ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
A Randomized, Double-blind, Placebo-controlled Phase III Study Evaluating the Efficacy and Safety of Oral ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
1 other identifier
interventional
552
1 country
62
Brief Summary
A randomized, double-blind, placebo-controlled phase III study evaluating the efficacy and safety of oral ICP-332 in 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_3
Started Nov 2024
62 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
Study Start
First participant enrolled
November 14, 2024
CompletedFirst Submitted
Initial submission to the registry
December 25, 2024
CompletedFirst Posted
Study publicly available on registry
January 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 25, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 25, 2026
September 8, 2025
January 1, 2025
2 years
December 25, 2024
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline
16 weeks
Proportion of subjects achieving Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 with at least two grades of reduction from Baseline
16 weeks
Study Arms (2)
ICP-332
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female subjects between 18 and 75 years of age.
- Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year
- Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable.
- Subjects must meet the following criteria for disease activity:
- Eczema Area and Severity Index (EASI) score ≥ 16 ;
- (Body Surface Area )BSA affected by AD ≥ 10% ;
- (validated Investigator's Global Assessment-AD)vIGA-AD score ≥3 ;
- Baseline weekly average of daily Worst Pruritus NRS ≥ 4.
- Women of childbearing potential (WOCBP) and Men must agree
- \. Women of childbearing potential (WOCBP) and Men must agree to contraception. 6. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
You may not qualify if:
- Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD.
- Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions.
- Pregnant or breastfeeding females.
- History of any clinically major diseases, with the exception of atopic dermatitis.
- Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (62)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230022, China
The Second Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241000, China
Capital Medical University Affiliated Beijing Chaoyang Hospital
Beijing, Beijing Municipality, 100020, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Capital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016, China
Chongqing Traditional Chinese Medicine Hospital
Chongqing, Chongqing Municipality, 400021, China
The Affiliated Union Hospital of Fujian Medical University
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, 361021, China
Dermatology Hospital of Southern Medical University
Guangzhou, Guangdong, 510091, China
Zhongshan University Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510120, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Yuebei People's Hospital
Shaoguan, Guangdong, 512026, China
Shenzhen Second People's Hospital
Shenzhen, Guangdong, 518035, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Affiliated Hospital of Chengde Medical University
Chengde, Hebei, 067000, China
Affiliated Hospital of Hebei University of Engineering
Handan, Hebei, 056002, China
Second Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
Sanmenxia Central Hospital
Sanmenxia, Henan, 472000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Jingzhou Central Hospital
Jingzhou, Hubei, 434020, China
Wuhan Central Hospital
Wuhan, Hubei, 430014, China
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital)
Wuhan, Hubei, 430022, China
Central South University Xiangya Hospital
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010050, China
Changzhou First People's Hospital
Changzhou, Jiangsu, 213003, China
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, 211166, China
Yancheng First People's Hospital
Yancheng, Jiangsu, 224001, China
The First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
Affiliated Hospital of Jiujiang University
Jiujiang, Jiangxi, 332000, China
Jiangxi Provincial Dermatology Hospital
Nanchang, Jiangxi, 330001, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine （Shenyang Seventh People's Hospital）
Shenyang, Liaoning, 110001, China
Zhongyi Northeast International Hospital Co., Ltd.
Shenyang, Liaoning, 110179, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 710068, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Shandong Provincial Dermatosis Hospital
Jinan, Shandong, 250022, China
Jining First People's Hospital
Jining, Shandong, 272011, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266003, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 440000, China
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
General Hospital of Tianjin Medical University
Tianjin, Tianjin Municipality, 300052, China
Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300120, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310006, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The Third People's Hospital of Hangzhou
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The Fourth Affiliated Hospital, Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2024
First Posted
January 15, 2025
Study Start
November 14, 2024
Primary Completion (Estimated)
November 25, 2026
Study Completion (Estimated)
December 25, 2026
Last Updated
September 8, 2025
Record last verified: 2025-01