ICP-332 in Subjects with Moderate to Severe Atopic Dermatitis

Launched by BEIJING INNOCARE PHARMA TECH CO., LTD. · Jan 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new oral medication called ICP-332 to see how well it works for people with moderate to severe atopic dermatitis, which is also known as eczema. The study is in its final phase and is looking for participants aged 18 to 75 who have been diagnosed with chronic atopic dermatitis for at least a year. To qualify, participants need to have tried other treatments that didn't work well for them and meet specific criteria related to the severity of their skin condition.

Participants in this trial can expect to take the medication or a placebo (a non-active pill) and will be closely monitored through scheduled visits and tests. The goal is to find out if ICP-332 can provide relief from the symptoms of atopic dermatitis, like itching and skin irritation. It's important to note that women who can become pregnant and men must agree to use contraception during the study. If you or someone you know has struggled with atopic dermatitis and meets the eligibility criteria, this trial could offer a potential new treatment option.

Gender

ALL

Eligibility criteria

• 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.