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
1 other identifier
interventional
450
1 country
50
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2024
Shorter than P25 for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 8, 2024
CompletedFirst Submitted
Initial submission to the registry
November 14, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2025
CompletedMarch 17, 2026
March 1, 2026
1.1 years
November 14, 2024
March 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Eczema Area and Severity Index (EASI) score
baseline to week 20
Investigator's Global Assessment (IGA) 0/1
from baseline to week 20
Affected body surface area (BSA) score
from baseline to week 20
Area under the curve(AUC) of AK120
before drug administration at week 0/4/8/12/16
Anti-drug antibodies (ADA) of AK120
before drug administration at week 0/4/8/16/20
Study Arms (1)
AK120 300mg Q2W(Double the initial dose)
EXPERIMENTALAK120 600mg (first day) then 300mg Q2W SC until week 14.
Interventions
AK120 300mg Q2W SC until week 14(JAK inhibitor users need to receive a first dose of 600mg SC)
Eligibility Criteria
You may qualify if:
- 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 who are suitable for continue using biological treatment assessed by investigator
You may not qualify if:
- Acute onset of AD within 4 weeks before drug administration.
- The accompany disease have been assessed by the investigators during screening period as unsuitable for participation in this study.
- 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
- Have a known or suspected history of immunosuppressive diseases, including a history of invasive infections.
- Having undergone or planned major surgery within 4 weeks prior to drug administration, or unable to fully recover from surgery prior to drug administration.
- any medical or psychological condition that puts subjects at risk or may affect the study results assessed by investigators.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
Study Sites (50)
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Xiyuan Hospital of CACMS
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
The Second Hospital & Clinical Medical School, Lanzhou University
Lanzhou, Gansu, China
Guangdong Provincial Dermatology Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Second people's Hospital of Shenzhen
Shenzhen, Guangdong, China
Shenzhen Hospital of University of Hong Kong
Shenzhen, Guangdong, China
Liuzhou People's Hospital
Liuchow, Guangxi, China
Cangzhou People's Hospital
Cangzhou, Hebei, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, China
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
People Hospital of Xingtai
Xingtai, Hebei, China
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Anyang District Hospital
Anyang, Henan, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Jingzhou Central Hospital
Jingzhou, Hubei, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Wuhan No.1 Hospital
Wuhan, Hubei, China
Changde First People's Hospital
Changde, Hunan, China
XiangYa Hospital CentralSouth University
Changsha, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
The Affiliated Hospital of Inner Mongolia Medical College
Hohhot, Inner Mongolia, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
The Affiliated Hospital of Yanbian University Yanbian Hospital
Yanbian, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong First Medical University Affiliated Dermatology Hospital
Jinan, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Shanghai Yueyang Integrated Traditional Chinese Medicine and Western Medicine Hospital
Shanghai, Shanghai Municipality, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uygur Municipal People's Hospital
Ürümqi, Xinjiang, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Qujing No.1 Hospital
Qujing, Yunnan, China
Affiliated Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Hangzhou Third People's Hospital
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Jiaxing Second Hospital
Jiaxing, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
Taizhou Central Hospital
Taizhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2024
First Posted
November 22, 2024
Study Start
July 8, 2024
Primary Completion
July 31, 2025
Study Completion
September 11, 2025
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share