A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis
Atopic Dermatitis
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
Inclusion Criteria: Male or female with age 18 - 75 years (inclusive). Atopic dermatitis (AD) diagnosed at least half an year before screening. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline. Subjects with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months. Exclusion Criteria: Suffering from other inflammatory diseases that may affect efficacy outcomes (such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.). History of exposure to active TB, and/or history or current evidence of TB infection. Positive serology results at Screening for hepatitis B, hepatitis C or HIV. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit. History of clinical parasite infection, recent or planned travel to an area with endemic parasite infection within 6 months before the Screening visit Any medical or psychiatric condition, laboratory, or ECG parameter which, in the opinion of the Investigator or the Sponsor's medical monitor, would place the subject at risk, interfere with participation in the study, or interfere with the interpretation of study results.
Sites / Locations
- AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical CollegeRecruiting
- AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical CollegeRecruiting
- AkesoBio Investigative Site 1001, Peking University People's HospitalRecruiting
- AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical UniversityRecruiting
- AkesoBio Investigative Site 2023, Xinqiao Hospital Medical UniversityRecruiting
- AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical CollegeRecruiting
- AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine HospitalRecruiting
- AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
- AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical UniversityRecruiting
- AkesoBio Investigative Site 2022, Dongguan People's HospitalRecruiting
- AkesoBio Investigative Site 1002, Guangdong Provincial People's HospitalRecruiting
- AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical UniversityRecruiting
- AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical UniversityRecruiting
- AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical UniversityRecruiting
- AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical universityRecruiting
- AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A HospitalRecruiting
- AkesoBio Investigative Site 2051, Jingzhou Central HospitalRecruiting
- AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South UniversityRecruiting
- AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical UniversityRecruiting
- AkesoBio Investigative Site 2048, The First People's Hospital of ChangzhouRecruiting
- AkesoBio Investigative Site 2050, Wuxi Second People's HospitalRecruiting
- AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu UniversityRecruiting
- AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical CollegeRecruiting
- AkesoBio Investigative Site 2011, Northeast International HospitalRecruiting
- AkesoBio Investigative Site 2039, Shandong Provincial Dermatology HospitalRecruiting
- AkesoBio Investigative Site 2041, Qilu Hospital of Shandong UniversityRecruiting
- AkesoBio Investigative Site 1003, Shanghai Skin Disease HospitalRecruiting
- AkesoBio Investigative Site 2027, Medical School of Yanan UniversityRecruiting
- AkesoBio Investigative Site 2029, West China Hospital,Sichuan UniversityRecruiting
- AkesoBio Investigative Site 2034, Chengdu Second People's HospitalRecruiting
- AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated HospitalRecruiting
- AkesoBio Investigative Site 2019, Tianjin Medical University General HospitalRecruiting
- AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical UniversityRecruiting
- AkesoBio Investigative Site 1004, Zhejiang Provincial People's HospitalRecruiting
- AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's HospitalRecruiting
- AkesoBio Investigative Site 2007, Hangzhou Third People's HospitalRecruiting
- AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of MedicineRecruiting
- AkesoBio Investigative Site 2009, The First Hospital of JiaxingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm 10
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Experimental
AK120 150 mg in phase Ib
AK120 300mg in phase Ib
Placebo Comparator: Placebo in phase Ib
AK120 150mg in phase II
AK120 300mg in phase II
AK120 450mg in phase II
Placebo Comparator: Placebo in phase II
AK120 150mg in phase II extension
AK120 300mg in phase II extension
AK120 450mg in phase II extension
subcutaneous injection once a week for 4 weeks.
subcutaneous injection once a week for 4 weeks.
subcutaneous injection once a week for 4 weeks.
subcutaneous injection every 2 weeks for 50 weeks.
subcutaneous injection every 2 weeks for 50 weeks.
subcutaneous injection every 2 weeks for 50 weeks.
subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation.
subcutaneous injection every 2 weeks for 14 weeks.
subcutaneous injection every 2 weeks for 14 weeks.
subcutaneous injection every 2 weeks for 14 weeks.