Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)

NCT05861102 | Active Not Recruiting Phase 3

• 1 other identifier: ZGJAK029
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 16

  ASAS40 is defined as a \>= 40% improvement and an absolute improvement of ≥ 2 units (on a scale of 0 to 10) from Baseline in at least 3 of the 4 domains (patient's global assessment, back pain, function and inflammation) with no worsening at all in the remaining domain.

  Week 16

Secondary Outcomes (3)

• Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.

  Week 16

• Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 2、4、8 and 12.

  Week 2、4、8 and 12

• Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 2、4、8 and 12.

  Week 2、4、8 and 12

Study Arms (2)

Jaktinib 100mg BID (twice daily)

EXPERIMENTAL

Drug: Jaktinib

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Jaktinib DRUG

Participants will receive 100 mg Jaktinib orally twice daily for 16 weeks

Jaktinib 100mg BID (twice daily)

Placebo DRUG

Participants will receive matching placebo orally twice daily for 16 weeks

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:

• Participants must be able to understand the study and signed the informed consent.
• years, male or female.
• Participants with a clinical diagnosis of ankylosing spondylitis (AS), and radiologic evidence (x-ray) fulfilling the Modified New York criteria for AS(1984).
• Participants must have baseline disease activity as defined by having a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and a Patient's Assessment of Total Back Pain score ≥ 4 based on a 0 - 10 Numeric Rating Scale (NRS) at the Screening and Baseline Visits.
• Participants may be receiving the following Disease-Modifying Anti-Rheumatic Drugs(DMARDs) at the time of the screening visit. These medications should be continued throughout the entire study and doses should remain unchanged.
• Participants has had an inadequate response to at least two Nonsteroidal Anti-inflammatory Drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or participant has an intolerance to or contraindication for NSAIDs.
• Participants who are regularly taking NSAIDs (including COX-1 or COX-2 inhibitors) as part of their AS therapy are required to be on a stable dose for at least 2 weeks before randomisation.
• Participants receiving non-prohibited concomitant medications for any reason must be willing to stay on a stable regimen as defined in the protocol.

You may not qualify if:

• History of known or suspected complete ankylosis of the spine.
• Any subject with condition affecting oral drug absorption.
• Participants taking high potency opioid analgesics (e.g. methadone, hydromorphone, morphine) within 4 weeks before randomization.
• Participants on any other DMARDs within 4 weeks or five half-lives (whichever is longer) of the drug prior to the Baseline visit.
• Participants has a history of inflammatory arthritis of different etiology other than axial SpA (including but not limited to rheumatoid arthritis, mixed connective tissue disease, systemic lupus erythematosus, reactive arthritis, scleroderma, polymyositis, dermatomyositis, fibromyalgia), or any arthritis with onset prior to 17 years of age.
• Significant trauma or surgery procedure within 8 weeks prior to randomization, or any planned elective surgery during the study period.
• Participants with a known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
• Participants with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery.
• Use of any investigational drug and/or devices within 4 weeks of randomization or a period of 5 half-lives of the investigational drug, whichever is longer.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

RenJi Hospital

Shanghai, Shanghai Municipality, 200001, China

Location

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

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 16, 2023
• Study Start: July 20, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

CN (1)