xml: <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/NCT05997927</url>
    </required_header>
    <id_info>
      <org_study_id>VC005-202</org_study_id>
      <nct_id>NCT05997927</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety Clinical Study of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis</brief_title>
    <official_title>A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Tablets in Adult Patients With Moderate to Severe Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jiangsu vcare pharmaceutical technology co., LTD</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Jiangsu vcare pharmaceutical technology co., LTD</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This clinical trial is a multicenter, randomized, double-blind, controlled phase II clinical&#xD;
        study.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">August 23, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 23, 2026</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>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage change from baseline in EASI score</measure>
      <time_frame>week 12</time_frame>
      <description>Percentage change from baseline in EASI score at week 12</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">152</enrollment>
    <condition>Moderate to Severe Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>VC005 Tablets Low Dose groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>VC005 Tablets Medium Dose groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>VC005 Tablets High Dose groups</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>VC005 Tablets Placebo groups</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VC005 tablets</intervention_name>
      <description>VC005 groups repeat administration for 12 weeks</description>
      <arm_group_label>VC005 Tablets High Dose groups</arm_group_label>
      <arm_group_label>VC005 Tablets Low Dose groups</arm_group_label>
      <arm_group_label>VC005 Tablets Medium Dose groups</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>VC005 Tablets Placebo</intervention_name>
      <description>VC005 placebo groups repeat administration for 12 weeks</description>
      <arm_group_label>VC005 Tablets High Dose groups</arm_group_label>
      <arm_group_label>VC005 Tablets Low Dose groups</arm_group_label>
      <arm_group_label>VC005 Tablets Medium Dose groups</arm_group_label>
      <arm_group_label>VC005 Tablets Placebo groups</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The patient understands and voluntarily signs the Informed Consent Form (ICF), and has&#xD;
               the willingness and ability to complete the regular visits, treatment plans,&#xD;
               laboratory tests and other experimental procedures required by the program.&#xD;
  &#xD;
            2. Male or female patients aged ≥18 and ≤75 years at the time of signing the ICF.&#xD;
  &#xD;
            3. Meet Hanifin-Rajka diagnostic criteria at screening and have atopic dermatitis （AD)&#xD;
               symptoms for at least 1 year prior to baseline.&#xD;
  &#xD;
            4. At screening and baseline, meets criteria for moderately severe AD based on the&#xD;
               investigator's assessment of 3 of the following:Eczema area and severity index (EASI)&#xD;
               score ≥12;Psoriasis Area Severity Index (IGA) score ≥3;AD involvement in ≥10% of the&#xD;
               Body Surface Area (BSA).&#xD;
  &#xD;
            5. Recent (within 1 year prior to screening) topical treatment for AD with inadequate or&#xD;
               intolerant clinical response, as determined by the investigator.&#xD;
  &#xD;
            6. Able and willing to use only stabilized doses of emollients that do not contain&#xD;
               ingredients that interfere with the evaluation of efficacy, uniformly provided by the&#xD;
               Sponsor, beginning at least 7 days prior to Baseline and continuing for the duration&#xD;
               of the study.&#xD;
  &#xD;
            7. Non-lactating female patients of child-bearing potential (WOCBP) who have a negative&#xD;
               pregnancy test at Screening and who are committed to adequate and effective&#xD;
               contraception or abstinence for the duration of the study as well as for 28 days after&#xD;
               completion of treatment with the investigational medicinal product.&#xD;
  &#xD;
            8. Male patients commit to use adequate and effective contraception or abstinence for the&#xD;
               duration of the study and for 28 days after completion of treatment with the&#xD;
               investigational drug. In addition, male patients must agree that they will not donate&#xD;
               sperm during this period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
  &#xD;
          1. Presence of the following diseases or history of disease:&#xD;
  &#xD;
            1. Inability to swallow the test drug or refractory nausea and vomiting, malabsorption,&#xD;
               extracorporeal biliary shunt, or the presence of a gastrointestinal disorder (e.g.,&#xD;
               Crohn's disease, ulcerative colitis, or short bowel syndrome) or other malabsorption&#xD;
               condition that interferes with the absorption of the drug;&#xD;
  &#xD;
            2. Current or history of lymphoproliferative disorders or presence of signs or symptoms&#xD;
               suggestive of possible lymphoproliferative disorders of lymphoid tissue, including&#xD;
               lymphadenopathy or splenomegaly; malignancies of any kind, or a history of any&#xD;
               malignancy within the 5 years prior to Screening (except for completely resected&#xD;
               carcinoma in situ of the cervix or non-metastatic squamous cell or basal cell&#xD;
               carcinoma of the skin or papillary carcinoma of the thyroid gland);&#xD;
  &#xD;
            3. Patients with prior thromboembolism (including deep vein thrombosis, pulmonary&#xD;
               embolism, arterial thrombosis, etc.) or other high-risk groups prone to&#xD;
               thromboembolism;&#xD;
  &#xD;
            4. Patients with a history of herpes virus infection within the last 1 month or those&#xD;
               with recurrent episodes of herpes zoster (≥2), disseminated herpes zoster,&#xD;
               disseminated herpes simplex, or those for whom herpes zoster or herpes simplex&#xD;
               infections cannot be excluded at this time;&#xD;
  &#xD;
            5. History of any persistent or chronic infection at screening or prior to randomization&#xD;
               (e.g., chronic pyelonephritis, chronic bronchitis) or presence of other infections&#xD;
               judged unsuitable for enrollment in this study by the investigator; history of deep&#xD;
               interstitial/tissue infections (e.g., fasciitis, abscess, osteomyelitis) within 12&#xD;
               months prior to baseline; history of conditionally causative bacterial infections&#xD;
               (e.g., cytomegalovirus infections, pulmonary Aspergillosis, etc.); history of&#xD;
               hospitalized infections (viral, bacterial, fungal, parasitic, etc.) within 3 months&#xD;
               prior to baseline;&#xD;
  &#xD;
            6. Immunodeficiency diseases or first-degree relatives with hereditary immunodeficiency&#xD;
               diseases; etc.&#xD;
  &#xD;
          2. Any one of the laboratory test indicators at the screening test meets the following&#xD;
          criteria:&#xD;
  &#xD;
          (1) White blood cell count (WBC) &lt;3×109/L, absolute neutrophil count (ANC) &lt;1.5×109/L,&#xD;
          absolute lymphocyte count (ALC) &lt;0.8×109/L, platelet (PLT) &lt;100×109/L, hemoglobin (Hb) &lt;90&#xD;
          g/L; etc; 3. Being on/taking or have a history of the following treatments/medications:&#xD;
  &#xD;
            1. Use of systemic anti-infective drugs within 14 days prior to baseline;&#xD;
  &#xD;
            2. Use of any AD topical therapy, including but not limited to topical corticosteroid&#xD;
               (TCS), topical calcineurin inhibitors (TCI), phosphodiesterase (PDE) inhibitors,Janus&#xD;
               kinase inhibitors, within 2 weeks prior to baseline;&#xD;
  &#xD;
            3. Use of any kind of systemic systemic therapy for AD, including but not limited to&#xD;
               immunosuppressants, corticosteroids, phosphodiesterase 4 (PDE4) inhibitors, and&#xD;
               participation in other interventional clinical trials with an indication of AD within&#xD;
               4 weeks (or 5 t1/2, whichever is longer) prior to Baseline;&#xD;
  &#xD;
            4. Subjects with a positive test result on the gamma-interferon (IFN-γ) release assay&#xD;
               (QUANTIFERON®-TB GOLD or T-SPOT.TB®) at Screening, with the exception of those who, in&#xD;
               the judgment of the Investigator, require prophylaxis and have been on prophylaxis for&#xD;
               ≥ 4 weeks.&#xD;
  &#xD;
          5. Substantial blood loss, receipt of blood transfusion, or blood donation (≥400 mL) within&#xD;
          3 months prior to baseline.&#xD;
  &#xD;
          6、 Known or suspected allergy to the main components and excipients of VC005 or similar&#xD;
          drugs.&#xD;
  &#xD;
          7. Women who are planning to become pregnant, pregnant or breastfeeding. 8, History of&#xD;
          alcohol abuse [&gt;14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL&#xD;
          of spirits with 40% alcohol content or 150 mL of wine)] in the 6 months prior to baseline&#xD;
          that cannot be stopped during the trial.&#xD;
  &#xD;
          9. Patients who, in the judgment of the investigator, have other reasons that make them&#xD;
          unsuitable for participation in this clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qianjin Lu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Chinese Academy of Medical Sciences Hospital of Skin Disease</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xiaojuan Lai</last_name>
      <phone>15358160458</phone>
      <email>lai_xiaojuan@vcarepharmatech.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chinese Academy of Medical Sciences Hospital for Skin Diseases</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210042</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qianjin Lu</last_name>
        <phone>13787097676</phone>
        <email>qianlu5860@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>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>
  
  
text: 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/NCT05997927
  org study id: VC005-202
  nct id: NCT05997927
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This clinical trial is a multicenter, randomized, double-blind, controlled phase II clinical
        study.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Percentage change from baseline in EASI score
  time frame: week 12
  description: Percentage change from baseline in EASI score at week 12
  arm group label: VC005 Tablets Low Dose groups
  arm group type: Experimental
  arm group label: VC005 Tablets Medium Dose groups
  arm group type: Experimental
  arm group label: VC005 Tablets High Dose groups
  arm group type: Experimental
  arm group label: VC005 Tablets Placebo groups
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: VC005 tablets
  description: VC005 groups repeat administration for 12 weeks
  arm group label: VC005 Tablets High Dose groups
  arm group label: VC005 Tablets Low Dose groups
  arm group label: VC005 Tablets Medium Dose groups
  intervention type: Drug
  intervention name: VC005 Tablets Placebo
  description: VC005 placebo groups repeat administration for 12 weeks
  arm group label: VC005 Tablets High Dose groups
  arm group label: VC005 Tablets Low Dose groups
  arm group label: VC005 Tablets Medium Dose groups
  arm group label: VC005 Tablets Placebo groups
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Qianjin Lu
  role: Principal Investigator
  affiliation: Chinese Academy of Medical Sciences Hospital of Skin Disease
  last name: Xiaojuan Lai
  phone: 15358160458
  email: lai_xiaojuan@vcarepharmatech.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema