Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis

  • STATUS
    Recruiting
  • days left to enroll
    88
  • participants needed
    105
  • sponsor
    Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Updated on 26 January 2021

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.

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 75mg Bid group, 100mg Bid group and a placebo control group. The subjects were randomly enrolled in the group 1:1:1.

Details
Condition Ankylosing spondylitis, Ankylosing spondylitis
Treatment Placebo, Jaktinib hydrochloride tablets
Clinical Study IdentifierNCT04507659
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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