ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

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

Key facts

Study ID

NCT06775860

Run by

Beijing InnoCare Pharma Tech Co., Ltd.

People needed

552

Starts

2024-11-14

Expected to finish

2026-12-25

Last updated by the study team

2025-09-08

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• The Second Affiliated Hospital of Wannan Medical College — Wuhu, Anhui, China (enrolling)
• Capital Medical University Affiliated Beijing Chaoyang Hospital — Beijing, Beijing Municipality, China (enrolling)
• Peking University First Hospital — Beijing, Beijing Municipality, China (enrolling)
• Capital Medical University Affiliated Beijing Friendship Hospital — Beijing, Beijing Municipality, China (enrolling)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
• Beijing Tongren Hospital, Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (enrolling)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (enrolling)
• Chongqing Traditional Chinese Medicine Hospital — Chongqing, Chongqing Municipality, China (enrolling)
• The Affiliated Union Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
• The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
• The Second Affiliated Hospital of Xiamen Medical College — Xiamen, Fujian, China (enrolling)
• Dermatology Hospital of Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Zhongshan University Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (enrolling)
• Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (enrolling)
• Yuebei People's Hospital — Shaoguan, Guangdong, China (enrolling)
• Shenzhen Second People's Hospital — Shenzhen, Guangdong, China (enrolling)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (enrolling)
• Affiliated Hospital of Chengde Medical University — Chengde, Hebei, China (enrolling)
• Affiliated Hospital of Hebei University of Engineering — Handan, Hebei, China (enrolling)
• Second Affiliated Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• The Second Affiliated Hospital of Henan University of Science and Technology — Luoyang, Henan, China (enrolling)
• Sanmenxia Central Hospital — Sanmenxia, Henan, China (enrolling)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (enrolling)

Full record on ClinicalTrials.gov

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