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Completed

NCT Number: NCT05861128

Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)

The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The investigators concluded that the participants continued to benefit from treatment with Jaktinib.
  • The participants have been fully informed and voluntarily signed informed consent.
  • The participants completed the ZGJAK029 study for 16 weeks of treatment and visitation and had good compliance.
  • The interval between the participants' first dose and the last dose of ZGJAK029 ≤ 4 weeks.

Exclusion criteria

  • There were any grade ≥3 adverse events within 4 weeks prior to enrollment and no return to grade 1 or normal.
  • Within 4 weeks prior to enrollment, participants had the following infectious diseases: tuberculosis infection requiring treatment; HIV-positive, syphilis, HBV infection, HCV infection.
  • The investigators considered participants unsuitable for this study.

Treatment and study plan

Jaktinib

Drug

Participants will receive 100 mg Jaktinib orally twice daily for 32 weeks

Primary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Related Discontinuations at 32 Weeks

    Time frame: Baseline up to Week 32

    Treatment-emergent AEs were events that occurred between first dose of study drug and up to 32 weeks that were absent before treatment or that worsened relative to pretreatment state.

Secondary outcomes

  1. Percentage of Participants Achieving ASAS20 Response at Week 4, 8, 12, 16，20，24，28 and 32

    Time frame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32

    ASAS20 assess 4 domains: PGA of Disease (assess disease activity on a scale of 0 [not active] to 10 [very active], high score=more disease activity), total back pain (scale of 0 [no pain] to 10 [most severe pain], high score=more severity), Function (BASFI; participant's level of ability on scale of 0 [easy] to 10 [impossible], low score= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6-item questionnaire measure disease activity on a scale of 0 [none] to 10 [severe], high score=more disease activity). ASAS20 response: >= 20% improvement from baseline in disease activity and absolute change of >=1 unit in >=3 domains and no worsening of >=20% and an absolute change of >=1 unit in remaining domain.

  2. Percentage of Participants Achieving ASAS40 Response at Week 4, 8, 12, 16，20，24，28 and 32

    Time frame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32

    ASAS40 assessed 4 domains: the "PGA" (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), total back pain (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (from BASFI: assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (morning stiffness, Mean of Q5 and Q6 of BASDAI defined as 6 item questionnaire: measures disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity). ASAS40 response: >=40% and >=2 units improvement in >=3 domains and no worsening at all in the remaining domain.

  3. Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Week 4, 8, 12, 16，20，24，28 and 32

    Time frame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32

    Participants marked their level of total back pain on a numerical rating scale (NRS) ranged from 0 (no pain) to 10 (most severe pain), with higher scores indicated more severe pain.

  4. Percentage of Participants Achieving ASAS 5/6 Response at Week 4, 8, 12, 16，20，24，28 and 32

    Time frame: Baseline, Week 4, 8, 12, 16，20，24，28 and 32

    ASAS 5/6 consists of 6 domains: 4 used in ASAS20 - PGA (assess disease activity on a scale of 0 [not active] to 10 [very active], higher score=more disease activity), Spinal Pain (total back pain) (on a scale of 0 [no pain] to 10 [most severe pain], higher score=more severity), Function (using BASFI which assess participant's level of ability on a scale of 0 [easy] to 10 [impossible], lower scores= better functional health) and Inflammation (using BASDAI, mean of Q 5 and 6, which assess disease activity on a scale of 0 [none] to 10 [severe], higher score=more disease activity), CRP (was measured in mg per liter) and Spinal mobility was measured in centimeter and calculated as mean of right and left measurements of lateral spinal flexion from BASMI. ASAS 5/6: defined as >=20% improvement in at least 5 domains.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

An Open-Label, Multicenter, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 16, 2023
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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