Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis (AS)

• ClinicalTrials.gov Identifier: NCT04507659
• Recruitment Status: Recruiting
• First Posted: August 11, 2020
• Last Update Posted: December 16, 2020
• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Information provided by (Responsible Party): Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Ankylosing Spondylitis	Drug: Jaktinib Hydrochloride Tablets; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional
• Estimated Enrollment: 105 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 1, 2020
• Estimated Primary Completion Date: December 2022
• Estimated Study Completion Date: December 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Jaktinib 100mg; 100 mg bid.po	Drug: Jaktinib Hydrochloride Tablets; Morning: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets; Evening: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets.
Active Comparator: Jaktinib 75mg; 75 mg bid.po	Drug: Jaktinib Hydrochloride Tablets; Morning: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets; Evening: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets.
Placebo Comparator: Placebo; Placebo bid.po	Drug: Placebo; Morning: 1*75mg simulated tablet, 2*50mg simulated tablets; Evening: 1*75mg simulated tablet, 2*50mg simulated tablets.

Outcome Measures

Primary Outcome Measures :

1. Assessment of Spondylo Arthritis International Society 20%（ASAS20） [ Time Frame: week 16 ]
   ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain.

Secondary Outcome Measures :

1. Mean change from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: week 2,4,8,12,16,20,24,32 ]
   It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.The score range was 0-10, the low score meant that the spinal movement was better.
2. Mean change from baseline in Bath ankylosing spondylitis functional index (BASFI) [ Time Frame: week 2,4,8,12,16,20,24,32 ]
   It assess functional status. It was evaluated with a 10-question questionnaire.The score range was 0-10, the low score meant that the spinal movement was better. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.
3. Mean change from baseline in Bath ankylosing spondylitis metrology index (BASMI) [ Time Frame: week 2,4,8,12,16,20,24,32 ]
   It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The score range was 0-10, the low score meant that the spinal movement was better.
4. Mean change from baseline in Ankylosing spondylitis quality of life（ASQoL） [ Time Frame: week 2,4,8,12,16,20,24,32 ]
   It evaluates quality of life. Each statement on the ASQoL (18-item) is given a score of "1" or "0". A score of "1" is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Contact: Baochun De, MD; 86-021-63284622; baochunde_1678@126.com

Locations

China, Shanghai

No.145 Shandong Zhong Lu; Recruiting

Shanghai, Shanghai, China, 200011

Sponsors and Collaborators

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Investigators

• Principal Investigator: Baochun De, MD; RenJi Hospital

More Information

• Responsible Party: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• ClinicalTrials.gov Identifier: NCT04507659
• Other Study ID Numbers: ZGJAK008
• First Posted: August 11, 2020
• Last Update Posted: December 16, 2020
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Suzhou Zelgen Biopharmaceuticals Co.,Ltd:

AS

Additional relevant MeSH terms:

Spondylitis; Spondylitis, Ankylosing; Bone Diseases, Infectious; Infection; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylarthropathies; Spondylarthritis; Ankylosis; Joint Diseases; Arthritis