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NCT06767540Not yet recruitingPhase 3

A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis

A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents

Source: ClinicalTrials.gov · Last updated 10 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
198 (estimated)
First submitted
8 Jan 2025
Start date
23 Jan 2025
Primary completion date
10 Jul 2027
Lead sponsor
Akeso
NCT number
NCT06767540

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 198
  • From 23 Jan 2025 to the primary completion date, 10 Jul 2027
  • 28 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

  • Acute onset of AD in 4 weeks prior to enrollment.
  • Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
  • Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
  • Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization.
  • Received treatment with other clinical study drugs within 4 weeks or 5 halflives before randomization (whichever is longer).

Other illness

  • Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Who the study is looking for

  • Male or female subjects aged ≥12\<18 years old, weight ≥ 30kg.
  • AD diagnosed at least half a year before screening.
  • Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
  • Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.

Age in the registry: 12 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (28)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Peking University People's Hospital
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BeijingChinaUnknown status
Hunan Children's Hospital
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ChangshaChinaUnknown status
XiangYa Hospital CentralSouth University
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ChangshaChinaUnknown status
Sichuan Provincial People's Hospital
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ChengduChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Chongqing Traditional Chinese Medicine Hospital
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ChongqingChinaUnknown status
Dongguan People's Hospital
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DongguanChinaUnknown status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
Dermatology Hospital of Southern Medical University
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GuangzhouChinaUnknown status
The second Affiliated Hospital of Guangzhou Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital of Jinan University
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GuangzhouChinaUnknown status
Jiangmen Central Hospital
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JiangmenChinaUnknown status
The First Hospital Of Jiaxing
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JiaxingChinaUnknown status
Shandong Provincial Dermatology Hospital
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JinanChinaUnknown status
Jining First People's Hospital
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JiningChinaUnknown status
Jinzhou Central Hospital
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JinzhouChinaUnknown status
The First Affiliated Hospital of Kunming Medical University
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KunmingChinaUnknown status
Liuzhou Worker's Hospital
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LiuzhouChinaUnknown status
Dermatology Hospital of Jiangxi Province
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NanchangChinaUnknown status
Shanghai Skin Disease Hospital
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ShanghaiChinaUnknown status
LongHua Hospital Shanghai University of Traditional Chinese Medicine
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ShanghaiChinaUnknown status
Huashan Hospital, Fudan University
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ShanghaiChinaUnknown status
The University of Hong Kong-Shenzhen Hospital
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ShenzhenChinaUnknown status
Tongji Hospital
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WuhanChinaUnknown status
the Second Affiliated Hospital of Wannan Medical College
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WuhuChinaUnknown status
The First Affiliated Hospital of Xi'an Jiao Tong University
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Xi’anChinaUnknown status
Affiliated Hospital of Jiangsu University
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ZhenjiangChinaUnknown status
The Third People's Hospital of Zhuhai
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ZhuhaiChinaUnknown status

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