Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA

February 6, 2022 updated by: Shanghai Junshi Bioscience Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Phase II, Multicenter Study to Evaluate the Preliminary Efficacy, Safety, and Pharmacokinetics of Subcutaneous JS005 in Chinese Adults With Active Non-radiographic Axial Spondyloarthritis

The purpose of this study is to evaluate preliminary efficacy, safety pharmacokinetic (PK) characteristics, pharmacodynamics (PD) haracteristics and immunogenicity of JS005 at different doses in Chinese patients with active non-radiographic axial spondyloarthritis(nr-axSpA). Treatment difference of JS005 150mg,300mg,450mg vs. placebo in Chinese nr-axSpA patients in terms of ASAS 40 response rate at Week 16 as well as safety profile will be provided by the study .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled study. Approximately 120 patients who meet the eligibility criteria will be randomized to one of three treatment cohorts (JS005 150 mg, 300 mg, 450mg in a ratio of 1:1:1),then using secondary randomization method, 40 patients in each group will be randomized in a 3: 1 ratio to receive investigational product or placebo.

  1. JS005 150mg Cohort: JS005 150 mg or placebo treatment(JS005:Placrbo=3:1) s.c. prefilled syringe (PFS) on Week 0, 1, 2, 3, 4,8 and 12
  2. JS005 300mg Cohort: JS005 300 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 3 .JS005 450mg Cohort: JS005 450 mg or placebo treatment(JS005:Placrbo=3:1) s.c. PFS on Week0, 1, 2 ,3, 4,8,and 12 Based on the clinical judgment of disease activity by the investigator and the patient, background medications, such as NSAIDs and DMARDs, may have been modified or added to treat signs and symptoms of nr-axSpA from Week 16 on.

Study Type

Interventional

Enrollment (Anticipated)

120

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 Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Xiaomei Li, M.D.
    • Fujian
      • Xiamen, Fujian, China, 410011
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
        • Principal Investigator:
          • Guixiu Shi, M.D.
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Nanfang Medical University
        • Contact:
        • Principal Investigator:
          • Min Yang, M.D.
      • Guangzhou, Guangdong, China, 510120
        • Not yet recruiting
        • Sun Yat-sen Memorial Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Donghui Zhen, M.D.
      • Shantou, Guangdong, China, 515041
        • Not yet recruiting
        • Shantou University Medical Collge No.1 Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Zhiyi Hou, M.D.
      • Shenzhen, Guangdong, China, 518001
        • Not yet recruiting
        • ShenZhen People's Hospital
        • Principal Investigator:
          • Dongzhou LIU, M.D.
        • Contact:
      • Shenzhen, Guangdong, China, 518036
        • Not yet recruiting
        • Pking University Shenzhen Hospital
        • Contact:
        • Principal Investigator:
          • Qingwen Wang, M.D.
    • Henan
      • Zhengzhou, Henan, China, 361001
        • Not yet recruiting
        • the First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Principal Investigator:
          • Shengyun Liu, M.D.
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Not yet recruiting
        • Tongji Hospital,Tongji Medical college of Hust
        • Contact:
        • Principal Investigator:
          • Linli Dong, M.D.
    • Hunan
      • Changsha, Hunan, China, 361001
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
        • Principal Investigator:
          • Jian Sun, M.D.
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
        • Principal Investigator:
          • Xi Xie, M.D.
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China, 100000
        • Not yet recruiting
        • The Affilated Hospital of Inner Mongdlia Medical University
        • Principal Investigator:
          • Hongbin LI, M.D.
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Not yet recruiting
        • The First Hospital of Jilin University
        • Contact:
        • Principal Investigator:
          • Zhenyu Jia, M.D.
    • Liaoning
      • Dalian, Liaoning, China, 116023
        • Not yet recruiting
        • The Second Affiliated Hospital of Dalian Medical University
        • Principal Investigator:
          • Xiaodan Kong, M.D.
        • Contact:
      • Shenyang, Liaoning, China, 110004
        • Not yet recruiting
        • Shengjing Hospital Of China Medical University
        • Contact:
        • Principal Investigator:
          • Xiaofei Wang, M.D.
      • Shenyang, Liaoning, China, 110001
        • Not yet recruiting
        • The First Affiliated Hospital of China Medical University
        • Contact:
        • Principal Investigator:
          • Pinting Yang, M.D.
    • Shandong
      • Jinan, Shandong, China, 030001
        • Not yet recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Huaxiang Liu, M.D.
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Not yet recruiting
        • Shanghai Changzheng Hospital
        • Contact:
        • Principal Investigator:
          • Huji Xu, M.D.
    • Shanxi
      • Taiyuan, Shanxi, China, 650032
        • Not yet recruiting
        • First Affiliated Hospital of Shanxi Medical University
        • Contact:
        • Principal Investigator:
          • Zili Fu, M.D.
    • Sichuan
      • Chengdu, Sichuan, China, 600041
        • Not yet recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Principal Investigator:
          • Yi liu, M.D.
      • Nanchong, Sichuan, China, 637000
        • Not yet recruiting
        • North Sichuan Medical College Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Guohua Yuan, M.D.
    • Tianjin
      • Tianjin, Tianjin, China, 300041
        • Not yet recruiting
        • Tianjin Medical University General Hospital
        • Principal Investigator:
          • Wei Wei, M.D.
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 8300001
        • Not yet recruiting
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • Contact:
        • Principal Investigator:
          • Lijun Wu, M.D.
    • Yunnan
      • Kunming, Yunnan, China, 250063
        • Not yet recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Jian Xu, M.D.
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 450052
        • Not yet recruiting
        • The Second Affiliated Hospital of Zhejiang University,School of Medicine
        • Contact:
        • Principal Investigator:
          • Huaxiang Wu, M.D.

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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who do not meet the modified New York criteria for AS in 1984; Meet the 2009 axSpA classification criteria recommended by International Assessment Society of Axial Spondyloarthritis (ASAS): inflammatory back pain for at least 3 months; Age of onset < 45 years; Sacroiliitis on MRI with≥ 1 axial spondyloarthritis features or HLA-B27 positive with ≥ 2 SpA features (MRI and X-ray of sacroiliac joint as confirmed by central readers).
  2. Objective signs of inflammation at screening: active inflammation of the sacroiliac joints on MRI and/or high sensitivity C-reactive protein (hsCRP) > upper limit of normal without other diagnoses to explain the MRI results or elevated hsCRP.
  3. Active axSpA at screening and baseline: assessed by total Bath ankylosing spondylitis disease activity index (BASDAI) ≥ 4 (0-10 scale) and spinal pain ≥ 4 (according to the 0-10 NRS scale, BASDAI question #2).
  4. Voluntarily participate in this clinical trial and sign the informed consent form.
  5. Male or female aged between 18 and 65 years (both inclusive) at the time of signing informed consent. Female subjects of childbearing age are required to have a confirmed negative result of urine and/or serum pregnancy test performed within 3 days before randomization and agree to use reliable contraceptive measures during the study; Male subjects and their female partners of childbearing age must agree to use reliable contraception during the study.
  6. Patients meet at least one of the following: 1) have an inadequate or ineffective response to NSAIDs, 2) have been intolerant to at least one dose of NSAIDs, 3) have contraindications to NSAIDs therapy. Inadequate or ineffective response to NSAIDs is defined as no remission after continuous treatment with standard doses of at least 2 NSAIDs for a total of no less than 4 weeks and no less than 2 weeks for each NSAID.
  7. Patients regularly taking NSAIDs as part of their AS therapy are required to maintain a stable dose for at least 2 weeks prior to randomization.
  8. Patients using tumor necrosis factor α (TNFα) inhibitors must have experienced an inadequate response to the standard treatment dose for at least 3 months, or have been intolerant to TNFα inhibitors.

Exclusion Criteria:

  1. Unable or unwilling to undergo MRI.
  2. Previous exposure to JS005 or any other biologic drug directly targeting IL-17 or IL-17 receptor.
  3. Have taken high potency analgesics (e.g., opiates of methadone, hydromorphone, morphine) within 2 weeks prior to randomization.
  4. Previous treatment with any intra-articular injection (e.g., glucocorticoids) within 4 weeks prior to randomization.
  5. Previous treatment with any biological immunomodulating agents other than the TNFα inhibitors.
  6. Treatment with JAK inhibitor agents within 8 weeks prior to randomization and unwilling to discontinue during the study.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JS005 150 mg
30 patients will be enrolled in this arm.
Biological: JS005
30 subjectes in JS005 150mg chort, JS005 300mg chort, and JS005 450mg chort receive JS005 150mg, JS005 300mg and JS005 450mg subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
Other Names:
  • Recombinant humanized anti-IL-17A monoclonal antibody injection
Placebo Comparator: Placebo 150 mg
10 patients will be enrolled in this arm.
Biological: Placebo
10 subjects in JS005 150mg chort, JS005 300mg chort, and JS005 450mgchort receive the placebo subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
Experimental: JS005 300 mg
30 patients will be enrolled in this arm.
Biological: JS005
30 subjectes in JS005 150mg chort, JS005 300mg chort, and JS005 450mg chort receive JS005 150mg, JS005 300mg and JS005 450mg subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
Other Names:
  • Recombinant humanized anti-IL-17A monoclonal antibody injection
Placebo Comparator: Placebo 300 mg
10 patients will be enrolled in this arm.
Biological: Placebo
10 subjects in JS005 150mg chort, JS005 300mg chort, and JS005 450mgchort receive the placebo subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
Experimental: JS005 450 mg
30 patients will be enrolled in this arm.
Biological: JS005
30 subjectes in JS005 150mg chort, JS005 300mg chort, and JS005 450mg chort receive JS005 150mg, JS005 300mg and JS005 450mg subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).
Other Names:
  • Recombinant humanized anti-IL-17A monoclonal antibody injection
Placebo Comparator: Placebo 450
10 patients will be enrolled in this arm.
Biological: Placebo
10 subjects in JS005 150mg chort, JS005 300mg chort, and JS005 450mgchort receive the placebo subcutaneous injection seperately at Week 0, 1, 2, and 3, and monthly dose starting at Week 4 (dosing in Week 4, 8, and 12).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of nr-axSpA patients meeting the Assessment of Spondylo Arthritis international Society (ASAS) 40 response criteria
Time Frame: From week 0 to week 16
at the end of treatment Week 16 .
From week 0 to week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASAS20 response criteria
Time Frame: From week 0 to week 16
The proportion of patients meeting the ASAS20 response criteria at the end of treatment Week 16
From week 0 to week 16
ASAS 5/6 response criteria
Time Frame: From week 0 to week 16
The proportion of patients meeting the ASAS 5/6 response criteria at the end of treatment Week 16;
From week 0 to week 16
High-sensitivity C-reactive protein (hsCRP)
Time Frame: From week 0 to week 16
The change from baseline in high-sensitivity C-reactive protein (hsCRP) at the end of treatment Week 16
From week 0 to week 16
The inflammation score of the sacroiliac joint
Time Frame: From week 0 to week 16
The change from baseline in the inflammation score of the sacroiliac joint by MRI at the end of treatment Week 16
From week 0 to week 16
Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
Time Frame: From week 0 to week 16
The change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP) at the end of treatment Week 16;
From week 0 to week 16
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: From week 0 to week 16
The change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the end of treatment Week 16
From week 0 to week 16
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: From week 0 to week 16
The change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at the end of treatment Week 16
From week 0 to week 16
Bath Ankylosing Spondylitis Disease Metrology Index (BASMI)
Time Frame: From week 0 to week 16
The change from baseline in Bath Ankylosing Spondylitis Disease Metrology Index (BASMI) at the end of treatment Week 16
From week 0 to week 16
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)
Time Frame: From week 0 to week 16
The change from baseline in Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL) at the end of treatment Week 16
From week 0 to week 16
The patient's global assessment of disease activity
Time Frame: From week 0 to week 16
Numeric Rating Scale (NRS, ranging from 0 not active to 10 very active) will be used to evaluate the patient's global assessment of disease activity. Patient will be asked by one question: How active was your spondylitis on average during the last week？
From week 0 to week 16
The patient's assessment of inflammatory back pain intensity
Time Frame: From week 0 to week 16
NRS(ranging from 0 no pain to 10 most severe pain) will be used to assess the patient's inflammatory back pain intensity. The assessment is based on two questions: "Based on your assessment, please indicate How much pain of your spine due to AS do you have ?" and "Based on your assessment, please specify How much pain of your spine due to AS do you have at night?" When responding, the subject is to consider the average amount of pain in the last week.
From week 0 to week 16
ASAS partial remission criteria
Time Frame: From week 0 to week 16
The proportion of patients meeting ASAS partial remission criteria at the end of treatment Week 16
From week 0 to week 16

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic endpoint
Time Frame: From Baseline to week 24,Total 24 weeks
• Population pharmacokinetic analysis of plasma concentrations will be performed to explore the exposure of JS005 in patients and the influencing factors of exposure
From Baseline to week 24,Total 24 weeks
Pharmacodynamic endpoint
Time Frame: From Baseline to week 24,Total 24 weeks
• Concentrations and the changes of free and/or total IL-17 in serum before and after administration.
From Baseline to week 24,Total 24 weeks
Immunogenicity endpoint
Time Frame: From Baseline to week 24,Total 24 weeks
• Anti-drug antibody (ADA), for the ADA positive samples, it is necessary to test the titer and determine whether it is a neutralizing antibody (Nab).
From Baseline to week 24,Total 24 weeks
Safety evaluation
Time Frame: From V1 to V12, Total 36 Weeks
Safety evaluation will be documented as numbers of adverse event(AE).
From V1 to V12, Total 36 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

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 26, 2022

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

June 10, 2023

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

February 6, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 6, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS005-004-II-nr-axSpA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided

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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