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

Primary Purpose

Ankylosing Spondylitis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jaktinib
Placebo
Sponsored by
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants must be able to understand the study and signed the informed consent. 18-65 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. Exclusion Criteria: 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.

Sites / Locations

  • RenJi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jaktinib 100mg BID (twice daily)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.
ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 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 deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 2、4、8 and 12.
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.
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 2、4、8 and 12.
ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 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 deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])

Full Information

First Posted
May 6, 2023
Last Updated
July 24, 2023
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05861102
Brief Title
Efficacy and Safety Study of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)
Official Title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Jaktinib in Subjects With Active Ankylosing Spondylitis(AS)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2023 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
July 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
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of Jaktinib in subjects with active Ankylosing Spondylitis(AS).
Detailed Description
Approximately 258 eligible subjects (129 per arm) will be randomized in a 1:1 ratio to Jaktinib 100mg BID (twice daily) or matching placebo BID for a total of 16 weeks of blinded treatment. During the 16-week treatment period subjects will visit the clinic every two weeks until the Week 4 visit and then every 4 weeks until the completion of Week 16.

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
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jaktinib 100mg BID (twice daily)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Jaktinib
Intervention Description
Participants will receive 100 mg Jaktinib orally twice daily for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive matching placebo orally twice daily for 16 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 16
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.
Description
ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 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 deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])
Time Frame
Week 16
Title
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 40 response at Week 2、4、8 and 12.
Description
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.
Time Frame
Week 2、4、8 and 12
Title
Percentage of Participants with Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 2、4、8 and 12.
Description
ASAS20 is defined as a >= 20% improvement and an absolute improvement of >= 1 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 deterioration in the remaining domain (where deterioration is defined as a worsening of >= 20% and a net worsening of >= 1 unit [on a scale of 0 to 10])
Time Frame
Week 2、4、8 and 12

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: Participants must be able to understand the study and signed the informed consent. 18-65 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. Exclusion Criteria: 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.
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunde Bao
Phone
+86-0213284622
Email
baochunde_1678@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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