Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis

NCT ID: NCT04507659

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2022-08-02

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.

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Jaktinib 100mg

100 mg bid.po

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

Morning: 1\*75mg simulated tablet, 2\*50mg Jaktinib Hydrochloride Tablets; Evening: 1\*75mg simulated tablet, 2\*50mg Jaktinib Hydrochloride Tablets.

Jaktinib 75mg

75 mg bid.po

Group Type: EXPERIMENTAL

Jaktinib Hydrochloride Tablets

Intervention Type: DRUG

Morning: 2\*50mg simulated tablets and 1\*75mg Jaktinib Hydrochloride Tablets; Evening: 2\*50mg simulated tablets and 1\*75mg Jaktinib Hydrochloride Tablets.

Placebo

Placebo bid.po

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Morning: 1\*75mg simulated tablet, 2\*50mg simulated tablets; Evening: 1\*75mg simulated tablet, 2\*50mg simulated tablets.

Interventions

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.

Intervention Type: DRUG

Jaktinib Hydrochloride Tablets

Morning: 1\*75mg simulated tablet, 2\*50mg Jaktinib Hydrochloride Tablets; Evening: 1\*75mg simulated tablet, 2\*50mg Jaktinib Hydrochloride Tablets.

Intervention Type: DRUG

Placebo

Morning: 1\*75mg simulated tablet, 2\*50mg simulated tablets; Evening: 1\*75mg simulated tablet, 2\*50mg simulated tablets.

Intervention Type: DRUG

Other Intervention Names

Jaktinib; Jaktinib

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chunde Bao, MD

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Locations

Renji Hospital

Shanghai, Shanghai Municipality, China

Countries

China

References

Wang J, Bao C, Dai Q, Xu A, Ye Y. Efficacy and safety of jaktinib hydrochloride tablets in active axial spondyloarthritis: a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial. RMD Open. 2025 Jan 2;11(1):e004865. doi: 10.1136/rmdopen-2024-004865.

Reference Type: DERIVED

PMID: 39753296 (View on PubMed)

Other Identifiers

ZGJAK008

Identifier Type: -

Identifier Source: org_study_id