Recombinant humanized IL-17A Monoclonal Antibody(JS005)
DrugInjection
NCT Number: NCT06250062
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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Notify Me18 year–75 year
All sexes
Interventional
Phase 2
Beijing Chao-yang Hospital,Capital Medical University, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Injection
Injection
Time frame: 16 weeks
Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS)40 response criteria at week 16.
Time frame: 32 weeks
Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS)40 response criteria at week 32.
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.
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
Time frame: 16 weeks and 32 weeks
Proportion of subjects with ASDAS-CRP less than 2.1 at weeks 16 and 32.
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.
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.
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
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
Time frame: 40 weeks
To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005
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
Shanghai Junshi Bioscience Co., Ltd.
Other
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
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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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