ICP-332 in Subjects With Moderate to Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ICP-332 Tablets, ICP-332 Placebo Tablets.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- Drug ICP-332 Tablets
ICP-332 will be administered as tablet - Drug ICP-332 Placebo Tablets
ICP-332 Placebo will be administered as tablet
Primary outcome measures
- Proportion of subjects achieving at least a 75% reduction in Eczema Area and Severity Index (EASI 75) from Baseline [Time frame: 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 [Time frame: 16 weeks]
Eligibility criteria
Inclusion criteria
- 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
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 62 centers
- The First Affiliated Hospital of Anhui Medical University — Hefei
- The Second Affiliated Hospital of Wannan Medical College — Wuhu
- Capital Medical University Affiliated Beijing Chaoyang Hospital — Beijing
- Peking University First Hospital — Beijing
- Capital Medical University Affiliated Beijing Friendship Hospital — Beijing
- Peking University Third Hospital — Beijing
- Beijing Tongren Hospital, Capital Medical University — Beijing
- Beijing Tsinghua Changgung Hospital — Beijing
- … and 54 more centers
Identifiers
NCT: NCT06775860 · ICP-CL-00604