Evaluate the Preliminary Efficacy, Safety, and PK of Subcutaneous JS005 in Chinese Adult Patients With Active Nr-axSpA
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
1 other identifier
interventional
120
1 country
25
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2022
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2021
CompletedStudy Start
First participant enrolled
January 26, 2022
CompletedFirst Posted
Study publicly available on registry
February 16, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2023
CompletedFebruary 16, 2022
February 1, 2022
1.2 years
November 30, 2021
February 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of nr-axSpA patients meeting the Assessment of Spondylo Arthritis international Society (ASAS) 40 response criteria
at the end of treatment Week 16 .
From week 0 to week 16
Secondary Outcomes (12)
ASAS20 response criteria
From week 0 to week 16
ASAS 5/6 response criteria
From week 0 to week 16
High-sensitivity C-reactive protein (hsCRP)
From week 0 to week 16
The inflammation score of the sacroiliac joint
From week 0 to week 16
Ankylosing Spondylitis Disease Activity Score (ASDAS-CRP)
From week 0 to week 16
- +7 more secondary outcomes
Other Outcomes (4)
Pharmacokinetic endpoint
From Baseline to week 24,Total 24 weeks
Pharmacodynamic endpoint
From Baseline to week 24,Total 24 weeks
Immunogenicity endpoint
From Baseline to week 24,Total 24 weeks
- +1 more other outcomes
Study Arms (6)
JS005 150 mg
EXPERIMENTAL30 patients will be enrolled in this arm.
Placebo 150 mg
PLACEBO COMPARATOR10 patients will be enrolled in this arm.
JS005 300 mg
EXPERIMENTAL30 patients will be enrolled in this arm.
Placebo 300 mg
PLACEBO COMPARATOR10 patients will be enrolled in this arm.
JS005 450 mg
EXPERIMENTAL30 patients will be enrolled in this arm.
Placebo 450
PLACEBO COMPARATOR10 patients will be enrolled in this arm.
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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).
- 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.
- 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).
- Voluntarily participate in this clinical trial and sign the informed consent form.
- 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.
- 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.
- 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.
- 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.
You may not qualify if:
- Unable or unwilling to undergo MRI.
- Previous exposure to JS005 or any other biologic drug directly targeting IL-17 or IL-17 receptor.
- Have taken high potency analgesics (e.g., opiates of methadone, hydromorphone, morphine) within 2 weeks prior to randomization.
- Previous treatment with any intra-articular injection (e.g., glucocorticoids) within 4 weeks prior to randomization.
- Previous treatment with any biological immunomodulating agents other than the TNFα inhibitors.
- Treatment with JAK inhibitor agents within 8 weeks prior to randomization and unwilling to discontinue during the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shanghai Junshi Bioscience Co., Ltd.lead
- Sponsor GmbHcollaborator
Study Sites (25)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 410011, China
Sun Yat-sen Memorial Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
Nanfang Hospital of Nanfang Medical University
Guangzhou, Guangdong, 510515, China
Shantou University Medical Collge No.1 Affiliated Hospital
Shantou, Guangdong, 515041, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518001, China
Pking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 361001, China
Tongji Hospital,Tongji Medical College of HUST
Wuhan, Hubei, 430030, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 361001, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The Affilated Hospital of Inner Mongdlia Medical University
Hohhot, Inner Mongolia, 100000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116023, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shengjing Hospital of China medical University
Shenyang, Liaoning, 110004, China
Qilu Hospital of Shandong University
Jinan, Shandong, 030001, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003, China
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 650032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 600041, China
North Sichuan Medical College Affiliated Hospital
Nanchong, Sichuan, 637000, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300041, China
People's Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 8300001, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 250063, China
The Second Affiliated Hospital of Zhejiang University,School of Medicine
Hangzhou, Zhejiang, 450052, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Priticipant,Care provider and investigators are masked in this study
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2021
First Posted
February 16, 2022
Study Start
January 26, 2022
Primary Completion
April 1, 2023
Study Completion
June 10, 2023
Last Updated
February 16, 2022
Record last verified: 2022-02