<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/NCT04445363</url>
  </required_header>
  <id_info>
    <org_study_id>ZGJAKT001</org_study_id>
    <nct_id>NCT04445363</nct_id>
  </id_info>
  <brief_title>A Study With Jaktinib Hydrochloride Cream Applied Topically to Subjects With Alopecia Areata</brief_title>
  <acronym>AA</acronym>
  <official_title>A Phase I/II Study Of The Efficacy,Safety and Pharmacokinetics Of Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Alopecia Areata</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(phase I) and a dose extension part(phase II).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In phase I of this study, a multi-center, randomized, placebo parallel control design was&#xD;
      adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo&#xD;
      group.A total of 40 subjects are expected to be enrolled in about 4 centers.&#xD;
&#xD;
      In phase II of this study, a multi-center, randomized, double-blind parallel,&#xD;
      placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the&#xD;
      experimental group or the placebo group.About 120 subjects are expected to be enrolled in&#xD;
      about 10 centers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 12, 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>
    <intervention_model_description>In phase I of this study, Forty enrolled subjects were randomly assigned to four groups at 1:1:1:1. (1) concentration of 0.5%, twice daily (Bid) group; (2) concentration of 1.5%, bid group; (3) concentration of 2.5%, oncedaily(Qd) group; (4) concentration of 2.5%, bid group.Ten subjects in each group were randomly assigned to receive Jaktinib hydrochloride cream (8 cases) and placebo (2 cases) at 4:1, respectively,The duration of administration was 24 weeks.&#xD;
In phase II of this trial, 120 Enrolled subjects are randomly assigned to 3 groups (placebo bid group,concentration of 1.5% bid group and concentration of 2.5% bid group).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)</measure>
    <time_frame>at week 24</time_frame>
    <description>SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Severity of Alopecia Tool (SALT) Score</measure>
    <time_frame>at baseline, at week 12 and at week 24</time_frame>
    <description>Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Alopecia Areata(AA)</condition>
  <arm_group>
    <arm_group_label>Cohort 1,0.5% Bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jaktinib hydrochloride cream 0.5% concentration, twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1,1.5% Bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jaktinib hydrochloride cream 1.5% concentration, twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1,2.5% Qd</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jaktinib hydrochloride cream 2.5% concentration, once daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1,2.5% Bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jaktinib hydrochloride cream 2.5% concentration, twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose extension: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose extension: 1.5% Bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jaktinib hydrochloride cream 1.5% concentration, twice daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose extension: 2.5% Bid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Jaktinib hydrochloride cream 2.5% concentration, twice daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Jaktinib hydrochloride cream</intervention_name>
    <description>Jaktinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks</description>
    <arm_group_label>Cohort 1,0.5% Bid</arm_group_label>
    <arm_group_label>Cohort 1,1.5% Bid</arm_group_label>
    <arm_group_label>Cohort 1,2.5% Bid</arm_group_label>
    <arm_group_label>Cohort 1,2.5% Qd</arm_group_label>
    <arm_group_label>Dose extension: 1.5% Bid</arm_group_label>
    <arm_group_label>Dose extension: 2.5% Bid</arm_group_label>
    <other_name>Jaktinib</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Dose extension: Placebo</description>
    <arm_group_label>Dose extension: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 ~ 65 years old (including boundary value), regardless of gender;&#xD;
&#xD;
          -  Diagnosis of Alopecia Areata;&#xD;
&#xD;
          -  Hair loss accounts for 5% ~ 49% of the total scalp area;&#xD;
&#xD;
          -  The duration of hair loss is at least 6 months, the longest is not more than 5 years;&#xD;
&#xD;
          -  Patients can complete treatment for at least 6 months;&#xD;
&#xD;
          -  About Fertility needs meet the following criteria: The results of serum pregnancy&#xD;
             tests performed by fertile women during screening visits must be negative, and the&#xD;
             results of human chorionic gonadotropin tests performed before the initiation of the&#xD;
             study drug must be negative;Women who were fertile and men who had not received&#xD;
             vasectomies were required to use effective contraception throughout the study period&#xD;
             beginning with the informed consent and up to six months after the last&#xD;
             administration;&#xD;
&#xD;
          -  Subjects will voluntarily participate in the study after learning about the content&#xD;
             and potential adverse drug reactions and must sign an IRC-approved informed consent&#xD;
             prior to beginning any examination required by the study;&#xD;
&#xD;
          -  Subject is willing and able to comply with scheduled visits, treatment plan, study&#xD;
             drug administration, and other study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The following causes of hair loss should be excluded: hair loss caused by androgenic&#xD;
             alopecia,syphilis, thyroid diseases, etc.&#xD;
&#xD;
          -  Acute Diffuse and Total Alopecia of the Female Scalp;&#xD;
&#xD;
          -  Prior history of serious chronic diseases, such as thyroid disease, liver disease,&#xD;
             malnutrition, heart disease, nervous system disease, gastrointestinal dysfunction,&#xD;
             tumor and mental illness, etc;&#xD;
&#xD;
          -  Human immunodeficiency virus infection, hepatitis C virus infection, hepatitis B virus&#xD;
             infection;&#xD;
&#xD;
          -  Participated in a trial for a topical or oral JAK inhibitor;&#xD;
&#xD;
          -  Allergic reactions to active ingredients or excipients are known or determined by the&#xD;
             investigator;&#xD;
&#xD;
          -  Receipt of treatment known to potentially affect the course of AA within last 3 month;&#xD;
&#xD;
          -  In the opinion of the investigator , the subject is inappropriate for entry into this&#xD;
             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>qianjin lu, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>the Second Xiangya Hospital, Central South University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>qianjin lu, M.D.</last_name>
    <phone>13787097676</phone>
    <email>qianlu5860@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>aijun chen, M.D.</last_name>
    <phone>13062377863</phone>
    <email>cajhx@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The second xaingya hospital ，central south university</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>qianjin Lu, MD</last_name>
      <phone>13787097676</phone>
      <email>qianlu5860@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>siqi Fu, MD</last_name>
      <phone>18874139898</phone>
      <email>18874139898@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>July 28, 2023</last_update_submitted>
  <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 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>Alopecia</mesh_term>
    <mesh_term>Alopecia Areata</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/NCT04445363
org study id: ZGJAKT001
nct id: NCT04445363
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study includes a dose escalation part(phase I) and a dose extension part(phase II).
In phase I of this study, a multi-center, randomized, placebo parallel control design was
      adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo
      group.A total of 40 subjects are expected to be enrolled in about 4 centers.

      In phase II of this study, a multi-center, randomized, double-blind parallel,
      placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the
      experimental group or the placebo group.About 120 subjects are expected to be enrolled in
      about 10 centers.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In phase I of this study, Forty enrolled subjects were randomly assigned to four groups at 1:1:1:1. (1) concentration of 0.5%, twice daily (Bid) group; (2) concentration of 1.5%, bid group; (3) concentration of 2.5%, oncedaily(Qd) group; (4) concentration of 2.5%, bid group.Ten subjects in each group were randomly assigned to receive Jaktinib hydrochloride cream (8 cases) and placebo (2 cases) at 4:1, respectively,The duration of administration was 24 weeks.
In phase II of this trial, 120 Enrolled subjects are randomly assigned to 3 groups (placebo bid group,concentration of 1.5% bid group and concentration of 2.5% bid group).
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Percentage of Participants Achieving 90% Improvement of Severity of Alopecia Tool (SALT90)
time frame: at week 24
description: SALT is a quantitative assessment of alopecia areata (AA) severity based on the scalp hair loss. A SALT 90 response is a 90% or greater reduction from baseline in SALT score. The SALT score can vary from 0 to 100%, with higher scores representing increasing severity of disease.
measure: Change in Severity of Alopecia Tool (SALT) Score
time frame: at baseline, at week 12 and at week 24
description: Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).
arm group label: Cohort 1,0.5% Bid
arm group type: Experimental
description: Jaktinib hydrochloride cream 0.5% concentration, twice daily
arm group label: Cohort 1,1.5% Bid
arm group type: Experimental
description: Jaktinib hydrochloride cream 1.5% concentration, twice daily
arm group label: Cohort 1,2.5% Qd
arm group type: Experimental
description: Jaktinib hydrochloride cream 2.5% concentration, once daily
arm group label: Cohort 1,2.5% Bid
arm group type: Experimental
description: Jaktinib hydrochloride cream 2.5% concentration, twice daily
arm group label: Dose extension: Placebo
arm group type: Placebo Comparator
description: Placebo, twice daily
arm group label: Dose extension: 1.5% Bid
arm group type: Experimental
description: Jaktinib hydrochloride cream 1.5% concentration, twice daily
arm group label: Dose extension: 2.5% Bid
arm group type: Experimental
description: Jaktinib hydrochloride cream 2.5% concentration, twice daily
intervention type: Drug
intervention name: Jaktinib hydrochloride cream
description: Jaktinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
arm group label: Cohort 1,0.5% Bid
arm group label: Cohort 1,1.5% Bid
arm group label: Cohort 1,2.5% Bid
arm group label: Cohort 1,2.5% Qd
arm group label: Dose extension: 1.5% Bid
arm group label: Dose extension: 2.5% Bid
other name: Jaktinib
intervention type: Drug
intervention name: Placebo
description: Dose extension: Placebo
arm group label: Dose extension: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: qianjin lu, M.D.
role: Study Chair
affiliation: the Second Xiangya Hospital, Central South University
last name: qianjin lu, M.D.
phone: 13787097676
email: qianlu5860@gmail.com
last name: aijun chen, M.D.
phone: 13062377863
email: cajhx@aliyun.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Alopecia
mesh term: Alopecia Areata