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

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Subjects voluntarily particpate in this clinical study and sign the informed consent form.

• Male and female patients aged 18-75 years at the time of screening (both inclusive)

• 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)

Locations
Other Locations
China
The First Affiliated Hospital of Baotou Medical University
NOT_YET_RECRUITING
Baotou
Beijing Chao-yang Hospital,Capital Medical University
NOT_YET_RECRUITING
Beijing
Binzhou Medical University Hospital
NOT_YET_RECRUITING
Binzhou
Bethune First Hospital Of Jilin University
NOT_YET_RECRUITING
Changchun
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Dongguan People's Hospital
NOT_YET_RECRUITING
Dongguan
First Affiliated Hospital of Gannan Medical University
NOT_YET_RECRUITING
Ganzhou
Guangdong Provincial People's Hospital
NOT_YET_RECRUITING
Guangzhou
Sun Yat-sen Memorial Hospital
NOT_YET_RECRUITING
Guangzhou
The Third Affiliated Hospital of Sun Yat-sen University
NOT_YET_RECRUITING
Guangzhou
Zhujiang Hospital of Southren Medical University
NOT_YET_RECRUITING
Guangzhou
The Affiliated Hospital of Inner Mongolia Medical University
NOT_YET_RECRUITING
Hohhot
Huizhou Central People's Hospital
NOT_YET_RECRUITING
Huizhou
Jieyang People's Hospital
RECRUITING
Jieyang
Jilin Province People's Hospital
NOT_YET_RECRUITING
Jilin
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
The First People's Hospital of Jiujiang City
NOT_YET_RECRUITING
Jiujiang
Gansu Provincial Hospital
NOT_YET_RECRUITING
Lanzhou
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
The Second Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
Nanyang Central Hospital
RECRUITING
Nanyang
Pingxiang People's Hospital
NOT_YET_RECRUITING
Pingxiang
Shanghai Changzheng Hospital
NOT_YET_RECRUITING
Shanghai
The First Affiliated Hospital of Shantou University Medical College
NOT_YET_RECRUITING
Shantou
The First Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Shenzhen People's Hospital
NOT_YET_RECRUITING
Shenzhen
Shenzhen Second People's Hospital
NOT_YET_RECRUITING
Shenzhen
Second Hospital of Shanxi Medical University
NOT_YET_RECRUITING
Taiyuan
Xinjiang Uygur Autonomous Region People's Hospital
NOT_YET_RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xiamen University
NOT_YET_RECRUITING
Xiamen
Zhongshan Hospital Xiamen University
NOT_YET_RECRUITING
Xiamen
Xuzhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
Zaozhuang Municipal Hospital
NOT_YET_RECRUITING
Zaozhuang
Zhengzhou Central Hospital
NOT_YET_RECRUITING
Zhengzhou
Zhuzhou Central Hospital
NOT_YET_RECRUITING
Zhuzhou
Contact Information
Primary
Jiexin Hu
jiexin_hu@junshipharma.com
13521183167
Time Frame
Start Date: 2024-01-12
Estimated Completion Date: 2025-10-08
Participants
Target number of participants: 261
Treatments
Experimental: Placebo(JS005)
Experimental: Recombinant humanized IL-17A Monoclonal Antibody(JS005)150mg
Experimental: Recombinant humanized IL-17A Monoclonal Antibody(JS005)300mg
Related Therapeutic Areas
Sponsors
Leads: Shanghai Junshi Bioscience Co., Ltd.
Collaborators: Sponsor GmbH

This content was sourced from clinicaltrials.gov