Evaluating JS005 for treating active ankylosing spondylitis

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 study is testing a new treatment called JS005 to see if it can help adults with active ankylosing spondylitis feel better compared to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 261 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. (other)
• Locations: 38 sites (Beijing, Beijing and 37 other locations)
• Trial ID: NCT06250062 on ClinicalTrials.gov

What this trial studies

This clinical study is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II trial involving 261 adults diagnosed with active ankylosing spondylitis. The primary aim is to assess the efficacy and safety of JS005, a recombinant humanized IL-17A monoclonal antibody, compared to a placebo. Participants will be monitored for improvements in their condition based on specific clinical criteria. The study seeks to provide insights into a new treatment option for this chronic inflammatory disease.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of active ankylosing spondylitis meeting specific clinical criteria.

Not a fit: Patients with other autoimmune inflammatory diseases or chronic pain conditions unrelated to ankylosing spondylitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from active ankylosing spondylitis.

How similar studies have performed: Other studies have explored treatments targeting IL-17A in ankylosing spondylitis, showing promising results, but this specific approach with JS005 is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing and 37 other locations

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

Study contacts

• Principal investigator: Huji Xu, PhD — Shanghai Changzheng Hospital
• Study coordinator: Jiexin Hu

Conditions: Ankylosing Spondylitis