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

April 21, 2024 updated by: Akeso

a Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of AK120 in the Treatment of Patients With Moderate to Severe Atopic Dermatitis

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 injection in the treatment of patients with moderate to severe atopic dermatitis. The entire study included a screening period, a double-blind controlled treatment period, a conversion and maintenance treatment period, and a safe follow-up period.

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Peking University People's Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Peking University Third Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Tongren Hospital
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Friendship Hospital Capital Medical University
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Luhe Hospital Affiliated to Capital Medical University
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing Traditional Chinese Medicine Hospital
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing Three Gorges Medical College affiliated People's Hospital
    • Fujian
      • Fuzhou, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
      • Xiamen, Fujian, China
        • Recruiting
        • The Second Affiliated Hospital of Xiamen Medical College
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
      • Guangzhou, Guangdong, China
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Guangzhou, Guangdong, China
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China
        • Recruiting
        • Southern Medical University Dermatology Hospital/Guangdong Provincial Dermatology Hospital
      • Guangzhou, Guangdong, China
        • Recruiting
        • Southern Medical University Southern Hospital
      • Shaoguan, Guangdong, China
        • Recruiting
        • Yuebei People's hospital, Guangdong, China
      • Shunde, Guangdong, China
        • Recruiting
        • Shunde Hospital of Southern Medical University
      • Zhanjiang, Guangdong, China
        • Recruiting
        • Guangdong Medical University Affiliated Hospital
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
    • Hainan
      • Haikou, Hainan, China
        • Recruiting
        • Hainan General Hospital
      • Haikou, Hainan, China
        • Recruiting
        • The First Affiliated Hospital Of Hainan Medical College
      • Haikou, Hainan, China
        • Recruiting
        • Hainan Provincial Fifth People's Hospital
    • Hebei
      • Chengde, Hebei, China
        • Recruiting
        • Chengde Medical College Affiliated Hospital
      • Xingtai, Hebei, China
        • Recruiting
        • The Second Affiliated Hospital of Xingtai Medical College
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • Heilongjiang Provincial Hospital
      • Harbin, Heilongjiang, China
        • Recruiting
        • Harbin Medical University Affiliated Second Hospital
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • The Second Affiliated Hospital of Henan University of Science and Technology
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital
      • Wuhan, Hubei, China
        • Recruiting
        • Renmin Hospital of Wuhan University Hubei General Hospital
    • Hunan
      • Changde, Hunan, China
        • Recruiting
        • Changde First People's Hospital
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital of Central South University
      • Hengyang, Hunan, China
        • Recruiting
        • The First Affiliated Hospital of South China University
    • Inner Mongolia
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Inner Mongolia Medical University Affiliated Hospital
    • Jiangsu
      • Bengbu, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
      • Changzhou, Jiangsu, China
        • Recruiting
        • Changzhou First People's Hospital
      • Yancheng, Jiangsu, China
        • Recruiting
        • Yancheng First People's Hospital
      • Zhenjiang, Jiangsu, China
        • Recruiting
        • Jiangsu University Affiliated Hospital
    • Jiangxi
      • Ganzhou, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of Gannan Medical College
    • Jilin
      • Changchun, Jilin, China
        • Recruiting
        • The First Bethune Hospital of Jilin University
    • Liaoning
      • Panjin, Liaoning, China
        • Recruiting
        • Panjin Liaoyou Gemstone Flower Hospital
      • Shenyang, Liaoning, China
        • Recruiting
        • Shenyang Integrated Traditional Chinese and Western Medicine Hospital
      • Shenyang, Liaoning, China
        • Recruiting
        • Zhongyi Northeast International Hospital
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • General Hospital of Ningxia Medical University
    • Shandong
      • Jinan, Shandong, China
        • Recruiting
        • Shandong Provincial Dermatology Hospital
      • Jinan, Shandong, China
        • Recruiting
        • Shandong University Qilu Hospital
      • Qingdao, Shandong, China
        • Recruiting
        • Qingdao Municipal Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Dermatology Hospital
    • Shanxi
      • Baoji, Shanxi, China
        • Recruiting
        • Baoji Central Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan Provincial People's Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Recruiting
        • Xinjiang Uygur Autonomous Region People's Hospital
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou First People's Hospital
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou Third People's Hospital
      • Jiaxing, Zhejiang, China
        • Recruiting
        • Jiaxing First People's Hospital
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo First Hospital
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Huamei Hospital, University of Chinese Academy of Sciences
      • Wenzhou, Zhejiang, China
        • Recruiting
        • Wenzhou Medical University First Affiliated Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female subjects aged ≥18≤75 years old.
  2. Atopic dermatitis (AD) diagnosed at least 1 year before screening.
  3. Subject with eczema area and severity index (EASI) score ≥16, Investigator Global Assessment (IGA) score≥ 3, Body Surface Area (BSA) score ≥ 10% at screening and baseline.
  4. Previously received at least 4 weeks of moderate to strong or at least 2 weeks of strong local glucocorticoid (TCS) treatment for AD before screening, with poor efficacy or intolerable

Exclusion Criteria:

  1. Acute onset of AD within the first 4 weeks of randomization.
  2. Have participated in any clinical research on AK120 in the past
  3. Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
  4. Received treatment with other clinical research drugs (non-biological agents) within the first 4 weeks or 5 half-lives of randomization (whichever is longer)
  5. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
  6. Received allergen specific immunotherapy within the 3 months before randomization.
  7. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AK120 600mg/300mg
AK120 600mg(first day) then 300mg Q2W subcutaneous injection thereafter until week 50.
Drug: AK120
300mg Q2W subcutaneous injection thereafter until week 50.
Placebo Comparator: Placebo/AK120 600mg to 300mg
placebo Q2W SC, then AK120 600mg at week 16, thereafter change to AK120 300mg Q2W subcutaneous injection until week 50.
Drug: AK120
300mg Q2W subcutaneous injection thereafter until week 50.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
Time Frame: at week 16
Percentage of patients in both treatment group and placebo group who achieved EASI 75 at week 16.
at week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
Time Frame: at week 16
The percentage of patients in both treatment group and placebo group who achieved IGA 0/1 score at week 16.
at week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akeso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 30, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 30, 2026

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

April 21, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK120-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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