A Clinical Study of JS005 in Patients With Ankylosing Spondylitis

Last updated: January 31, 2024
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

Ankylosing Spondylitis

Arthritis And Arthritic Pain

Bone Diseases

Treatment

Placebo(JS005)

Recombinant humanized IL-17A Monoclonal Antibody(JS005)

Clinical Study ID

NCT06250062
JS005-006-Ⅱ-AS
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subjects voluntarily particpate in this clinical study and sign the informed consentform.
  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 radiologicalevidence consistent with the Modified New York Classification Criteria for ankylosingspondylitis 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

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Active diseases that may confound the evaluation of JS005: other autoimmuneinflammatory diseases (including but not limited to systemic lupus erythematosus,rheumatoid arthritis, sarcoidosis, vasculitis, etc.) or chronic pain other thanankylosing spondylitis (including but not limited to fibromyalgia, osteoarthritis,etc.).
  3. Active inflammatory bowel disease within 6 months prior to randomization. 5. Recurrentanterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization.
  4. History or evidence of active or latent tuberculosis (TB), defined as a positiveinterferon gamma release assay (IGRA) or purified protein derivative (PPD) at the time ofscreening. 7. Positive hepatitis B virus test result 8. Prior exposure to JS005 or anyother biologic that directly targets IL-17 or the IL-17 receptor.
  5. use of >= 2 TNF-α inhibitors.

Study Design

Total Participants: 261
Treatment Group(s): 2
Primary Treatment: Placebo(JS005)
Phase: 2
Study Start date:
January 12, 2024
Estimated Completion Date:
October 08, 2025

Connect with a study center

  • Beijing Chao-yang Hospital,Capital Medical University

    Beijing, Beijing 100020
    China

    Site Not Available

  • Jilin Province People's Hospital

    Jilin, Changchun 130021
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian
    China

    Site Not Available

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian 361004
    China

    Site Not Available

  • Gansu Provincial Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Dongguan People's Hospital

    Dongguan, Guangdong 523018
    China

    Site Not Available

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510180
    China

    Site Not Available

  • Sun Yat-sen Memorial Hospital

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Site Not Available

  • Zhujiang Hospital of Southren Medical University

    Guangzhou, Guangdong 510280
    China

    Site Not Available

  • Huizhou Central People's Hospital

    Huizhou, Guangdong 516001
    China

    Site Not Available

  • Jieyang People's Hospital

    Jieyang, Guangdong 522000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Shantou University Medical College

    Shantou, Guangdong 515041
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Site Not Available

  • Shenzhen Second People's Hospital

    Shenzhen, Guangdong 518035
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473003
    China

    Active - Recruiting

  • Zhengzhou Central Hospital

    Zhengzhou, Henan 450001
    China

    Site Not Available

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan 412007
    China

    Site Not Available

  • The First Affiliated Hospital of Baotou Medical University

    Baotou, Inner Mongolia 014010
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010030
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Site Not Available

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu 221006
    China

    Site Not Available

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi 341000
    China

    Site Not Available

  • The First People's Hospital of Jiujiang City

    Jiujiang, Jiangxi 332000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Pingxiang People's Hospital

    Pingxiang, Jiangxi 337055
    China

    Site Not Available

  • Bethune First Hospital Of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou, Shandong 256603
    China

    Site Not Available

  • Shandong Provincial Hospital

    Jinan, Shandong 250021
    China

    Site Not Available

  • Zaozhuang Municipal Hospital

    Zaozhuang, Shandong 277100
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai 200003
    China

    Site Not Available

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • West China Hospital of Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Xinjiang Uygur Autonomous Region People's Hospital

    Ürümqi, Xinjiang 830001
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

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