A Clinical Study of AK120 in Adolescents With Moderate-to-severe Atopic Dermatitis
NCT ID: NCT06767540
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
198 participants
INTERVENTIONAL
2025-01-23
2027-07-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AK120 600mg every two weeks (Q2W) subcutaneous injection
AK120 600mg at day 1, then 300mg subcutaneous injection Q2W thereafter until week 46.
Placebo
placebo subcutaneous injection Q2W until week 46.
AK120 600mg every three weeks (Q3W) subcutaneous injection
AK120 600mg at day 1, then 300mg subcutaneous injection Q3W thereafter until week 45.
placebo
placebo subcutaneous injection Q3W until week 45.
Interventions
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Placebo
placebo subcutaneous injection Q2W until week 46.
placebo
placebo subcutaneous injection Q3W until week 45.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
12 Years
18 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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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
Liuzhou, 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
Countries
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Central Contacts
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Other Identifiers
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AK120-302
Identifier Type: -
Identifier Source: org_study_id
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