A Clinical Study of JS005 in Patients With Ankylosing Spondylitis

January 31, 2024 updated by: Shanghai Junshi Bioscience Co., Ltd.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

261

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100020
        • Not yet recruiting
        • Beijing Chao-Yang Hospital,Capital medical university
        • Contact:
    • Changchun
      • Jilin, Changchun, China, 130021
        • Not yet recruiting
        • Jilin Province People's Hospital
        • Contact:
    • Fujian
      • Xiamen, Fujian, China
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
      • Xiamen, Fujian, China, 361004
        • Not yet recruiting
        • Zhongshan Hospital Xiamen University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Gansu Provincial Hospital
        • Contact:
    • Guangdong
      • Dongguan, Guangdong, China, 523018
        • Not yet recruiting
        • Dongguan People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510630
        • Not yet recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
      • Guangzhou, Guangdong, China, 510180
        • Not yet recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510280
        • Not yet recruiting
        • Zhujiang Hospital of Southren Medical University
        • Contact:
      • Huizhou, Guangdong, China, 516001
        • Not yet recruiting
        • Huizhou Central People's Hospital
        • Contact:
      • Jieyang, Guangdong, China, 522000
        • Recruiting
        • Jieyang People's Hospital
        • Contact:
      • Shantou, Guangdong, China, 515041
        • Not yet recruiting
        • The First Affiliated Hospital of Shantou University Medical College
        • Contact:
      • Shenzhen, Guangdong, China, 518020
        • Not yet recruiting
        • ShenZhen People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518035
        • Not yet recruiting
        • Shenzhen Second People's Hospital
        • Contact:
    • Henan
      • Nanyang, Henan, China, 473003
        • Recruiting
        • Nanyang Central Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450001
        • Not yet recruiting
        • Zhengzhou Central Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Not yet recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Zhuzhou, Hunan, China, 412007
        • Not yet recruiting
        • ZhuZhou Central Hospital
        • Contact:
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
        • Not yet recruiting
        • The First Affiliated Hospital of Baotou Medical University
        • Contact:
      • Hohhot, Inner Mongolia, China, 010030
        • Not yet recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221006
        • Not yet recruiting
        • Xuzhou Central Hospital
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Not yet recruiting
        • First Affiliated hospital of Gannan Medical University
        • Contact:
      • Jiujiang, Jiangxi, China, 332000
        • Not yet recruiting
        • The First People's Hospital of Jiujiang City
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Pingxiang, Jiangxi, China, 337055
        • Not yet recruiting
        • Pingxiang People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • Bethune First Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Contact:
    • Shandong
      • Binzhou, Shandong, China, 256603
        • Not yet recruiting
        • Binzhou Medical University Hospital
        • Contact:
      • Jinan, Shandong, China, 250021
        • Not yet recruiting
        • Shandong Provincial Hospital
        • Contact:
      • Zaozhuang, Shandong, China, 277100
        • Not yet recruiting
        • Zaozhuang Municipal Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Not yet recruiting
        • Shanghai Changzheng Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • Second Hospital of Shanxi Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • West China Hospital of Sichuan University
        • Contact:
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830001
        • Not yet recruiting
        • Xinjiang Uygur Autonomous Region People's Hospital
        • Contact:
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Not yet recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo（JS005）
Drug: Placebo（JS005）
Injection
Experimental: Recombinant humanized IL-17A Monoclonal Antibody（JS005）150mg
Drug: Placebo（JS005）
Injection
Drug: Recombinant humanized IL-17A Monoclonal Antibody（JS005）
Injection
Experimental: Recombinant humanized IL-17A Monoclonal Antibody（JS005）300mg
Drug: Placebo（JS005）
Injection
Drug: Recombinant humanized IL-17A Monoclonal Antibody（JS005）
Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of SpondyloArthritis International Society criteria (ASAS）40
Time Frame: 16 weeks
Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 16.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of SpondyloArthritis International Society criteria (ASAS）40
Time Frame: 32 weeks
Proportion of subjects meeting Assessment of SpondyloArthritis International Society criteria (ASAS）40 response criteria at week 32.
32 weeks
Assessment of SpondyloArthritis International Society criteria (ASAS）20
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.
16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP)
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
16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) <2.1
Time Frame: 16 weeks and 32 weeks
Proportion of subjects with ASDAS-CRP less than 2.1 at weeks 16 and 32.
16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 1.1
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.
16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) ≥ 2.0
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.
16 weeks and 32 weeks
Ankylosing spondylitis disease activity score C-Reactive Protein (ASDAS-CRP) < 1.3
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
16 weeks and 32 weeks
Assessment of SpondyloArthritis International Society criteria (ASAS) partial remission
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
16 weeks and 32 weeks
Pharmacokinetic(PK)
Time Frame: 40 weeks
To evaluate the pharmacokinetic characteristics of JS005: blood concentration of JS005
40 weeks
Immunogenicity
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
40 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Collaborators

Sponsor GmbH

Investigators

  • Principal Investigator: Huji Xu, PhD, Shanghai Changzheng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Estimated)

February 26, 2025

Study Completion (Estimated)

October 8, 2025

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS005-006-Ⅱ-AS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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