Back to resultsExtension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
Primary Purpose
Ankylosing Spondylitis
Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jaktinib
Sponsored by
About this trial
This is an interventional treatment trial for Ankylosing Spondylitis
Eligibility Criteria
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.
Sites / Locations
- Renji Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Jaktinib 100mg BID (twice daily)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT05861128
First Posted
May 6, 2023
Last Updated
July 10, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05861128
Brief Title
Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
Official Title
An Open-Label, Multicenter, Extension Study to Assess the Long-Term Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2024 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if Jaktinib is safe and effective in participants with active ankylosing spondylitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
258 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Jaktinib 100mg BID (twice daily)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
Participants will receive 100 mg Jaktinib orally twice daily for 32 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Related Discontinuations at 32 Weeks
Description
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.
Time Frame
Baseline up to Week 32
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving ASAS20 Response at Week 4, 8, 12, 16，20，24，28 and 32
Description
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.
Time Frame
Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Title
Percentage of Participants Achieving ASAS40 Response at Week 4, 8, 12, 16，20，24，28 and 32
Description
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.
Time Frame
Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Title
Change From Baseline in Patient's Assessment of Spinal Pain: Total Back Pain at Week 4, 8, 12, 16，20，24，28 and 32
Description
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.
Time Frame
Baseline, Week 4, 8, 12, 16，20，24，28 and 32
Title
Percentage of Participants Achieving ASAS 5/6 Response at Week 4, 8, 12, 16，20，24，28 and 32
Description
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.
Time Frame
Baseline, Week 4, 8, 12, 16，20，24，28 and 32
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Xie
Phone
+86-0512-57018310
Email
xieb@zelgen.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunde Bao
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Renji Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunde Bao
Phone
+86-021-63284622
Email
baochunde_1678@126.com
12. IPD Sharing Statement
Learn more about this trial
Extension Study to Evaluate Safety and Efficacy of Jaktinib in Patients With Active Ankylosing Spondylitis(AS)
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