Ankylosing Spondylitis
Conditions
Brief 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.
Interventions
DRUGRecombinant humanized IL-17A Monoclonal Antibody（JS005）
Injection
DRUGPlacebo（JS005）
Injection
Sponsors
Shanghai Junshi Bioscience Co., Ltd.
Sponsor GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects voluntarily particpate in this clinical study and sign the informed consent form. 2. Male and female patients aged 18-75 years at the time of screening (both inclusive) 3. 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
1. Pregnant or lactating women. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of SpondyloArthritis International Society criteria (ASAS）40 | 16 weeks | Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of SpondyloArthritis International Society criteria (ASAS）40 | 32 weeks | Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 32. |
| Assessment of SpondyloArthritis International Society criteria (ASAS）20 | 16 weeks and 32 weeks | Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）20 response criteria at weeks 16 and 32. |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) | 16 weeks and 32 weeks | Changes in ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) from baseline at weeks 16 and 32 |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1 | 16 weeks and 32 weeks | Proportion of subjects with ASDAS-CRP less than 2.1 at weeks 16 and 32. |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 1.1 | 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. |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 2.0 | 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. |
| Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) < 1.3 | 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 |
| Assessment of SpondyloArthritis International Society criteria (ASAS) partial remission | 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 |
| Pharmacokinetic(PK) | 40 weeks | To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005 |
| Immunogenicity | 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHuji Xu, PhD
Shanghai Changzheng Hospital
Outcome results
None listed