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Treatment of Moderate-to-Severe Atopic Dermatitis With Ivarmacitinib in Adolescents and Adults
Sponsor: Xiangya Hospital of Central South University
Summary
Atopic dermatitis (AD) is a skin condition characterized by a rash and itching, resulting from skin inflammation. Ivarmacitinib is an approved medication for treating AD. This study aims to evaluate the effectiveness and safety of Ivarmacitinib in the treatment of moderate-to-severe atopic dermatitis under real-world conditions. It will assess the time to pruritus improvement and skin lesion clearance, collect large-sample safety data, analyze disease improvement across patient subgroups with different baseline characteristics, and explore the impact of various maintenance treatment regimens on disease recurrence. It is expected that there will be no additional burden for participants in this trial.
Official title: A Study on the Efficacy and Safety of Ivarmacitinib in the Treatment of Moderate to Severe Atopic Dermatitis in Adolescents and Adults
Key Details
Gender
All
Age Range
12 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2025-11-30
Completion Date
2029-01-30
Last Updated
2025-12-11
Healthy Volunteers
No
Conditions
Interventions
Ivarmacitinib Sulfate Tablets
Patients with moderate to severe atopic dermatitis are initially treated with 4 mg of ivarmacitinib once daily for 16 weeks. Subsequently, those who respond adequately may transition to an individualized maintenance regimen until week 52.If a suboptimal response is observed with the 4 mg once-daily dose, an increase to 8 mg once daily may be considered. Treatment should be discontinued if an adequate response is not achieved following dose escalation to 8 mg once daily.