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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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 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.

Trial design

Treatments tested in this trial

  • Ivarmacitinib Sulfate Tablets

Treatment groups

300 Participants
are divided into 1 treatment group

Locations

This trial has no locations