Treatment of Moderate-to-Severe Atopic Dermatitis With Ivarmacitinib in Adolescents and Adults

Central South University

Status

Not yet enrolling

Conditions

Atopic Dermatitis (AD)

Treatments

Drug: Ivarmacitinib Sulfate Tablets

Study type

Interventional

Funder types

Other

Identifiers

NCT07276620

MA-DER-RWS-101

Details and patient eligibility

About

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.

Enrollment

1,000 estimated patients

Sex

All

Ages

12 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged between 12 and 75 years;
Diagnosed with moderate-to-severe atopic dermatitis (AD) ;
Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.

Exclusion criteria

Subject has any of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat, if deemed necessary:
1. Absolute lymphocyte count of <0.50 x 10^9 /L (<500/mm3);
2. Absolute Neutrophil Count (ANC) of <1 X 10^9/L (<1000/mm3);
3. Hemoglobin level < 80 g/L.
Subject has any malignancies or has a history of malignancies with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ.
Subject with a prior history of thromboembolic events, including deep vein thromboses (DVT), pulmonary embolism, cerebrovascular accidents and those with known inherited conditions that predispose to hypercoagulability.
Presence of an active severe acute or chronic bacterial, fungal, or viral infection requiring systemic therapy.
Subjects with active tuberculosis or known active hepatitis B and/or hepatitis C infection.
Subjects with clinically significant diseases of the heart, liver, kidney, or other major organ systems.
Female subject who is pregnant, breastfeeding, or considering pregnancy during the study.