Clinical trial NCT04507659: Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Lead sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2020-08-11
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;
* Any Participant considered by the investigator to be unsuitable to participate in this clinical study

Primary outcomes:
measure: Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving ASAS 20 at Week 2, 4, 8, 12, 20, 24, and 32
timeFrame: Week 2,4,8,12,16,20,24,32
measure: Percentage of Participants Achieving ASAS 40 at Week 2, 4, 8, 12, 16, 20, 24, and 32
timeFrame: Week 2,4,8,12,16,20,24,32
measure: Percentage of Participants Achieving ASAS 70 at Week 2, 4, 8, 12, 16, 20, 24, and 32
timeFrame: Week 2,4,8,12,16,20,24,32
measure: Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32
timeFrame: Week 2,4,8,12,16,20,24,32
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Chunde Bao, MD
role: PRINCIPAL_INVESTIGATOR
References: