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Completed

NCT Number: NCT06250062

A Clinical Study of JS005 in Patients With 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Chao-yang Hospital,Capital Medical University, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.).
  • 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.
  • 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.
  • use of >= 2 TNF-α inhibitors.

Treatment and study plan

Recombinant humanized IL-17A Monoclonal Antibody(JS005)

Drug

Injection

Placebo(JS005)

Drug

Injection

Primary outcomes

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

    Time frame: 16 weeks

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

Secondary outcomes

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

    Time frame: 32 weeks

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

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

    Time frame: 16 weeks and 32 weeks

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

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

    Time frame: 16 weeks and 32 weeks

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

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

    Time frame: 16 weeks and 32 weeks

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

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

    Time frame: 16 weeks and 32 weeks

    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.

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

    Time frame: 16 weeks and 32 weeks

    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.

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

    Time frame: 16 weeks and 32 weeks

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

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

    Time frame: 16 weeks and 32 weeks

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

  9. Pharmacokinetic(PK)

    Time frame: 40 weeks

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

  10. Immunogenicity

    Time frame: 40 weeks

    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

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Collaborators

  • Sponsor GmbH

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Feb 8, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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