A Clinical Study of JS005 in Patients With Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06250062
• Other study ID #: JS005-006-?-AS
• Status: Recruiting
• Phase: Phase 2
• Start date: January 12, 2024
• Est. completion date: October 8, 2025

Study information

• Verified date: January 2024
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: Jiexin Hu
• Phone: 13521183167
• Email: jiexin_hu[@]junshipharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 261
• Est. completion date: October 8, 2025
• Est. primary completion date: February 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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-a inhibitors.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Baotou Medical University	Baotou	Inner Mongolia
China	Beijing Chao-yang Hospital,Capital Medical University	Beijing	Beijing
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Bethune First Hospital Of Jilin University	Changchun	Jilin
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	Dongguan People's Hospital	Dongguan	Guangdong
China	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangxi
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southren Medical University	Guangzhou	Guangdong
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia
China	Huizhou Central People's Hospital	Huizhou	Guangdong
China	Jieyang People's Hospital	Jieyang	Guangdong
China	Jilin Province People's Hospital	Jilin	Changchun
China	Shandong Provincial Hospital	Jinan	Shandong
China	The First People's Hospital of Jiujiang City	Jiujiang	Jiangxi
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Nanyang Central Hospital	Nanyang	Henan
China	Pingxiang People's Hospital	Pingxiang	Jiangxi
China	Shanghai Changzheng Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Xinjiang Uygur Autonomous Region People's Hospital	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
China	Zaozhuang Municipal Hospital	Zaozhuang	Shandong
China	Zhengzhou Central Hospital	Zhengzhou	Henan
China	Zhuzhou Central Hospital	Zhuzhou	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.	Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	16 weeks
Secondary	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.	32 weeks
Secondary	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.	16 weeks and 32 weeks
Secondary	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	16 weeks and 32 weeks
Secondary	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.	16 weeks and 32 weeks
Secondary	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.	16 weeks and 32 weeks
Secondary	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.	16 weeks and 32 weeks
Secondary	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	16 weeks and 32 weeks
Secondary	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	16 weeks and 32 weeks
Secondary	Pharmacokinetic(PK)	To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005	40 weeks
Secondary	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	40 weeks