Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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).
- 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.
- 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).
- 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 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.
- 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.
- Patients regularly taking NSAIDs as part of their AS therapy are required to maintaina stable dose for at least 2 weeks prior to randomization.
- 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:
- Unable or unwilling to undergo MRI.
- Previous exposure to JS005 or any other biologic drug directly targeting IL-17 orIL-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 4weeks prior to randomization.
- Previous treatment with any biological immunomodulating agents other than the TNFαinhibitors.
- Treatment with JAK inhibitor agents within 8 weeks prior to randomization andunwilling to discontinue during the study.
Study Design
Study Description
Connect with a study center
Anhui Provincial Hospital
Hefei, Anhui 230001
ChinaSite Not Available
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 410011
ChinaSite Not Available
Nanfang Hospital of Nanfang Medical University
Guangzhou, Guangdong 510515
ChinaActive - Recruiting
Sun Yat-sen Memorial Sun Yat-sen University
Guangzhou, Guangdong 510120
ChinaSite Not Available
Shantou University Medical Collge No.1 Affiliated Hospital
Shantou, Guangdong 515041
ChinaSite Not Available
Pking University Shenzhen Hospital
Shenzhen, Guangdong 518036
ChinaSite Not Available
Shenzhen People's Hospital
Shenzhen, Guangdong 518001
ChinaSite Not Available
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 361001
ChinaSite Not Available
Tongji Hospital,Tongji Medical College of HUST
Wuhan, Hubei 430030
ChinaSite Not Available
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410013
ChinaSite Not Available
The Third Xiangya Hospital of Central South University
Changsha, Hunan 361001
ChinaSite Not Available
The Affilated Hospital of Inner Mongdlia Medical University
Hohhot, Inner Mongolia 100000
ChinaSite Not Available
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaSite Not Available
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning 116023
ChinaSite Not Available
Shengjing Hospital of China medical University
Shenyang, Liaoning 110004
ChinaSite Not Available
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning 110001
ChinaSite Not Available
Qilu Hospital of Shandong University
Jinan, Shandong 030001
ChinaSite Not Available
Shanghai Changzheng Hospital
Shanghai, Shanghai 200003
ChinaSite Not Available
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi 650032
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, Sichuan 600041
ChinaSite Not Available
North Sichuan Medical College Affiliated Hospital
Nanchong, Sichuan 637000
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, Tianjin 300041
ChinaSite Not Available
People's Hospital of Xinjiang Uygur Autonomous Region
Urumqi, Xinjiang 8300001
ChinaSite Not Available
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan 250063
ChinaSite Not Available
The Second Affiliated Hospital of Zhejiang University,School of Medicine
Hangzhou, Zhejiang 450052
ChinaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.