A Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase Ⅱ Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing Spondylitis
Overview
- Phase
- Phase 2
- Intervention
- Jaktinib Hydrochloride Tablets
- Conditions
- Ankylosing Spondylitis
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 75mg Bid group, 100mg Bid group and a placebo control group. The subjects were randomly enrolled in the group 1:1:1.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 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;
- •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;
Arms & Interventions
Jaktinib 100mg
100 mg bid.po
Intervention: Jaktinib Hydrochloride Tablets
Jaktinib 75mg
75 mg bid.po
Intervention: Jaktinib Hydrochloride Tablets
Placebo
Placebo bid.po
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
Time Frame: Week 16
ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 \[least\] to 10 \[worst\]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
Secondary Outcomes
- Percentage of Participants Achieving ASAS 20 at Week 2, 4, 8, 12, 20, 24, and 32(Week 2,4,8,12,16,20,24,32)
- Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32(Week 2,4,8,12,16,20,24,32)
- Percentage of Participants Achieving ASAS 70 at Week 2, 4, 8, 12, 16, 20, 24, and 32(Week 2,4,8,12,16,20,24,32)
- Percentage of Participants Achieving ASAS 40 at Week 2, 4, 8, 12, 16, 20, 24, and 32(Week 2,4,8,12,16,20,24,32)