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

NCT07276620 | Not Yet Recruiting

• 1 other identifier: MA-DER-RWS-101
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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)

Keywords

Atopic Dermatitis; Ivarmacitinib

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16

  EASI is a tool used to measure the extent (area) and severity of atopic dermatitis based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness , thickness, scratching, and lichenification. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.

  Baseline and Week 16

Secondary Outcomes (7)

• Time to achieve a ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS).

  Baseline and Day 7

• The proportion of patients achieving an Investigator's Global Assessment (IGA) response at each scheduled visit, defined as an IGA score of 0 or 1 with at least a 2-point reduction from baseline.

  Baseline and Week 1、2、4、8、12、16、24、32、40、52

• The proportion of subjects achieving EASI 75 at each scheduled visit.

  Baseline and Week 1、2、4、8、12、24、32、40、52

• Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score

  Baseline and Week 1、2、4、8、12、16、24、32、40、52

• Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI)

  Baseline and Week 1、2、4、8、12、16、24、32、40、52

Study Arms (1)

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

EXPERIMENTAL

Drug: Ivarmacitinib Sulfate Tablets

Interventions

Ivarmacitinib Sulfate Tablets 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.

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

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• Absolute lymphocyte count of \<0.50 x 10\^9 /L (\<500/mm3);
• Absolute Neutrophil Count (ANC) of \<1 X 10\^9/L (\<1000/mm3);
• 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.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Chen Xiang Xiang Chen

CONTACT

073189753406; chenxiangck@126.com

Su Juan Juan Su

CONTACT

073189753406; sujuanderm@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 11, 2025
• Study Start: November 30, 2025
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): January 30, 2029
• Last Updated: December 11, 2025

Record last verified: 2025-11