Status:
COMPLETED
Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis
Lead Sponsor:
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled design, and it is expected that about 105 cases will be enrolled in about 10 sites.
Detailed Description
The study is divided into two stages, the first stage (1-16 weeks) is the main study; the second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib Hydrochloride Tablets 75...
Eligibility Criteria
Inclusion
- Age 18-65, both gender;
- Active Ankylosing Spondylitis;
- Participants who have been treated with non-steroidal anti-inflammatory drugs(NSAIDs) and still have active disease, or Participants who are intolerant to NSAIDs and stop the drug;
- Participants receiving low-dose oral glucocorticoid therapy (≤10mg/d prednisone) should maintain a stable medication regimen for at least 4 weeks before the first dose of this study. Do not adjust the dose during the entire study period except in emergency situations.
- Participants receiving other non-prohibited co-drugs should maintain a stable medication regimen for at least 7 days before the first dose of this study;
- Understand and voluntarily signed informed consent.
Exclusion
- A history of known or suspected complete spinal rigidity, or clinical and imaging confirmed complete spinal rigidity;
- A history of any other autoimmune rheumatic disease;
- Any history of joint prosthesis infection, and the prosthesis is still in place;
- Participants who are using strong opioid analgesics (such as methadone, hydromorphone, morphine, etc.);
- Participants who have been treated with any JAK inhibitors (such as Tofacitinib, Baricitinib, Ruxolitinib, Filgotinib, Upadacitinib, etc.);
- Participants who have drug abuse or alcohol dependence;
- Participants who have had herpes virus infection in the past month;
- Participants who have a history of venous thrombosis (regardless of current treatment);
- Any significant clinical and laboratory abnormalities that the investigator believes will affect the safety evaluator；
- Participants who cannot be treated and followed up according to the trial protocol;
- Any Participant considered by the investigator to be unsuitable to participate in this clinical study
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2022
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT04507659
Start Date
December 1 2020
End Date
August 2 2022
Last Update
March 29 2023
Active Locations (1)
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1
Renji Hospital
Shanghai, Shanghai Municipality, China, 200011