A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
a Multicenter, Randomized, Open Label Phase II Clinical Study to Evaluate the Safety and Efficacy of AK120 in the Treatment of Subjects With Moderate to Severe Atopic Dermatitis
1 other identifier
interventional
180
1 country
26
Brief Summary
This is a multicenter, randomized, open label phase II clinical study to evaluate the safety and efficacy 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 Nov 2023
Shorter than P25 for phase_2
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedStudy Start
First participant enrolled
November 6, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 13, 2024
CompletedNovember 25, 2024
November 1, 2024
1 year
October 16, 2023
November 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of adverse events(AE)
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
week 0 to week 24
Secondary Outcomes (6)
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-75
at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved (Eczema Area and Severity Index) EASI-50
at week 2/4/8/12/16 /20 and 24
Percentage change in (Eczema Area and Severity Index) EASI scores from baseline
at week 2/4/8/12/16 /20 and 24
Percentage of subjects who achieved 0/1 in the (Investigator's Global Assessment) IGA
at week 2/4/8/12/16 /20 and 24
Percentage of subjects with a (Investigator's Global Assessment) IGA score decrease of ≥ 2 points from baseline
at week 2/4/8/12/16 /20 and 24
- +1 more secondary outcomes
Study Arms (2)
AK120 300mg
EXPERIMENTALAK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14.
AK120 450mg
EXPERIMENTALAK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14.
Interventions
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 with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months
You may not qualify if:
- Received systemic corticosteroids, immunosuppressive/immunomodulatory drugs, phototherapy within the 4 weeks before randomization.
- Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization
- Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer)
- Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
- Received allergen specific immunotherapy within the 3 months before randomization.
- Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Akesolead
Study Sites (26)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Air Force Medical Center
Beijing, Beijing Municipality, China
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
People Hospital of Xingtai
Xingtai, Hebei, China
Renmin Hospital of Wuhan University Hubei General Hospital
Wuhan, Hubei, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Yancheng No.1 People's Hospital
Yancheng, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
Qingdao Municipal Hospital
Qingdao, Shandong, China
Baoji Central Hospital
Baoji, Shanxi, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo No.2 Hospital
Ningbo, Zhejiang, China
The first affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Yiwu, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2023
First Posted
October 23, 2023
Study Start
November 6, 2023
Primary Completion
November 13, 2024
Study Completion
November 13, 2024
Last Updated
November 25, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share