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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ivarmacitinib Sulfate Tablets.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis (AD). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Switching to Ivarmacitinib in Patients With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to IL-4Rα Inhibitors
Overview
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.
Interventions
- Drug Ivarmacitinib Sulfate Tablets
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.
Primary outcome measures
- Eczema Area and Severity Index (EASI 75) at Week 16 [Time frame: 16 Weeks]
- Worst-Itch Numeric Rating Scale (WI-NRS-4)-4 at Week 16 [Time frame: 16 Weeks]
Secondary outcome measures (5)
- Investigator's Global Assessment (IGA) score of 0/1 at Week 16 [Time frame: 16 Weeks]
- EASI 75 at Week 2, 4, 8 and 12 [Time frame: Week 2, 4, 8 and 12]
- Worst-Itch Numeric Rating Scale (WI-NRS) at Week 2, 4, 8 and 12 [Time frame: Week 2, 4, 8 and 12]
- Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 2, 4, 8, 12 and 16 [Time frame: Day 1 to Week 16]
- Change of dermatology life quality index (DLQI) from baseline at Week 2, 4, 8, 12, and 16 [Time frame: Day 1 to Week 16]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07550452 · MA-DER-RWS-103