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

Last updated: February 6, 2022
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05242588
JS005-004-II-nr-axSpA
  • Ages 18-65
  • All Genders

Study Summary

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 .

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients who do not meet the modified New York criteria for AS in 1984; Meet the 2009axSpA classification criteria recommended by International Assessment Society of AxialSpondyloarthritis (ASAS): inflammatory back pain for at least 3 months; Age of onset < 45 years; Sacroiliitis on MRI with≥ 1 axial spondyloarthritis features or HLA-B27positive with ≥ 2 SpA features (MRI and X-ray of sacroiliac joint as confirmed bycentral readers).
  2. Objective signs of inflammation at screening: active inflammation of the sacroiliacjoints on MRI and/or high sensitivity C-reactive protein (hsCRP) > upper limit ofnormal without other diagnoses to explain the MRI results or elevated hsCRP.
  3. Active axSpA at screening and baseline: assessed by total Bath ankylosing spondylitisdisease 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 signinginformed consent. Female subjects of childbearing age are required to have a confirmednegative result of urine and/or serum pregnancy test performed within 3 days beforerandomization and agree to use reliable contraceptive measures during the study; Malesubjects and their female partners of childbearing age must agree to use reliablecontraception during the study.
  6. Patients meet at least one of the following: 1) have an inadequate or ineffectiveresponse to NSAIDs, 2) have been intolerant to at least one dose of NSAIDs, 3) havecontraindications to NSAIDs therapy. Inadequate or ineffective response to NSAIDs isdefined as no remission after continuous treatment with standard doses of at least 2NSAIDs 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 maintaina stable dose for at least 2 weeks prior to randomization.
  8. Patients using tumor necrosis factor α (TNFα) inhibitors must have experienced aninadequate response to the standard treatment dose for at least 3 months, or have beenintolerant to TNFα inhibitors.

Exclusion

Exclusion Criteria:

  1. Unable or unwilling to undergo MRI.
  2. Previous exposure to JS005 or any other biologic drug directly targeting IL-17 orIL-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 4weeks prior to randomization.
  5. Previous treatment with any biological immunomodulating agents other than the TNFαinhibitors.
  6. Treatment with JAK inhibitor agents within 8 weeks prior to randomization andunwilling to discontinue during the study.

Study Design

Total Participants: 120
Study Start date:
January 26, 2022
Estimated Completion Date:
June 10, 2023

Study 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.

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230001
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 410011
    China

    Site Not Available

  • Nanfang Hospital of Nanfang Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Sun Yat-sen Memorial Sun Yat-sen University

    Guangzhou, Guangdong 510120
    China

    Site Not Available

  • Shantou University Medical Collge No.1 Affiliated Hospital

    Shantou, Guangdong 515041
    China

    Site Not Available

  • Pking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518001
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 361001
    China

    Site Not Available

  • Tongji Hospital,Tongji Medical College of HUST

    Wuhan, Hubei 430030
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 361001
    China

    Site Not Available

  • The Affilated Hospital of Inner Mongdlia Medical University

    Hohhot, Inner Mongolia 100000
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116023
    China

    Site Not Available

  • Shengjing Hospital of China medical University

    Shenyang, Liaoning 110004
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 030001
    China

    Site Not Available

  • Shanghai Changzheng Hospital

    Shanghai, Shanghai 200003
    China

    Site Not Available

  • First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi 650032
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 600041
    China

    Site Not Available

  • North Sichuan Medical College Affiliated Hospital

    Nanchong, Sichuan 637000
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300041
    China

    Site Not Available

  • People's Hospital of Xinjiang Uygur Autonomous Region

    Urumqi, Xinjiang 8300001
    China

    Site Not Available

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 250063
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University,School of Medicine

    Hangzhou, Zhejiang 450052
    China

    Site Not Available

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