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NCT06035354CompletedPhase 1/2

A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AK120 in Subjects With Atopic Dermatitis

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

Source: ClinicalTrials.gov · Last updated 5 Mar 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
427 (actual)
First submitted
2 Jun 2023
Start date
3 Nov 2021
Primary completion date
21 Jun 2024
Lead sponsor
Akeso
NCT number
NCT06035354

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 427
  • From 3 Nov 2021 to the primary completion date, 21 Jun 2024
  • 39 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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.

Lab values

  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (39)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
AkesoBio Investigative Site 1001, Peking University People's Hospital
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BeijingChinaUnknown status
AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College
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BengbuChinaUnknown status
AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou
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ChangzhouChinaUnknown status
AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university
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ChengdeChinaUnknown status
AkesoBio Investigative Site 2029, West China Hospital,Sichuan University
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ChengduChinaUnknown status
AkesoBio Investigative Site 2034, Chengdu Second People's Hospital
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ChengduChinaUnknown status
AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital
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ChongqingChinaUnknown status
AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College
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ChongqingChinaUnknown status
AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University
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ChongqingChinaUnknown status
AkesoBio Investigative Site 2022, Dongguan People's Hospital
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DongguanChinaUnknown status
AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College
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GanzhouChinaUnknown status
AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University
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GuangzhouChinaUnknown status
AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital
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GuangzhouChinaUnknown status
AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University
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GuiyangChinaUnknown status
AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University
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HaikouChinaUnknown status
AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital
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HangzhouChinaUnknown status
AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital
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HangzhouChinaUnknown status
AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital
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HangzhouChinaUnknown status
AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University
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HohhotChinaUnknown status
AkesoBio Investigative Site 2009, The First Hospital of Jiaxing
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JiaxingChinaUnknown status
AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University
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JinanChinaUnknown status
AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital
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JinanChinaUnknown status
AkesoBio Investigative Site 2051, Jingzhou Central Hospital
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JingzhouChinaUnknown status
AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital
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NanyangChinaUnknown status
AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital
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ShanghaiChinaUnknown status
AkesoBio Investigative Site 2011, Northeast International Hospital
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ShenyangChinaUnknown status
AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
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TianjinChinaUnknown status
AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital
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TianjinChinaUnknown status
AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College
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WuhuChinaUnknown status
AkesoBio Investigative Site 2050, Wuxi Second People's Hospital
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WuxiChinaUnknown status
AkesoBio Investigative Site 2027, Medical School of Yanan University
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XianyangChinaUnknown status
AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.