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