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Recruiting Phase 3

ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis

NCT06775860 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2024-11-14
Last updated
2025-09-08

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

ICP-332 Tablets →ICP-332 Placebo Tablets

ICP-332 Tablets: ICP-332 will be administered as tablet

ICP-332 Placebo Tablets: ICP-332 Placebo will be administered as tablet

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male or female subjects between 18 and 75 years of age. 2. Clinical diagnosis of chronic atopic dermatitis (also known as atopic eczema) for at least 1 year 3. Documented recent history of inadequate response to TCS or TCI, or for whom topical treatments are otherwise medically inadvisable. 4. 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. 5. Women of childbearing potential (WOCBP) and Men must agree 5\. 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. Exclusion Criteria: 1. Lack of response or inadequate response to prior treatment with any JAK inhibitor for AD. 2. Other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of atopic dermatitis lesions. 3. Pregnant or breastfeeding females. 4. History of any clinically major diseases, with the exception of atopic dermatitis. 5. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ICP-332 or participate in this study.

Primary outcome measure(s)

  • 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

Trial sites (62)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei Anhui Recruiting
The Second Affiliated Hospital of Wannan Medical College Wuhu Anhui Recruiting
Capital Medical University Affiliated Beijing Chaoyang Hospital Beijing Beijing Municipality Recruiting
Peking University First Hospital Beijing Beijing Municipality Recruiting
Capital Medical University Affiliated Beijing Friendship Hospital Beijing Beijing Municipality Recruiting
Peking University Third Hospital Beijing Beijing Municipality Recruiting
Beijing Tongren Hospital, Capital Medical University Beijing Beijing Municipality Recruiting
Beijing Tsinghua Changgung Hospital Beijing Beijing Municipality Recruiting
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality Recruiting
Chongqing Traditional Chinese Medicine Hospital Chongqing Chongqing Municipality Recruiting
The Affiliated Union Hospital of Fujian Medical University Fuzhou Fujian Recruiting
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian Recruiting
The Second Affiliated Hospital of Xiamen Medical College Xiamen Fujian Recruiting
Dermatology Hospital of Southern Medical University Guangzhou Guangdong Recruiting
Zhongshan University Sun Yat-sen Memorial Hospital Guangzhou Guangdong Recruiting
Nanfang Hospital, Southern Medical University Guangzhou Guangdong Recruiting
Yuebei People's Hospital Shaoguan Guangdong Recruiting
Shenzhen Second People's Hospital Shenzhen Guangdong Recruiting
Liuzhou People's Hospital Liuzhou Guangxi Recruiting
Affiliated Hospital of Chengde Medical University Chengde Hebei Recruiting
Affiliated Hospital of Hebei University of Engineering Handan Hebei Recruiting
Second Affiliated Hospital of Hebei Medical University Shijiazhuang Hebei Recruiting
The Second Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Recruiting
Sanmenxia Central Hospital Sanmenxia Henan Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Recruiting
Jingzhou Central Hospital Jingzhou Hubei Recruiting
Wuhan Central Hospital Wuhan Hubei Recruiting
Wuhan Hospital of Traditional Chinese and Western Medicine (Wuhan No.1 Hospital) Wuhan Hubei Recruiting
Central South University Xiangya Hospital Changsha Hunan Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Recruiting
The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia Recruiting
Changzhou First People's Hospital Changzhou Jiangsu Recruiting
Sir Run Run Hospital, Nanjing Medical University Nanjing Jiangsu Recruiting
Yancheng First People's Hospital Yancheng Jiangsu Recruiting
The First Affiliated Hospital of Gannan Medical University Ganzhou Jiangxi Recruiting
Affiliated Hospital of Jiujiang University Jiujiang Jiangxi Recruiting
Jiangxi Provincial Dermatology Hospital Nanchang Jiangxi Recruiting
The First Affiliated Hospital of Nanchang University Nanchang Jiangxi Recruiting
The First Hospital of Jilin University Changchun Jilin Recruiting
Shenyang Hospital of Integrated Traditional Chinese and Western Medicine (Shenyang Seventh People's Hospital) Shenyang Liaoning Recruiting

+ 22 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06775860 on ClinicalTrials.gov ↗ ← All trials in China