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

NCT05861128 | Unknown Phase 3

• 1 other identifier: ZGJAK030
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline up to Week 32

Secondary Outcomes (4)

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

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

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

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

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

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

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

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

Study Arms (1)

Jaktinib 100mg BID (twice daily)

EXPERIMENTAL

Drug: Jaktinib

Interventions

Jaktinib DRUG

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

Jaktinib 100mg BID (twice daily)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

Renji Hospital

Shanghai, Shanghai Municipality, 200001, China

RECRUITING

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

Central Study Contacts

Bin Xie

CONTACT

+86-0512-57018310; xieb@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 16, 2023
• Study Start: November 10, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

CN (1)