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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AK120 150 mg in phase Ib | Experimental | subcutaneous injection once a week for 4 weeks. |
|
| AK120 300mg in phase Ib | Experimental | subcutaneous injection once a week for 4 weeks. |
|
| Placebo Comparator: Placebo in phase Ib | Placebo Comparator | subcutaneous injection once a week for 4 weeks. |
|
| AK120 150mg in phase II | Experimental | subcutaneous injection every 2 weeks for 50 weeks. |
|
| AK120 300mg in phase II | Experimental | subcutaneous injection every 2 weeks for 50 weeks. |
|
| AK120 450mg in phase II | Experimental | subcutaneous injection every 2 weeks for 50 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AK120 | Drug | subcutaneous injection once a week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib | 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. | Baseline to week 12 |
| Phase Ib | T1/2 of AK120. Assessment of half-life(t1/2) of AK120. | Baseline to week 12 |
| Phase Ib | AUC of AK120. Assessment of Area under the curve(AUC) of AK120 | Baseline to week 12 |
| Phase Ib | Cmax of AK120. Assessment of Peak concentration(Cmax) of AK120 | Baseline to week 12 |
| Phase Ib | Tmax of AK120. Assessment of Time to peak(Tmax) of AK120 | Baseline to week 12 |
| Phase II | Percentage of subjects who achieved (Eczema Area and Severity Index)EASI-75 | at week 16 |
| Phase II Extension Study | 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. | Baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Phase Ib | Percentage of subjects with detectable anti AK120 antibodies (ADA). | Baseline to week 12 |
| Phase Ib | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China | |||
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Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
| Placebo Comparator: Placebo in phase II | Placebo Comparator | subcutaneous injection every 2 weeks, then crossover to AK120 Regimen 4 and Regimen 5, subcutaneous injection at week 16, after primary endpoint evaluation. |
|
| AK120 150mg in phase II extension | Experimental | subcutaneous injection every 2 weeks for 14 weeks. |
|
| AK120 300mg in phase II extension | Experimental | subcutaneous injection every 2 weeks for 14 weeks. |
|
| AK120 450mg in phase II extension | Experimental | subcutaneous injection every 2 weeks for 14 weeks. |
|
| AK120 |
| Drug |
subcutaneous injection once a week |
|
| Placebo | Drug | subcutaneous injection once a week. |
|
| AK120 | Drug | subcutaneous injection every 2 weeks. |
|
| AK120 | Drug | subcutaneous injection every 2 weeks. |
|
| AK120 | Drug | subcutaneous injection every 2 weeks. |
|
| Placebo | Drug | subcutaneous injection every 2 weeks for 16 weeks then crossover to AK120 Regimen 4 and Regimen 5. |
|
| AK120 | Drug | subcutaneous injection every 2 weeks |
|
| AK120 | Drug | subcutaneous injection every 2 weeks. |
|
| AK120 | Drug | subcutaneous injection every 2 weeks. |
|
| Baseline to week 12 |
| Phase II | 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 | Baseline to week 58 |
| Phase II | Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome | Baseline to week 58 |
| Phase II Extension Study | 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 | Baseline to week 24 |
| Phase II Extension Study | Percentage change in EASI scores from baseline at each visit. Higher score mean better outcome, lower score mean worse outcome | Baseline to week 24 |
| AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College |
| Wuhu |
| Anhui |
| China |
| AkesoBio Investigative Site 1001, Peking University People's Hospital | Beijing | Beijing Municipality | China |
| AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | China |
| AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University | Chongqing | Chongqing Municipality | China |
| AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College | Chongqing | Chongqing Municipality | China |
| AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital | Chongqing | Chongqing Municipality | China |
| AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | China |
| AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| AkesoBio Investigative Site 2022, Dongguan People's Hospital | Dongguan | Guangdong | China |
| AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital | Guangzhou | Guangdong | China |
| AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | China |
| AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University | Haikou | Hainan | China |
| AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university | Chengde | Hebei | China |
| AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital | Nanyang | Henan | China |
| AkesoBio Investigative Site 2051, Jingzhou Central Hospital | Jingzhou | Hubei | China |
| AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei | China |
| AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | Inner Mongolia | China |
| AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou | Changzhou | Jiangsu | China |
| AkesoBio Investigative Site 2050, Wuxi Second People's Hospital | Wuxi | Jiangsu | China |
| AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College | Ganzhou | Jiangxi | China |
| AkesoBio Investigative Site 2011, Northeast International Hospital | Shenyang | Liaoning | China |
| AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital | Jinan | Shandong | China |
| AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University | Jinan | Shandong | China |
| AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | China |
| AkesoBio Investigative Site 2027, Medical School of Yanan University | Xianyang | Shanxi | China |
| AkesoBio Investigative Site 2029, West China Hospital,Sichuan University | Chengdu | Sichuan | China |
| AkesoBio Investigative Site 2034, Chengdu Second People's Hospital | Chengdu | Sichuan | China |
| AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | China |
| AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | China |
| AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | China |
| AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
| AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital | Hangzhou | Zhejiang | China |
| AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| AkesoBio Investigative Site 2009, The First Hospital of Jiaxing | Jiaxing | Zhejiang | China |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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