants
Where
38 sitesChina
Study dates
13 Jan 2024to 17 Jun 2026
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntarily particpate in this clinical study and sign the informed consent form.
  • Male and female patients aged 18-75 years at the time of screening (both inclusive)
  • Meet the diagnosis of active Ankylosing Spondylitis(AS), have a record of radiological evidence consistent with the Modified New York Classification Criteria for ankylosing spondylitis as revised in 1984 4. Diagnosis of active AS (active AS is defined as: BASDAI >= 4, total back pain score >=4, and BASDAI second question spinal pain score >=4)

Who cannot join

  • Pregnant or lactating women.
  • Active diseases that may confound the evaluation of JS005: other autoimmune inflammatory diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, vasculitis, etc.) or chronic pain other than ankylosing spondylitis (including but not limited to fibromyalgia, osteoarthritis, etc.).
  • 4. Active inflammatory bowel disease within 6 months prior to randomization. 5. Recurrent anterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization.
  • 6. History or evidence of active or latent tuberculosis (TB), defined as a positive interferon gamma release assay (IGRA) or purified protein derivative (PPD) at the time of screening. 7. Positive hepatitis B virus test result 8. Prior exposure to JS005 or any other biologic that directly targets IL-17 or the IL-17 receptor.
  • 9. use of >= 2 TNF-α inhibitors.

Trial locations and contacts

38 sites in 1 country.

38 sites in 1 country

China38 sites

  • The First Affiliated Hospital of Baotou Medical University

    Baotou, Inner Mongolia, 014010

  • Beijing Chao-yang Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100020

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256603

  • Bethune First Hospital Of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523018

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong, 510120

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510180

  • Zhujiang Hospital of Southren Medical University

    Guangzhou, Guangdong, 510280

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510630

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 010030

  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516001

  • Jieyang People's Hospital

    Jieyang, Guangdong, 522000

  • Jilin Province People's Hospital

    Jilin City, Changchun, 130021

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • The First People's Hospital of Jiujiang City

    Jiujiang, Jiangxi, 332000

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Nanyang Central Hospital

    Nanyang, Henan, 473003

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi, 337055

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai Municipality, 200003

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong, 515041

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong, 518035

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang, 830001

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian, 361004

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221006

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong, 277100

  • Zhengzhou Central Hospital

    Zhengzhou, Henan, 450001

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412007

Other trials in China

About this study

Official title: A Phase II, Randomized, Double-blind, Placebo-controlled , Multicenter Study to Evaluate the Preliminary Efficacy and Safety of Subcutaneous Injection of Recombinant Humanized Anti-IL-17A Monoclonal Antibody（JS005） in Adult Patients With Active Ankylosing Spondylitis

This is a multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis.

Being tested
Recombinant humanized IL-17A Monoclonal Antibody（JS005）, Placebo（JS005）
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • Recombinant humanized IL-17A Monoclonal Antibody（JS005）Drug

    Injection

  • Placebo（JS005）Drug

    Injection

Study groups in NCT06250062
Study groupRoleWhat they receive
Placebo（JS005）ExperimentalNot described
Receives: Drug: Placebo（JS005）
Recombinant humanized IL-17A Monoclonal Antibody（JS005）150mgExperimentalNot described
Receives: Drug: Recombinant humanized IL-17A Monoclonal Antibody（JS005）; Drug: Placebo（JS005）
Recombinant humanized IL-17A Monoclonal Antibody（JS005）300mgExperimentalNot described
Receives: Drug: Recombinant humanized IL-17A Monoclonal Antibody（JS005）; Drug: Placebo（JS005）

What is being measured

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

  1. Assessment of SpondyloArthritis International Society criteria (ASAS）40

    Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 16.

    Measured: 16 weeks

Secondary outcomes (10)

  1. Assessment of SpondyloArthritis International Society criteria (ASAS）40

    Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 32.

    Measured: 32 weeks

  2. Assessment of SpondyloArthritis International Society criteria (ASAS）20

    Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）20 response criteria at weeks 16 and 32.

    Measured: 16 weeks and 32 weeks

  3. Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP)

    Changes in ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) from baseline at weeks 16 and 32

    Measured: 16 weeks and 32 weeks

  4. Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1

    Proportion of subjects with ASDAS-CRP less than 2.1 at weeks 16 and 32.

    Measured: 16 weeks and 32 weeks

  5. Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 1.1

    The proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) change of 1.1 or greater from baselinat weeks 16 and 32.

    Measured: 16 weeks and 32 weeks

  6. Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 2.0

    The proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) change of 2.0 or greater from baselinat weeks 16 and 32.

    Measured: 16 weeks and 32 weeks

  7. Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) < 1.3

    Proportion of subjects with Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) less than 1.3 at weeks 16 and 32

    Measured: 16 weeks and 32 weeks

  8. Assessment of SpondyloArthritis International Society criteria (ASAS) partial remission

    Proportion of subjects who achieved partial remission of Assessment of SpondyloArthritis International Society criteria (ASAS) at weeks 16 and 32

    Measured: 16 weeks and 32 weeks

  9. Pharmacokinetic(PK)

    To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005

    Measured: 40 weeks

  10. Immunogenicity

    The immunogenicity of JS005 was assessed by the positive incidence and titer of drug-resistant antibodies (ADA) and the incidence of neutralizing antibodies (NAb), if applicable

    Measured: 40 weeks

Timeline

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

  1. First posted8 Feb 2024
  2. Study start13 Jan 2024
  3. Primary completion14 Jan 2024
  4. Study completion17 Jun 2026

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
265 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06250062
Sponsor's protocol ID
JS005-006-Ⅱ-AS
Status last verified
Jul 2026
First submitted
9 Jan 2024
Last updated
20 Jul 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 2 study testing Recombinant humanized IL-17A Monoclonal Antibody（JS005） in people with Ankylosing Spondylitis, run by Shanghai Junshi Bioscience Co., Ltd. at 38 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 3 inclusion and 5 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 20 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 38 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. 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 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?

Assessment of SpondyloArthritis International Society criteria (ASAS）40 (time frame: 16 weeks). 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 NCT06250062.

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 20 Jul 2026.

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