Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
NCT ID: NCT04805411
Last Updated: 2022-04-15
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
120 participants
INTERVENTIONAL
2021-02-24
2021-11-08
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
QUADRUPLE
Study Groups
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High-dose arm
600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC
CM310
IL-4Rα monoclonal antibody
low-dose arm
300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC
CM310
IL-4Rα monoclonal antibody
placebo
placebo for 1-8 doses, every 2 weeks, SC
Placebo
Placebo
Interventions
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CM310
IL-4Rα monoclonal antibody
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Inadequate response to topical medications.
Exclusion Criteria
* Concurrent disease/status which may potentially affect the efficacy/safety judgement.
* Organ dysfunction.
* pregnancy.
* Other.
18 Years
70 Years
ALL
No
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital，Capital Medical University
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Chongqing Traditional Chinese Hospital
Chongqing, Chongqing Municipality, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, China
Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Wuxi Second Hospital
Wuxi, Jiangsu, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China
First Hospital of Jilin University
Changchun, Jilin, China
Second Hospital of Jilin University
Changchun, Jilin, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Shandong Provincial Hospital of Dermatology
Jinan, Shandong, China
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
Tianjin, Tianjin Municipality, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Ningbo Second Hospital
Ningbo, Zhejiang, China
Countries
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Other Identifiers
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CM310AD002
Identifier Type: -
Identifier Source: org_study_id
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