NCT07550452Not yet recruiting
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
Efficacy and Safety of Switching to Ivarmacitinib in Patients With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to IL-4Rα Inhibitors
Source: ClinicalTrials.gov · Last updated 24 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 19 Apr 2026
- Start date
- 31 Mar 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Atopic dermatitis (eczema)
- NCT number
- NCT07550452
What you commit to
- Study type: Interventional
- Planned participants: 300
- From 31 Mar 2026 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with other JAK inhibitors, including topical formulations, within one week before enrollment.
- 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.
Other illness
- Subjects with clinically significant diseases of the heart, liver, kidney, or other major organ systems.
- 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.
Lab values
- 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);b. Absolute Neutrophil Count (ANC) of \<1 X 10\^9/L (\<1000/mm3);c. Hemoglobin level \< 80 g/L.
Other
- Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.