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

Last updated: March 2, 2025
Sponsor: Akeso
Overall Status: Completed

Phase

1/2

Condition

Rash

Allergies & Asthma

Eczema (Atopic Dermatitis - Pediatric)

Treatment

AK120

Placebo

Clinical Study ID

NCT06035354
AK120-102
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female with age 18 - 75 years (inclusive).

  2. Atopic dermatitis (AD) diagnosed at least half an year before screening.

  3. Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline.

  4. Subjects with a history of an inadequate response or medically inappropriate use oftopical drug treatment within 6 months.

Exclusion

Exclusion Criteria:

  1. Suffering from other inflammatory diseases that may affect efficacy outcomes (suchas rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease,scleroderma, inflammatory myopathy, mixed connective tissue disease, overlapsyndrome, etc.).

  2. History of exposure to active TB, and/or history or current evidence of TBinfection.

  3. Positive serology results at Screening for hepatitis B, hepatitis C or HIV.

  4. Any history of vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC) within 6 months before the baseline visit.

  5. History of clinical parasite infection, recent or planned travel to an area withendemic parasite infection within 6 months before the Screening visit

  6. Any medical or psychiatric condition, laboratory, or ECG parameter which, in theopinion of the Investigator or the Sponsor's medical monitor, would place thesubject at risk, interfere with participation in the study, or interfere with theinterpretation of study results.

Study Design

Total Participants: 427
Treatment Group(s): 2
Primary Treatment: AK120
Phase: 1/2
Study Start date:
November 03, 2021
Estimated Completion Date:
June 21, 2024

Study Description

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.

Connect with a study center

  • AkesoBio Investigative Site 2037, The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui
    China

    Site Not Available

  • AkesoBio Investigative Site 2036, The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui
    China

    Site Not Available

  • AkesoBio Investigative Site 1001, Peking University People's Hospital

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 2044, Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing
    China

    Site Not Available

  • AkesoBio Investigative Site 2023, Xinqiao Hospital Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • AkesoBio Investigative Site 2024, Chongqing Three Gorges Medical College

    Chongqing, Chongqing
    China

    Site Not Available

  • AkesoBio Investigative Site 2040, Chongqing Traditional Chinese Medicine Hospital

    Chongqing, Chongqing
    China

    Site Not Available

  • AkesoBio Investigative Site 2052, The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Site Not Available

  • AkesoBio Investigative Site 2038, The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Site Not Available

  • AkesoBio Investigative Site 2022, Dongguan People's Hospital

    Dongguan, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 1002, Guangdong Provincial People's Hospital

    Guangzhou, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 2003, Dermatology Hospital of Southern Medical University

    Guangzhou, Guangdong
    China

    Site Not Available

  • AkesoBio Investigative Site 2049, The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou
    China

    Site Not Available

  • AkesoBio Investigative Site 2004, The First Affiliated Hospital of Hainan Medical University

    Haikou, Hainan
    China

    Site Not Available

  • AkesoBio Investigative Site 2001, Affiliated Hospital of Chengde medical university

    Chengde, Hebei
    China

    Site Not Available

  • AkesoBio Investigative Site 2010, Nanyang First People's Hospital National Third Class A Hospital

    Nanyang, Henan
    China

    Site Not Available

  • AkesoBio Investigative Site 2051, Jingzhou Central Hospital

    Jingzhou, Hubei
    China

    Site Not Available

  • AkesoBio Investigative Site 1005, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei
    China

    Site Not Available

  • AkesoBio Investigative Site 2046, The Third Xiangya Hospital of Central South University

    Changsha, Hunan
    China

    Site Not Available

  • AkesoBio Investigative Site 2008, The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia
    China

    Site Not Available

  • AkesoBio Investigative Site 2048, The First People's Hospital of Changzhou

    Changzhou, Jiangsu
    China

    Site Not Available

  • AkesoBio Investigative Site 2050, Wuxi Second People's Hospital

    Wuxi, Jiangsu
    China

    Site Not Available

  • AkesoBio Investigative Site 2025, Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu
    China

    Site Not Available

  • AkesoBio Investigative Site 2032, The First Affiliated Hospital of Gannan Medical College

    Ganzhou, Jiangxi
    China

    Site Not Available

  • AkesoBio Investigative Site 2011, Northeast International Hospital

    Shenyang, Liaoning
    China

    Site Not Available

  • AkesoBio Investigative Site 2039, Shandong Provincial Dermatology Hospital

    Jinan, Shandong
    China

    Site Not Available

  • AkesoBio Investigative Site 2041, Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Site Not Available

  • AkesoBio Investigative Site 1003, Shanghai Skin Disease Hospital

    Shanghai, Shanghai
    China

    Site Not Available

  • AkesoBio Investigative Site 2027, Medical School of Yanan University

    Xianyang, Shanxi
    China

    Site Not Available

  • AkesoBio Investigative Site 2029, West China Hospital,Sichuan University

    Chengdu, Sichuan
    China

    Site Not Available

  • AkesoBio Investigative Site 2034, Chengdu Second People's Hospital

    Chengdu, Sichuan
    China

    Site Not Available

  • AkesoBio Investigative Site 2013, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • AkesoBio Investigative Site 2019, Tianjin Medical University General Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • AkesoBio Investigative Site 2043, First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Site Not Available

  • AkesoBio Investigative Site 1004, Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • AkesoBio Investigative Site 2006,Affiliated Hangzhou First People's Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • AkesoBio Investigative Site 2007, Hangzhou Third People's Hospital

    Hangzhou, Zhejiang
    China

    Site Not Available

  • AkesoBio Investigative Site 2035, The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • AkesoBio Investigative Site 2009, The First Hospital of Jiaxing

    Jiaxing, Zhejiang
    China

    Site Not Available

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