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NCT06092762CompletedPhase 2

A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis

a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis

Source: ClinicalTrials.gov · Last updated 25 Nov 2024

Brief summary (registry, in English)

This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy of AK120 in the treatment of subjects with moderate to severe atopic dermatitis.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
180 (actual)
First submitted
16 Oct 2023
Start date
6 Nov 2023
Primary completion date
13 Nov 2024
Lead sponsor
Akeso
NCT number
NCT06092762

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 180
  • From 6 Nov 2023 to the primary completion date, 13 Nov 2024
  • 26 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

  • Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
  • 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 1 month or 5 half-lives before randomization (whichever is longer)
  • Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
  • Received allergen specific immunotherapy within the 3 months before randomization.

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 ≥18≤75 years old.
  • Atopic dermatitis (AD) diagnosed at least half a 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 (26)

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

SiteCityCountrySite status
Baoji Central Hospital
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BaojiChinaUnknown status
China-Japan Friendship Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Air Force Medical Center
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BeijingChinaUnknown 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
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Affiliated Hospital of Nantong University
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NantongChinaUnknown status
Ningbo No.2 Hospital
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NingboChinaUnknown status
QingDao Municipal Hospital
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QingdaoChinaUnknown status
Shenzhen People's Hospital
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ShenzhenChinaUnknown status
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
Second hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
Taiyuan Central Hospital
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TaiyuanChinaUnknown status
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
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TianjinChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Renmin Hospital of Wuhan University/Hubei General Hospital
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WuhanChinaUnknown status
The Second Affiliated Hospital of Xiamen Medical College
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XiamenChinaUnknown status
People Hospital of Xingtai
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XingtaiChinaUnknown status
Yancheng NO.1 People's Hospital
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YanchengChinaUnknown status
General Hospital of Ningxia Medical University
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YinchuanChinaUnknown status
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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YiwuChinaUnknown status

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