Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis

NCT04507659 | Completed Phase 2

• 1 other identifier: ZGJAK008
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at 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.

  Week 16

Secondary Outcomes (4)

• 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 40 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 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 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32

  Week 2,4,8,12,16,20,24,32

Study Arms (3)

Jaktinib 100mg

EXPERIMENTAL

100 mg bid.po

Drug: Jaktinib Hydrochloride Tablets

Jaktinib 75mg

EXPERIMENTAL

75 mg bid.po

Drug: Jaktinib Hydrochloride Tablets

Placebo

PLACEBO COMPARATOR

Placebo bid.po

Drug: Placebo

Interventions

Jaktinib Hydrochloride Tablets DRUG

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

Also known as: Jaktinib

Jaktinib 75mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

Related Publications (1)

• 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.

  PMID: 39753296 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Chunde Bao, MD

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2020
• First Posted: August 11, 2020
• Study Start: December 1, 2020
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)