Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Criteria

Inclusion Criteria:

• Age 18-65, both gender;

• Active Ankylosing Spondylitis;

• Patients who have been treated with non-steroidal anti-inflammatory drugs(NSAIDs) and still have active disease, or patients who are intolerant to NSAIDs and stop the drug;

• Subjects 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.

• Subjects 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 Criteria:

• 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;

• Those who are using strong opioid analgesics (such as methadone, hydromorphone, morphine, etc.);

• Patients who have been treated with any JAK inhibitors (such as tofacitinib, baritinib, rocotinib, figatinib, upatinib, etc.);

• People who have drug abuse or alcohol dependence;

• People who have had herpes virus infection in the past month;

• People 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；

• People who cannot be treated and followed up according to the trial protocol;

• Any subject considered by the investigator to be unsuitable to participate in this clinical study