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

NCT ID: NCT07276620

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2029-01-30

Brief 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.

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Ivarmacitinib Sulfate Tablets

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Chen Xiang Xiang Chen

Role: CONTACT

chenxiangck@126.com

073189753406

Su Juan Juan Su

Role: CONTACT

sujuanderm@csu.edu.cn

073189753406

Other Identifiers

MA-DER-RWS-101

Identifier Type: -

Identifier Source: org_study_id