nctId: NCT06383468 id: AK120-301 briefTitle: A Phase III Study to Evaluate the Efficacy and Safety of AK120 in Patients With Moderate to Severe Atopic Dermatitis overallStatus: RECRUITING date: 2024-04-30 date: 2025-01-30 date: 2026-01-30 date: 2024-04-25 date: 2024-04-25 name: Akeso class: INDUSTRY briefSummary: This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 420 type: ESTIMATED name: AK120 measure: Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75 measure: Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA sex: ALL minimumAge: 18 Years maximumAge: 75 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Beijing Friendship Hospital Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Luhe Hospital Affiliated to Capital Medical University status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Beijing Tongren Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital status: RECRUITING city: Beijing state: Beijing country: China lat: 39.9075 lon: 116.39723 facility: Chongqing Three Gorges Medical College Affiliated People's Hospital status: RECRUITING city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: Chongqing Traditional Chinese Medicine Hospital status: RECRUITING city: Chongqing state: Chongqing country: China lat: 29.56278 lon: 106.55278 facility: The First Affiliated Hospital of Fujian Medical University status: RECRUITING city: Fuzhou state: Fujian country: China lat: 26.06139 lon: 119.30611 facility: The Second Affiliated Hospital of Xiamen Medical College status: RECRUITING city: Xiamen state: Fujian country: China lat: 24.47979 lon: 118.08187 facility: Guangdong Provincial People's Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Southern Medical University Southern Hospital status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital of Guangzhou Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Zhujiang Hospital of Southern Medical University status: RECRUITING city: Guangzhou state: Guangdong country: China lat: 23.11667 lon: 113.25 facility: Yuebei People's hospital, Guangdong, China status: RECRUITING city: Shaoguan state: Guangdong country: China lat: 24.8 lon: 113.58333 facility: Shunde Hospital of Southern Medical University status: RECRUITING city: Shunde state: Guangdong country: China lat: 22.84067 lon: 113.2503 facility: Guangdong Medical University Affiliated Hospital status: RECRUITING city: Zhanjiang state: Guangdong country: China lat: 21.28145 lon: 110.34271 facility: The Affiliated Hospital of Guizhou Medical University status: RECRUITING city: Guiyang state: Guizhou country: China lat: 26.58333 lon: 106.71667 facility: Hainan General Hospital status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: Hainan Provincial Fifth People's Hospital status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: The First Affiliated Hospital of Hainan Medical College status: RECRUITING city: Haikou state: Hainan country: China lat: 20.04583 lon: 110.34167 facility: Chengde Medical College Affiliated Hospital status: RECRUITING city: Chengde state: Hebei country: China lat: 40.9519 lon: 117.95883 facility: The Second Affiliated Hospital of Xingtai Medical College status: RECRUITING city: Xingtai state: Hebei country: China lat: 37.06306 lon: 114.49417 facility: Harbin Medical University Affiliated Second Hospital status: RECRUITING city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: Heilongjiang Provincial Hospital status: RECRUITING city: Harbin state: Heilongjiang country: China lat: 45.75 lon: 126.65 facility: The Second Affiliated Hospital of Henan University of Science and Technology status: RECRUITING city: Luoyang state: Henan country: China lat: 34.68361 lon: 112.45361 facility: Renmin Hospital of Wuhan University Hubei General Hospital status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei country: China lat: 30.58333 lon: 114.26667 facility: Changde First People's Hospital status: RECRUITING city: Changde state: Hunan country: China lat: 29.04638 lon: 111.6783 facility: Xiangya Hospital of Central South University status: RECRUITING city: Changsha state: Hunan country: China lat: 28.19874 lon: 112.97087 facility: The First Affiliated Hospital of South China University status: RECRUITING city: Hengyang state: Hunan country: China lat: 26.88946 lon: 112.61888 facility: Inner Mongolia Medical University Affiliated Hospital status: RECRUITING city: Hohhot state: Inner Mongolia country: China lat: 40.81056 lon: 111.65222 facility: The First Affiliated Hospital of Bengbu Medical College status: RECRUITING city: Bengbu state: Jiangsu country: China lat: 32.94083 lon: 117.36083 facility: Changzhou First People's Hospital status: RECRUITING city: Changzhou state: Jiangsu country: China lat: 31.77359 lon: 119.95401 facility: Yancheng First People's Hospital status: RECRUITING city: Yancheng state: Jiangsu country: China lat: 33.3575 lon: 120.1573 facility: Jiangsu University Affiliated Hospital status: RECRUITING city: Zhenjiang state: Jiangsu country: China lat: 32.21086 lon: 119.45508 facility: The First Affiliated Hospital of Gannan Medical College status: RECRUITING city: Ganzhou state: Jiangxi country: China facility: The First Bethune Hospital of Jilin University status: RECRUITING city: Changchun state: Jilin country: China lat: 43.88 lon: 125.32278 facility: Panjin Liaoyou Gemstone Flower Hospital status: RECRUITING city: Panjin state: Liaoning country: China lat: 41.121 lon: 122.0739 facility: Shenyang Integrated Traditional Chinese and Western Medicine Hospital status: RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: Zhongyi Northeast International Hospital status: RECRUITING city: Shenyang state: Liaoning country: China lat: 41.79222 lon: 123.43278 facility: General Hospital of Ningxia Medical University status: RECRUITING city: Yinchuan state: Ningxia country: China lat: 38.46806 lon: 106.27306 facility: Shandong Provincial Dermatology Hospital status: RECRUITING city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: Shandong University Qilu Hospital status: RECRUITING city: Jinan state: Shandong country: China lat: 36.66833 lon: 116.99722 facility: Qingdao Municipal Hospital status: RECRUITING city: Qingdao state: Shandong country: China lat: 36.06488 lon: 120.38042 facility: Shanghai Dermatology Hospital status: RECRUITING city: Shanghai state: Shanghai country: China lat: 31.22222 lon: 121.45806 facility: Baoji Central Hospital status: RECRUITING city: Baoji state: Shanxi country: China facility: Sichuan Provincial People's Hospital status: RECRUITING city: Chengdu state: Sichuan country: China lat: 30.66667 lon: 104.06667 facility: Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital status: RECRUITING city: Tianjin state: Tianjin country: China lat: 39.14222 lon: 117.17667 facility: Xinjiang Uygur Autonomous Region People's Hospital status: RECRUITING city: Urumqi state: Xinjiang country: China lat: 43.80096 lon: 87.60046 facility: The First Affiliated Hospital of Kunming Medical University status: RECRUITING city: Kunming state: Yunnan country: China lat: 25.03889 lon: 102.71833 facility: Hangzhou First People's Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 facility: Hangzhou Third People's Hospital status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine status: RECRUITING city: Hangzhou state: Zhejiang country: China lat: 30.29365 lon: 120.16142 facility: Jiaxing First People's Hospital status: RECRUITING city: Jiaxing state: Zhejiang country: China lat: 30.7522 lon: 120.75 facility: Ningbo First Hospital status: RECRUITING city: Ningbo state: Zhejiang country: China lat: 29.87819 lon: 121.54945 facility: Ningbo Huamei Hospital, University of Chinese Academy of Sciences status: RECRUITING city: Ningbo state: Zhejiang country: China lat: 29.87819 lon: 121.54945 facility: Wenzhou Medical University First Affiliated Hospital status: RECRUITING city: Wenzhou state: Zhejiang country: China lat: 27.99942 lon: 120.66682 hasResults: False