A Study to Evaluate the Safety and Efficacy of AK120 in Subjects With Moderate to Severe Atopic Dermatitis
NCT ID: NCT06092762
Last Updated: 2024-11-25
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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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2023-11-06
2024-11-13
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
NONE
Study Groups
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AK120 300mg
AK120 loading dose 600mg, then 300mg subcutaneous injection every 2 weeks thereafter until week 14.
AK120
subcutaneous injection every 2 weeks
AK120 450mg
AK120 loading dose 600mg, then 450mg subcutaneous injection every 2 weeks thereafter until week 14.
AK120
subcutaneous injection every 2 weeks
Interventions
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AK120
subcutaneous injection every 2 weeks
Eligibility Criteria
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Inclusion Criteria
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 with a history of an inadequate response or medically inappropriate use of topical drug treatment within 6 months
Exclusion Criteria
2. Received systemic traditional Chinese medicine treatment within the 4 weeks before randomization or topical traditional Chinese medicine treatment within 1 week before randomization
3. Received treatment with other clinical study drugs within 1 month or 5 half-lives before randomization (whichever is longer)
4. Received or planned to receive live vaccine treatment within the 3 months before randomization or during the study period.
5. Received allergen specific immunotherapy within the 3 months before randomization.
6. Have a history of allergies to any component of AK120 and/or severe allergic reactions to monoclonal antibodies.
18 Years
75 Years
ALL
No
Sponsors
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Akeso
INDUSTRY
Responsible Party
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Locations
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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
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Air Force Medical Center
Beijing, Beijing Municipality, 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
Countries
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Other Identifiers
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AK120-206
Identifier Type: -
Identifier Source: org_study_id
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