<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/NCT04435392</url>
  </required_header>
  <id_info>
    <org_study_id>ZGJAKT002</org_study_id>
    <nct_id>NCT04435392</nct_id>
  </id_info>
  <brief_title>Jaktinib Hydrochloride Cream For Atopic Dermatitis</brief_title>
  <official_title>A Phase I/II Study Of The Efficacy,Safety and PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis</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 study includes a dose escalation part and a dose extension part.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind,&#xD;
      placebo-parallel control design was adopted. Subjects were enrolled into different dose&#xD;
      groups in sequence according to the inclusion sequence, and each group was scheduled to give&#xD;
      the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration.&#xD;
      When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects&#xD;
      in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next&#xD;
      set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream&#xD;
      (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be&#xD;
      enrolled in 6 centers.&#xD;
&#xD;
      The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control&#xD;
      design in which subjects were randomly assigned to 3 groups (1 placebo group and 2&#xD;
      experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in&#xD;
      about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) :&#xD;
      Extension test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 14, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
  <phase>Phase 1/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>Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear</measure>
    <time_frame>7 days after the last dose</time_frame>
    <description>A total PGA score of 0 or 1 or a decrease of ≥2 from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Response of Clear or Almost Clear From Baseline</measure>
    <time_frame>Treatment at 8,16 weeks</time_frame>
    <description>PGA score of 0 or 1</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">92</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Part 1: Cohort 1, 0.5% Jaktinib Bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Cohort 2,1.5% Jaktinib Bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Cohort 3, 2.5% Jaktinib Qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part 1: Cohort 4, 2.5% Jaktinib Bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose extension: Vehicle Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>the Vehicle Control cream will be applied topically twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose extension: low-dose group, X%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose extension: high-dose group, Y%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jaktinib Hydrochloride Cream</intervention_name>
    <description>Subjects in each group were scheduled to give the drug for 8 weeks.</description>
    <arm_group_label>Dose extension: high-dose group, Y%</arm_group_label>
    <arm_group_label>Dose extension: low-dose group, X%</arm_group_label>
    <arm_group_label>Part 1: Cohort 1, 0.5% Jaktinib Bid</arm_group_label>
    <arm_group_label>Part 1: Cohort 2,1.5% Jaktinib Bid</arm_group_label>
    <arm_group_label>Part 1: Cohort 3, 2.5% Jaktinib Qd</arm_group_label>
    <arm_group_label>Part 1: Cohort 4, 2.5% Jaktinib Bid</arm_group_label>
    <other_name>Jaktinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Dose extension: Vehicle Control</arm_group_label>
    <arm_group_label>Part 1: Cohort 1, 0.5% Jaktinib Bid</arm_group_label>
    <arm_group_label>Part 1: Cohort 2,1.5% Jaktinib Bid</arm_group_label>
    <arm_group_label>Part 1: Cohort 3, 2.5% Jaktinib Qd</arm_group_label>
    <arm_group_label>Part 1: Cohort 4, 2.5% Jaktinib Bid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18~ 65 years old (including boundary value), gender is not limited;&#xD;
&#xD;
          -  Have a clinical diagnosis of atopic dermatitis;&#xD;
&#xD;
          -  Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at&#xD;
             baseline;&#xD;
&#xD;
          -  The total area of atopic dermatitis is about 10%~20% of the total area of the body&#xD;
             surface at baseline.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of certain skin conditions/infections at baseline;&#xD;
&#xD;
          -  Have certain laboratory abnormalities at baseline;&#xD;
&#xD;
          -  Females who are pregnant, breastfeeding, or are of childbearing potential not using&#xD;
             highly effective contraception;&#xD;
&#xD;
          -  Other conditions that the investigators considered inappropriate to participate in the&#xD;
             trial.&#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>Qianjin Lu, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Central South University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atopic Dermatitis</keyword>
  <keyword>Jaktinib</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <!-- 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/NCT04435392
org study id: ZGJAKT002
nct id: NCT04435392
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study includes a dose escalation part and a dose extension part.
In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind,
      placebo-parallel control design was adopted. Subjects were enrolled into different dose
      groups in sequence according to the inclusion sequence, and each group was scheduled to give
      the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration.
      When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects
      in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next
      set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream
      (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be
      enrolled in 6 centers.

      The dose expansion was a multicenter, randomized, double-blind, placebo-parallel control
      design in which subjects were randomly assigned to 3 groups (1 placebo group and 2
      experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in
      about 15 centers. This part is divided into two stages.Stage 2 test (9 ~ 16 weeks) :
      Extension test.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear
time frame: 7 days after the last dose
description: A total PGA score of 0 or 1 or a decrease of ≥2 from baseline
measure: Proportion of Participants With Response of Clear or Almost Clear From Baseline
time frame: Treatment at 8,16 weeks
description: PGA score of 0 or 1
arm group label: Part 1: Cohort 1, 0.5% Jaktinib Bid
arm group type: Experimental
description: Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily.
arm group label: Part 1: Cohort 2,1.5% Jaktinib Bid
arm group type: Experimental
description: Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily.
arm group label: Part 1: Cohort 3, 2.5% Jaktinib Qd
arm group type: Experimental
description: Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily.
arm group label: Part 1: Cohort 4, 2.5% Jaktinib Bid
arm group type: Experimental
description: Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily.
arm group label: Dose extension: Vehicle Control
arm group type: Placebo Comparator
description: the Vehicle Control cream will be applied topically twice daily
arm group label: Dose extension: low-dose group, X%
arm group type: Experimental
description: X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily
arm group label: Dose extension: high-dose group, Y%
arm group type: Experimental
description: Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily
intervention type: Drug
intervention name: Jaktinib Hydrochloride Cream
description: Subjects in each group were scheduled to give the drug for 8 weeks.
arm group label: Dose extension: high-dose group, Y%
arm group label: Dose extension: low-dose group, X%
arm group label: Part 1: Cohort 1, 0.5% Jaktinib Bid
arm group label: Part 1: Cohort 2,1.5% Jaktinib Bid
arm group label: Part 1: Cohort 3, 2.5% Jaktinib Qd
arm group label: Part 1: Cohort 4, 2.5% Jaktinib Bid
other name: Jaktinib
intervention type: Drug
intervention name: Placebo
description: Placebo
arm group label: Dose extension: Vehicle Control
arm group label: Part 1: Cohort 1, 0.5% Jaktinib Bid
arm group label: Part 1: Cohort 2,1.5% Jaktinib Bid
arm group label: Part 1: Cohort 3, 2.5% Jaktinib Qd
arm group label: Part 1: Cohort 4, 2.5% Jaktinib Bid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Qianjin Lu, PhD
role: Principal Investigator
affiliation: Central South University
facility: 
country: China
responsible party type: Sponsor
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema