RecruitingPhase 3NCT06775860
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
Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment
552 participants
Start Date
Nov 14, 2024
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria10
- 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.
Exclusion Criteria5
- 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.
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Interventions
DRUGICP-332 Tablets
ICP-332 will be administered as tablet
DRUGICP-332 Placebo Tablets
ICP-332 Placebo will be administered as tablet
Locations(62)
View Full Details on ClinicalTrials.gov
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NCT06775860
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