A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis
A Randomized Double-blind, Placebo-controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of AK120 in the Treatment of Moderate-to-severe Atopic Dermatitis (AD) in Adolescents
1 other identifier
interventional
198
1 country
28
Brief Summary
This is a randomized double-blind, placebo-controlled, multicenter phase III clinical study evaluating the efficacy and safety of AK120 in the treatment of moderate-to-severe AD in adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2025
28 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
First Submitted
Initial submission to the registry
January 8, 2025
CompletedFirst Posted
Study publicly available on registry
January 10, 2025
CompletedStudy Start
First participant enrolled
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 10, 2027
January 10, 2025
January 1, 2025
2.5 years
January 8, 2025
January 8, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of subjects who achieved Eczema Area and Severity Index (EASI)-75
At week 18, the percentage of subjects who achieved EASI-75 compared to baseline. The EASI score ranges from 0 (no eczema) to 72 (maximum severity).
at week 18 （day 127)
Percentage of subjects with the Investigator's Global Assessment (IGA) score decrease of ≥ 2 points
At week 18, the percentage of subjects with the IGA score decrease of ≥ 2 points from baseline. The IGA is a five-point scale ranging from 0 to 4 ( 0 indicates clear, 4 indicates severe).
at week 18 （day 127)
Secondary Outcomes (4)
Percentage change in affected Body Surface Area (BSA)
week 0 to week 52
percentage change of Peak Pruritus Numerical Rating Scale (P-NRS) scores
week 0 to week 52
Percentage changes in the Children's Dermatology Life Quality Index (CDLQI) score
week 0 to week 52
Incidence of Adverse Events (AE)
week 0 to week 52
Study Arms (2)
AK120 600mg every two weeks (Q2W) subcutaneous injection
EXPERIMENTALAK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46.
AK120 600mg every three weeks (Q3W) subcutaneous injection
EXPERIMENTALAK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45.
Interventions
placebo subcutaneous injection Q2W until week 46.
Eligibility Criteria
You may qualify if:
- Male or female subjects aged ≥12\<18 years old, weight ≥ 30kg.
- AD diagnosed at least half a year before screening.
- Subject with EASI score ≥16, IGA ≥ 3, BSA ≥ 10% at screening and baseline
- Daily peak P-NRS scores (weekly average) at baseline visit ≥ 4.
You may not qualify if:
- Acute onset of AD in 4 weeks prior to enrollment.
- Undergone or planned surgery during the study period within the 4 weeks prior to enrollment, or unable to fully recover from surgery before enrollment.
- Previously suffered from vernal keratoconjunctivitis (VKC) or atopic keratoconjunctivitis (AKC).
- 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 4 weeks or 5 halflives before randomization (whichever is longer).
- 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 (28)
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 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
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
The University of Hong Kong - Shenzhen Hospital
Shenzhen, Guangdong, China
The Third People's Hospital of Zhuhai
Zhuhai, Guangdong, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, China
Jinzhou Central Hospital
Jinzhou, Hubei, China
Tongji Hospital
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
XiangYa Hospital CentralSouth University
Changsha, Hunan, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
Dermatology Hospital of Jiangxi Province
Nanchang, Jiangxi, China
Shandong Provincial Dermatology Hospital
Jinan, Shandong, China
Jining First People's Hospital
Jining, Shandong, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 8, 2025
First Posted
January 10, 2025
Study Start
January 23, 2025
Primary Completion (Estimated)
July 10, 2027
Study Completion (Estimated)
July 10, 2027
Last Updated
January 10, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share