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/NCT06035354</url>
    </required_header>
    <id_info>
      <org_study_id>AK120-102</org_study_id>
      <nct_id>NCT06035354</nct_id>
    </id_info>
    <brief_title>A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis</brief_title>
    <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Akeso</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Akeso</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 is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical&#xD;
        study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of&#xD;
        subjects with moderate to severe atopic dermatitis.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical&#xD;
        study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with&#xD;
        moderate to severe atopic dermatitis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">November 3, 2021</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2024</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Phase Ib</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>Incidence of treatment emergent AE . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase Ib</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>T1/2 of AK120. Assessment of half-life(t1/2) of AK120.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase Ib</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>AUC of AK120. Assessment of Area under the curve(AUC) of AK120</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase Ib</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>Cmax of AK120. Assessment of Peak concentration(Cmax) of AK120</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase Ib</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>Tmax of AK120. Assessment of Time to peak(Tmax) of AK120</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase II</measure>
      <time_frame>at week 16</time_frame>
      <description>Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Phase II Extension Study</measure>
      <time_frame>Baseline to week 24</time_frame>
      <description>Incidence of treatment emergent AE . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Phase Ib</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>Percentage of subjects with detectable anti AK120 antibodies (ADA).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase Ib</measure>
      <time_frame>Baseline to week 12</time_frame>
      <description>Percentage of subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)(on a 6-point scale) .&#xD;
  Lower score of IGA mean better outcome, higher score mean worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase II</measure>
      <time_frame>Baseline to week 58</time_frame>
      <description>Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit.&#xD;
  Higher score mean better outcome, lower score mean worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase II</measure>
      <time_frame>Baseline to week 58</time_frame>
      <description>Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase II Extension Study</measure>
      <time_frame>Baseline to week 24</time_frame>
      <description>Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit.&#xD;
  Higher score mean better outcome, lower score mean worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Phase II Extension Study</measure>
      <time_frame>Baseline to week 24</time_frame>
      <description>Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome</description>
    </secondary_outcome>
    <number_of_arms>10</number_of_arms>
    <enrollment type="Anticipated">416</enrollment>
    <condition>Atopic Dermatitis</condition>
    <arm_group>
      <arm_group_label>AK120 150 mg in phase Ib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subcutaneous injection once a week for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AK120 300mg in phase Ib</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subcutaneous injection once a week for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Comparator: Placebo in phase Ib</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>subcutaneous injection once a week for 4 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AK120 150mg in phase II</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subcutaneous injection every 2 weeks for 50 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AK120 300mg in phase II</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subcutaneous injection every 2 weeks for 50 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AK120 450mg in phase II</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subcutaneous injection every 2 weeks for 50 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Comparator: Placebo in phase II</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AK120 150mg in phase II extension</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subcutaneous injection every 2 weeks for 14 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AK120 300mg in phase II extension</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subcutaneous injection every 2 weeks for 14 weeks.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>AK120 450mg in phase II extension</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>subcutaneous injection every 2 weeks for 14 weeks.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK120</intervention_name>
      <description>subcutaneous injection once a week</description>
      <arm_group_label>AK120 150 mg in phase Ib</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK120</intervention_name>
      <description>subcutaneous injection once a week</description>
      <arm_group_label>AK120 300mg in phase Ib</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>subcutaneous injection once a week.</description>
      <arm_group_label>Placebo Comparator: Placebo in phase Ib</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK120</intervention_name>
      <description>subcutaneous injection every 2 weeks.</description>
      <arm_group_label>AK120 150mg in phase II</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK120</intervention_name>
      <description>subcutaneous injection every 2 weeks.</description>
      <arm_group_label>AK120 300mg in phase II</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK120</intervention_name>
      <description>subcutaneous injection every 2 weeks.</description>
      <arm_group_label>AK120 450mg in phase II</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.</description>
      <arm_group_label>Placebo Comparator: Placebo in phase II</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK120</intervention_name>
      <description>subcutaneous injection every 2 weeks</description>
      <arm_group_label>AK120 150mg in phase II extension</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK120</intervention_name>
      <description>subcutaneous injection every 2 weeks.</description>
      <arm_group_label>AK120 300mg in phase II extension</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK120</intervention_name>
      <description>subcutaneous injection every 2 weeks.</description>
      <arm_group_label>AK120 450mg in phase II extension</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female with age 18 - 75 years (inclusive).&#xD;
  &#xD;
            2. Atopic dermatitis (AD) diagnosed at least half an year before screening.&#xD;
  &#xD;
            3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.&#xD;
  &#xD;
            4. Subjects with a history of an inadequate response or medically inappropriate use of&#xD;
               topical drug treatment within 6 months.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Suffering from other inflammatory diseases that may affect efficacy outcomes (such as&#xD;
               rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease,&#xD;
               scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome,&#xD;
               etc.).&#xD;
  &#xD;
            2. History of exposure to active TB, and/or history or current evidence of TB infection.&#xD;
  &#xD;
            3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.&#xD;
  &#xD;
            4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC)&#xD;
               within 6 months before the baseline visit.&#xD;
  &#xD;
            5. History of clinical parasite infection, recent or planned travel to an area with&#xD;
               endemic parasite infection within 6 months before the Screening visit&#xD;
  &#xD;
            6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in the&#xD;
               opinion of the Investigator or the Sponsor's medical monitor, would place the subject&#xD;
               at risk, interfere with participation in the study, or interfere with the&#xD;
               interpretation of study results.&#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_contact>
      <last_name>Guoqin Wang</last_name>
      <phone>+86 (0760) 8987 3999</phone>
      <email>global.trials@akesobio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College</name>
        <address>
          <city>Bengbu</city>
          <state>Anhui</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College</name>
        <address>
          <city>Wuhu</city>
          <state>Anhui</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 1001, Peking University People's Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2022, Dongguan People's Hospital</name>
        <address>
          <city>Dongguan</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University</name>
        <address>
          <city>Guiyang</city>
          <state>Guizhou</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University</name>
        <address>
          <city>Haikou</city>
          <state>Hainan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university</name>
        <address>
          <city>Chengde</city>
          <state>Hebei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital</name>
        <address>
          <city>Nanyang</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2051, Jingzhou Central Hospital</name>
        <address>
          <city>Jingzhou</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University</name>
        <address>
          <city>Hohhot</city>
          <state>Inner Mongolia</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou</name>
        <address>
          <city>Changzhou</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2050, Wuxi Second People's Hospital</name>
        <address>
          <city>Wuxi</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University</name>
        <address>
          <city>Zhenjiang</city>
          <state>Jiangsu</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College</name>
        <address>
          <city>Ganzhou</city>
          <state>Jiangxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2011, Northeast International Hospital</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2027, Medical School of Yanan University</name>
        <address>
          <city>Xianyang</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2029, West China Hospital，Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2034, Chengdu Second People's Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>AkesoBio Investigative Site 2009, The First Hospital of Jiaxing</name>
        <address>
          <city>Jiaxing</city>
          <state>Zhejiang</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 2, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06035354
  org study id: AK120-102
  nct id: NCT06035354
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical
        study to evaluate the safety, pharmacokinetics and efficacy of AK120 in the treatment of
        subjects with moderate to severe atopic dermatitis.
  This is a randomized, double-blind, placebo-controlled, multicenter phase Ib/II clinical
        study to evaluate the safety, pharmacokinetics and efficacy of AK120 in subjects with
        moderate to severe atopic dermatitis.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Phase Ib
  time frame: Baseline to week 12
  description: Incidence of treatment emergent AE . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
  measure: Phase Ib
  time frame: Baseline to week 12
  description: T1/2 of AK120. Assessment of half-life(t1/2) of AK120.
  measure: Phase Ib
  time frame: Baseline to week 12
  description: AUC of AK120. Assessment of Area under the curve(AUC) of AK120
  measure: Phase Ib
  time frame: Baseline to week 12
  description: Cmax of AK120. Assessment of Peak concentration(Cmax) of AK120
  measure: Phase Ib
  time frame: Baseline to week 12
  description: Tmax of AK120. Assessment of Time to peak(Tmax) of AK120
  measure: Phase II
  time frame: at week 16
  description: Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75
  measure: Phase II Extension Study
  time frame: Baseline to week 24
  description: Incidence of treatment emergent AE . An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment.
  measure: Phase Ib
  time frame: Baseline to week 12
  description: Percentage of subjects with detectable anti AK120 antibodies (ADA).
  measure: Phase Ib
  time frame: Baseline to week 12
  description: Percentage of subjects who achieved 0/1 in the Investigator's Global Assessment (IGA)(on a 6-point scale) .
  Lower score of IGA mean better outcome, higher score mean worse outcome
  measure: Phase II
  time frame: Baseline to week 58
  description: Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit.
  Higher score mean better outcome, lower score mean worse outcome
  measure: Phase II
  time frame: Baseline to week 58
  description: Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome
  measure: Phase II Extension Study
  time frame: Baseline to week 24
  description: Percentage of subjects who achieved EASI-50 (≥50% improvement from baseline) /EASI-75 (≥75% improvement from baseline) response at each visit.
  Higher score mean better outcome, lower score mean worse outcome
  measure: Phase II Extension Study
  time frame: Baseline to week 24
  description: Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome
  arm group label: AK120 150 mg in phase Ib
  arm group type: Experimental
  description: subcutaneous injection once a week for 4 weeks.
  arm group label: AK120 300mg in phase Ib
  arm group type: Experimental
  description: subcutaneous injection once a week for 4 weeks.
  arm group label: Placebo Comparator: Placebo in phase Ib
  arm group type: Placebo Comparator
  description: subcutaneous injection once a week for 4 weeks.
  arm group label: AK120 150mg in phase II
  arm group type: Experimental
  description: subcutaneous injection every 2 weeks for 50 weeks.
  arm group label: AK120 300mg in phase II
  arm group type: Experimental
  description: subcutaneous injection every 2 weeks for 50 weeks.
  arm group label: AK120 450mg in phase II
  arm group type: Experimental
  description: subcutaneous injection every 2 weeks for 50 weeks.
  arm group label: Placebo Comparator: Placebo in phase II
  arm group type: Placebo Comparator
  description: subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.
  arm group label: AK120 150mg in phase II extension
  arm group type: Experimental
  description: subcutaneous injection every 2 weeks for 14 weeks.
  arm group label: AK120 300mg in phase II extension
  arm group type: Experimental
  description: subcutaneous injection every 2 weeks for 14 weeks.
  arm group label: AK120 450mg in phase II extension
  arm group type: Experimental
  description: subcutaneous injection every 2 weeks for 14 weeks.
  intervention type: Drug
  intervention name: AK120
  description: subcutaneous injection once a week
  arm group label: AK120 150 mg in phase Ib
  intervention type: Drug
  intervention name: AK120
  description: subcutaneous injection once a week
  arm group label: AK120 300mg in phase Ib
  intervention type: Drug
  intervention name: Placebo
  description: subcutaneous injection once a week.
  arm group label: Placebo Comparator: Placebo in phase Ib
  intervention type: Drug
  intervention name: AK120
  description: subcutaneous injection every 2 weeks.
  arm group label: AK120 150mg in phase II
  intervention type: Drug
  intervention name: AK120
  description: subcutaneous injection every 2 weeks.
  arm group label: AK120 300mg in phase II
  intervention type: Drug
  intervention name: AK120
  description: subcutaneous injection every 2 weeks.
  arm group label: AK120 450mg in phase II
  intervention type: Drug
  intervention name: Placebo
  description: subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5.
  arm group label: Placebo Comparator: Placebo in phase II
  intervention type: Drug
  intervention name: AK120
  description: subcutaneous injection every 2 weeks
  arm group label: AK120 150mg in phase II extension
  intervention type: Drug
  intervention name: AK120
  description: subcutaneous injection every 2 weeks.
  arm group label: AK120 300mg in phase II extension
  intervention type: Drug
  intervention name: AK120
  description: subcutaneous injection every 2 weeks.
  arm group label: AK120 450mg in phase II extension
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Guoqin Wang
  phone: +86 (0760) 8987 3999
  email: global.trials@akesobio.com
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  facility: 
  status: Recruiting
  country: China
  responsible party type: Sponsor
  mesh term: Dermatitis, Atopic
  mesh term: Dermatitis
  mesh term: Eczema
  sharing ipd: No