Efficacy and Safety of Switching to Ivarmacitinib in Patients With Moderate-to-Severe Atopic Dermatitis With Inadequate Response to Interleukin-4 Receptor Alpha(IL-4Rα) Inhibitors: A Prospective, Multicenter, Real-World Study

NCT07550452 | Not Yet Recruiting

• 1 other identifier: MA-DER-RWS-103
• Study Type: interventional
• Target: 300
• 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 assessed the efficacy and safety of switching to the JAK1 inhibitor ivarmacitinib over 16 weeks in patients with moderate-to-severe atopic dermatitis and inadequate response to IL-4Rα inhibitors under real-world conditions. 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 (2)

• Eczema Area and Severity Index (EASI 75) at Week 16

  Proportion of subjects achieving at least a 75% improvement in Eczema Area and Severity Index (EASI 75) from baseline at Week 16

  16 Weeks

• Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16

  Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16

  16 Weeks

Secondary Outcomes (5)

• Investigator's Global Assessment (IGA) score of 0/1 at Week 16

  16 Weeks

• EASI 75 at Week 2, 4, 8 and 12

  Week 2, 4, 8 and 12

• Worst-Itch Numeric Rating Scale (WI-NRS) at Week 2, 4, 8 and 12

  Week 2, 4, 8 and 12

• Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 2, 4, 8, 12 and 16

  Day 1 to Week 16

• Change of dermatology life quality index (DLQI) from baseline at Week 2, 4, 8, 12, and 16

  Day 1 to Week 16

Study Arms (1)

Ivarmacitinib for Moderate-to-Severe Atopic Dermatitis with Inadequate Response to IL-

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.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.

Ivarmacitinib for Moderate-to-Severe Atopic Dermatitis with Inadequate Response to IL-

Eligibility Criteria

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

You may qualify if:

• Aged between 18 and 75 years.
• Patients diagnosed with moderate-to-severe atopic dermatitis and treated with IL-4Rα inhibitors according to standard regimens for a minimum of 12 weeks.
• Meeting any of the following disease activity criteria: EASI ≥16, WI-NRS ≥4.

You may not qualify if:

• Treatment with other JAK inhibitors, including topical formulations, within one week before enrollment.
• Subjects with clinically significant diseases of the heart, liver, kidney, or other major organ systems.
• 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:
• a. Absolute lymphocyte count of \<0.50 x 10\^9 /L (\<500/mm3);b. Absolute Neutrophil Count (ANC) of \<1 X 10\^9/L (\<1000/mm3);c. Hemoglobin level \< 80 g/L.
• 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.
• 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.
• Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.

Sponsors & Collaborators

• Peking University People's Hospital: 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

Zhang Jian zhong

CONTACT

010-88325470; rmzjz@126.com

Zhao Yan

CONTACT

010-88325470; 13311373780@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share