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

An Open-Label, Multicenter, Extension Study to Assess the Long-Term 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.

Study Overview

• Status: Recruiting
• Conditions: Ankylosing Spondylitis
• Intervention / Treatment: Drug: Jaktinib

• Study Type: Interventional
• Enrollment (Estimated): 258
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Bin Xie; Phone Number: +86-0512-57018310; Email: xieb@zelgen.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200001
      • Recruiting
      • RenJi Hospital
      • Contact: Chunde Bao; Phone Number: +86-021-63284622; Email: baochunde_1678@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jaktinib 100mg BID (twice daily)	Drug: Jaktinib; Participants will receive 100 mg Jaktinib orally twice daily for 32 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ASAS20 Response at 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.	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	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.	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	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.	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	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.	Baseline, Week 4, 8, 12, 16，20，24，28 and 32

Collaborators and Investigators

• Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Chunde Bao, RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: May 6, 2023
• First Submitted That Met QC Criteria: May 6, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: ZGJAK030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No