<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04507659</url>
  </required_header>
  <id_info>
    <org_study_id>ZGJAK008</org_study_id>
    <nct_id>NCT04507659</nct_id>
  </id_info>
  <brief_title>Jaktinib Hydrochloride Tablets In The Treatment of Active Ankylosing Spondylitis</brief_title>
  <acronym>AS</acronym>
  <official_title>A Multi-center, Randomized, Double-blind, Placebo, Parallel-controlled Phase Ⅱ Clinical Trial of Jaktinib Hydrochloride Tablets in the Treatment of Patients With Active Ankylosing Spondylitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suzhou Zelgen Biopharmaceuticals Co.,Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suzhou Zelgen Biopharmaceuticals Co.,Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled&#xD;
      design, and it is expected that about 105 cases will be enrolled in about 10 sites.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is divided into two stages, the first stage (1-16 weeks) is the main study; the&#xD;
      second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib&#xD;
      Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The&#xD;
      subjects were randomly enrolled in the group 1:1:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2020</start_date>
  <completion_date type="Actual">August 2, 2022</completion_date>
  <primary_completion_date type="Actual">August 2, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16</measure>
    <time_frame>Week 16</time_frame>
    <description>ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ASAS 20 at Week 2, 4, 8, 12, 20, 24, and 32</measure>
    <time_frame>Week 2,4,8,12,16,20,24,32</time_frame>
    <description>It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.The score range was 0-10, the low score meant that the spinal movement was better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ASAS 40 at Week 2, 4, 8, 12, 16, 20, 24, and 32</measure>
    <time_frame>Week 2,4,8,12,16,20,24,32</time_frame>
    <description>ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ASAS 70 at Week 2, 4, 8, 12, 16, 20, 24, and 32</measure>
    <time_frame>Week 2,4,8,12,16,20,24,32</time_frame>
    <description>It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The score range was 0-10, the low score meant that the spinal movement was better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32</measure>
    <time_frame>Week 2,4,8,12,16,20,24,32</time_frame>
    <description>ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Ankylosing Spondylitis</condition>
  <arm_group>
    <arm_group_label>Jaktinib 100mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 mg bid.po</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Jaktinib 75mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>75 mg bid.po</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo bid.po</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jaktinib Hydrochloride Tablets</intervention_name>
    <description>Morning: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets; Evening: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets.</description>
    <arm_group_label>Jaktinib 75mg</arm_group_label>
    <other_name>Jaktinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jaktinib Hydrochloride Tablets</intervention_name>
    <description>Morning: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets; Evening: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets.</description>
    <arm_group_label>Jaktinib 100mg</arm_group_label>
    <other_name>Jaktinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Morning: 1*75mg simulated tablet, 2*50mg simulated tablets; Evening: 1*75mg simulated tablet, 2*50mg simulated tablets.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-65, both gender;&#xD;
&#xD;
          -  Active Ankylosing Spondylitis;&#xD;
&#xD;
          -  Participants who have been treated with non-steroidal anti-inflammatory drugs(NSAIDs)&#xD;
             and still have active disease, or Participants who are intolerant to NSAIDs and stop&#xD;
             the drug;&#xD;
&#xD;
          -  Participants receiving low-dose oral glucocorticoid therapy (≤10mg/d prednisone)&#xD;
             should maintain a stable medication regimen for at least 4 weeks before the first dose&#xD;
             of this study. Do not adjust the dose during the entire study period except in&#xD;
             emergency situations.&#xD;
&#xD;
          -  Participants receiving other non-prohibited co-drugs should maintain a stable&#xD;
             medication regimen for at least 7 days before the first dose of this study;&#xD;
&#xD;
          -  Understand and voluntarily signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A history of known or suspected complete spinal rigidity, or clinical and imaging&#xD;
             confirmed complete spinal rigidity;&#xD;
&#xD;
          -  A history of any other autoimmune rheumatic disease;&#xD;
&#xD;
          -  Any history of joint prosthesis infection, and the prosthesis is still in place;&#xD;
&#xD;
          -  Participants who are using strong opioid analgesics (such as methadone, hydromorphone,&#xD;
             morphine, etc.);&#xD;
&#xD;
          -  Participants who have been treated with any JAK inhibitors (such as Tofacitinib,&#xD;
             Baricitinib, Ruxolitinib, Filgotinib, Upadacitinib, etc.);&#xD;
&#xD;
          -  Participants who have drug abuse or alcohol dependence;&#xD;
&#xD;
          -  Participants who have had herpes virus infection in the past month;&#xD;
&#xD;
          -  Participants who have a history of venous thrombosis (regardless of current&#xD;
             treatment);&#xD;
&#xD;
          -  Any significant clinical and laboratory abnormalities that the investigator believes&#xD;
             will affect the safety evaluator；&#xD;
&#xD;
          -  Participants who cannot be treated and followed up according to the trial protocol;&#xD;
&#xD;
          -  Any Participant considered by the investigator to be unsuitable to participate in this&#xD;
             clinical study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunde Bao, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>RenJi Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>March 23, 2023</last_update_submitted>
  <last_update_submitted_qc>March 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04507659
org study id: ZGJAK008
nct id: NCT04507659
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial uses a multi-center, randomized, double-blind, placebo, parallel-controlled
      design, and it is expected that about 105 cases will be enrolled in about 10 sites.
The study is divided into two stages, the first stage (1-16 weeks) is the main study; the
      second stage (17-32 weeks) is the extended study. This study set up 3 groups:Jaktinib
      Hydrochloride Tablets 75mg Bid group, 100mg Bid group and a placebo control group. The
      subjects were randomly enrolled in the group 1:1:1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Achieving 20 Percent (%) Improvement in Assessment of SpondyloArthritis International Society (ASAS) Score (ASAS 20) at Week 16
time frame: Week 16
description: ASAS20 responder had improvement of greater than or equal to (≥) 20% and ≥1 unit in at least 3 domains (on a scale of 0 [least] to 10 [worst]) and no worsening of ≥20% and less than or equal to (≤)1 unit in the remaining domain. The domains are: Patient's Global Assessment of Disease Activity, spinal pain, function and inflammation (from Bath Ankylosing Spondylitis Disease Activity Index [BASDAI]). Missing data were handled by nonresponsive (NRI)/ last observation carried forward (LOCF). Missing values due to a subject dropping out from the study were handled by setting the ASAS20 value to NRI. The LOCF approach was applied to missing components, if just some of the components of the ASAS20 were missing.
measure: Percentage of Participants Achieving ASAS 20 at Week 2, 4, 8, 12, 20, 24, and 32
time frame: Week 2,4,8,12,16,20,24,32
description: It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.The score range was 0-10, the low score meant that the spinal movement was better.
measure: Percentage of Participants Achieving ASAS 40 at Week 2, 4, 8, 12, 16, 20, 24, and 32
time frame: Week 2,4,8,12,16,20,24,32
description: ASAS 40 is defined as ≥40% and absolute change of ≥2 units in at least 3 domains on a 0-10 scale (0=no disease activity, 10=high disease activity), and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
measure: Percentage of Participants Achieving ASAS 70 at Week 2, 4, 8, 12, 16, 20, 24, and 32
time frame: Week 2,4,8,12,16,20,24,32
description: It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The score range was 0-10, the low score meant that the spinal movement was better.
measure: Percentage of Participants Achieving ASAS 5/6 Response at Weeks 2, 4, 8, 12, 16, 20, 24, and 32
time frame: Week 2,4,8,12,16,20,24,32
description: ASAS5/6 consists of 6 domains: the 4 used in ASAS20 (Patient's Global Assessment of Disease Activity, spinal pain, function, inflammation plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). ASAS 5/6 is defined as ≥20% improvement in at least 5 domains and no worsening in the remaining domain. Missing data were handled by NRI/LOCF.
arm group label: Jaktinib 100mg
arm group type: Experimental
description: 100 mg bid.po
arm group label: Jaktinib 75mg
arm group type: Experimental
description: 75 mg bid.po
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo bid.po
intervention type: Drug
intervention name: Jaktinib Hydrochloride Tablets
description: Morning: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets; Evening: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets.
arm group label: Jaktinib 75mg
other name: Jaktinib
intervention type: Drug
intervention name: Jaktinib Hydrochloride Tablets
description: Morning: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets; Evening: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets.
arm group label: Jaktinib 100mg
other name: Jaktinib
intervention type: Drug
intervention name: Placebo
description: Morning: 1*75mg simulated tablet, 2*50mg simulated tablets; Evening: 1*75mg simulated tablet, 2*50mg simulated tablets.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chunde Bao, MD
role: Principal Investigator
affiliation: RenJi Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Spondylitis, Ankylosing
sharing ipd: No