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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: AK120 300mg Q2W (JAK inhibitor users need to double the initial dose)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China
      • Beijing Luhe Hospital Affiliated to Capital Medical University
    • Beijing, Beijing Municipality, China
      • Xiyuan Hospital of CACMS
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
    • Xiamen, Fujian, China
      • The Second Affiliated Hospital of Xiamen Medical College
  • Gansu
    • Lanzhou, Gansu, China
      • The Second Hospital & Clinical Medical School, Lanzhou University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China
      • Guangdong Provincial Dermatology Hospital
    • Shenzhen, Guangdong, China
      • Second people's Hospital of Shenzhen
    • Shenzhen, Guangdong, China
      • Shenzhen Hospital of University of Hong Kong
  • Guangxi
    • Liuchow, Guangxi, China
      • Liuzhou People's Hospital
  • Hebei
    • Cangzhou, Hebei, China
      • Cangzhou People's Hospital
    • Chengde, Hebei, China
      • Affiliated Hospital of Chengde Medical University
    • Shijiazhuang, Hebei, China
      • The First Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • Shijiazhuang Hospital of Traditional Chinese Medicine
    • Xingtai, Hebei, China
      • The Second Affiliated Hospital of Xingtai Medical College
    • Xingtai, Hebei, China
      • People Hospital of Xingtai
  • Henan
    • Anyang, Henan, China
      • Anyang District Hospital
    • Luoyang, Henan, China
      • The Second Affiliated Hospital of Henan University of Science and Technology
    • Sanmenxia, Henan, China
      • Sanmenxia Central Hospital
  • Hubei
    • Jingzhou, Hubei, China
      • Jingzhou Central Hospital
    • Wuhan, Hubei, China
      • Wuhan No.1 Hospital
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University
  • Hunan
    • Changde, Hunan, China
      • Changde First People's Hospital
    • Changsha, Hunan, China
      • XiangYa Hospital CentralSouth University
    • Yueyang, Hunan, China
      • Yueyang Central Hospital
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • The Affiliated Hospital of Inner Mongolia Medical College
  • Jiangsu
    • Nantong, Jiangsu, China
      • Affiliated Hospital of Nantong University
    • Wuxi, Jiangsu, China
      • Wuxi People's Hospital
    • Zhenjiang, Jiangsu, China
      • Affiliated Hospital of Jiangsu University
  • Jilin
    • Yanbian, Jilin, China
      • The Affiliated Hospital of Yanbian University Yanbian Hospital
  • Shandong
    • Jinan, Shandong, China
      • Qilu Hospital of Shandong University
    • Jinan, Shandong, China
      • Shandong First Medical University Affiliated Dermatology Hospital
    • Yantai, Shandong, China
      • Yantai Yuhuangding Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Skin Disease Hospital
    • Shanghai, Shanghai Municipality, China
      • Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • Taiyuan Central Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China
      • The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
    • Tianjin, Tianjin Municipality, China
      • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Xinjiang Uygur Municipal People's Hospital
  • Yunnan
    • Kunming, Yunnan, China
      • The First Affiliated Hospital of Kunming Medical University
    • Qujing, Yunnan, China
      • Qujing NO.1 Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • Affiliated Hangzhou First People's Hospital
    • Hangzhou, Zhejiang, China
      • Hangzhou Third People's Hospital
    • Jiaxing, Zhejiang, China
      • The First hospital of Jiaxing
    • Jiaxing, Zhejiang, China
      • Jiaxing Second Hospital
    • Ningbo, Zhejiang, China
      • Ningbo No.2 Hospital
    • Taizhou, Zhejiang, China
      • Taizhou Central Hospital

Participation Criteria

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 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 by investigator

Exclusion Criteria:

1. Acute onset of AD within 4 weeks before drug administration.
2. The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
3. Any history or symptoms of malignant tumors in any organ within 5 years prior to screening, regardless of whether treatment has been received and whether there are signs of recurrence or metastasis
4. Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
5. Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
6. any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AK120 300mg Q2W(Double the initial dose); AK120 600mg (first day) then 300mg Q2W SC until week 14.	Drug: AK120 300mg Q2W (JAK inhibitor users need to double the initial dose); AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment emergent adverse events (TEAEs)	An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment	through study completion, an average of 25 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eczema Area and Severity Index (EASI) score	Percentage change in EASI score from baseline. EASI score is to assesses the extent and severity of eczema in four body regions with the score ranges from 0 to 72. The higher the score, the more severe the eczema.	baseline to week 20
Investigator's Global Assessment (IGA) 0/1	Percentage of subjects who achieved 0/1 in the IGA. The IGA is an assessment instrument used in clinical studies to rate the severity of atopic dermatitis globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).	from baseline to week 20
Affected body surface area (BSA) score	Percentage change in BSA score from baseline. Body surface area affected by atopic dermatitis will be assessed for each section of the body (0-100%) and will be reported as a percentage of all major body sections combined.	from baseline to week 20
Area under the curve(AUC) of AK120	Assessment of AUC of AK120.	before drug administration at week 0/4/8/12/16
Anti-drug antibodies (ADA) of AK120	Percentage of subjects with detectable anti drug antibodies (ADA) of AK120.	before drug administration at week 0/4/8/16/20

Collaborators and Investigators

• Sponsor: Akeso

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): September 11, 2025

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Janus Kinase Inhibitors
• Other Study ID Numbers: AK120-207

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