Atopic Dermatitis
Conditions
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
Interventions
DRUGICP-332 Tablets
ICP-332 will be administered as tablet
ICP-332 Placebo will be administered as tablet
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactPengcheng Lei
Outcome results
None listed