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

Last updated: November 21, 2024
Sponsor: Akeso
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatitis, Atopic

Rosacea

Allergies & Asthma

Treatment

AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)

Clinical Study ID

NCT06700499
AK120-207
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female subjects aged ≥18≤75 years old.

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

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

  4. Subjects who are suitable for continue using biological treatment assessed byinvestigator

Exclusion

Exclusion Criteria:

  1. Acute onset of AD within 4 weeks before drug administration.

  2. The accompany disease have been assessed by the investigators during screeningperiod as unsuitable for participation in this study.

  3. Any history or symptoms of malignant tumors in any organ within 5 years prior toscreening, regardless of whether treatment has been received and whether there aresigns of recurrence or metastasis

  4. Have a known or suspected history of immunosuppressive diseases, including a historyof invasive infections.

  5. Having undergone or planned major surgery within 4 weeks prior to drugadministration, or unable to fully recover from surgery prior to drugadministration.

  6. any medical or psychological condition that puts subjects at risk or may affect thestudy results assessed by investigators.

Study Design

Total Participants: 450
Treatment Group(s): 1
Primary Treatment: AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)
Phase: 2
Study Start date:
July 08, 2024
Estimated Completion Date:
November 17, 2025

Study Description

This is a multicenter, open label phase II clinical study to evaluate the efficacy and safety of AK120 in the treatment of subjects with moderate to severe atopic dermatitis. The total duration of the study (including screening period, treatment period and follow-up period) planned for each subject is approximately 25 weeks.

Connect with a study center

  • Beijing Luhe Hospital Affiliated to Capital Medical University

    Beijing, Beijing
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing
    China

    Active - Recruiting

  • Xiyuan Hospital of CACMS

    Beijing, Beijing
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian
    China

    Site Not Available

  • The Second Hospital & Clinical Medical School, Lanzhou University

    Lanzhou, Gansu
    China

    Active - Recruiting

  • Guangdong Provincial Dermatology Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Second people's Hospital of Shenzhen

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Shenzhen Hospital of University of Hong Kong

    Shenzhen, Guangdong
    China

    Active - Recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi
    China

    Active - Recruiting

  • Cangzhou People's Hospital

    Cangzhou, Hebei
    China

    Active - Recruiting

  • Affiliated Hospital of Chengde Medical University

    Chengde, Hebei
    China

    Active - Recruiting

  • Shijiazhuang Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • People Hospital of Xingtai

    Xingtai, Hebei
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xingtai Medical College

    Xingtai, Hebei
    China

    Active - Recruiting

  • Anyang District Hospital

    Anyang, Henan
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan
    China

    Active - Recruiting

  • Sanmenxia Central Hospital

    Sanmenxia, Henan
    China

    Active - Recruiting

  • Jingzhou Central Hospital

    Jingzhou, Hubei
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei
    China

    Active - Recruiting

  • Wuhan No.1 Hospital

    Wuhan, Hubei
    China

    Active - Recruiting

  • Changde First People's Hospital

    Changde, Hunan
    China

    Active - Recruiting

  • XiangYa Hospital CentralSouth University

    Changsha, Hunan
    China

    Active - Recruiting

  • Yueyang Central Hospital

    Yueyang, Hunan
    China

    Active - Recruiting

  • The Affiliated Hospital of Inner Mongolia Medical College

    Hohhot, Inner Mongolia
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu
    China

    Active - Recruiting

  • Wuxi People's Hospital

    Wuxi, Jiangsu
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu
    China

    Active - Recruiting

  • The Affiliated Hospital of Yanbian University Yanbian Hospital

    Yanbian, Jilin
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong
    China

    Active - Recruiting

  • Shandong First Medical University Affiliated Dermatology Hospital

    Jinan, Shandong
    China

    Active - Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong
    China

    Active - Recruiting

  • Shanghai Skin Disease Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Taiyuan Central Hospital

    Taiyuan, Shanxi
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Xinjiang Uygur Municipal People's Hospital

    Urumqi, Xinjiang
    China

    Active - Recruiting

  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan
    China

    Active - Recruiting

  • Qujing No.1 Hospital

    Qujing, Yunnan
    China

    Active - Recruiting

  • Affiliated Hangzhou First People's Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Jiaxing Second Hospital

    Jiaxing, Zhejiang
    China

    Active - Recruiting

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang
    China

    Active - Recruiting

  • Ningbo No.2 Hospital

    Ningbo, Zhejiang
    China

    Active - Recruiting

  • Taizhou Central Hospital

    Taizhou, Zhejiang
    China

    Active - Recruiting

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