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.
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.
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.
Single group
Ivarmacitinib Sulfate Tablets
DrugPatients 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.
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
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
Investigator's Global Assessment (IGA) score of 0/1 at Week 16
Proportion of subjects achieving Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) and a reduction from baseline of ≥2 points at Week 16
EASI 75 at Week 2, 4, 8 and 12
Proportion of subjects achieving EASI 75 at all scheduled visits during placebo-controlled treatment phase except Week 16
Worst-Itch Numeric Rating Scale (WI-NRS) at Week 2, 4, 8 and 12
Proportion of subjects achieving an improvement of WI-NRS ≥4 from baseline at all scheduled visits during placebo-controlled treatment phase other than Week 16
Change of Patient-Oriented Eczema Measure (POEM) from baseline at Week 2, 4, 8, 12 and 16
Change from baseline in Patient-Oriented Eczema Measure (POEM) at all scheduled visits. 7-item, patient-administered scale that assesses disease severity in children and adults. Subjects respond to questions about the frequency of 7 symptoms (itching, sleep disturbance, bleeding, weeping/oozing, cracking, flaking, and dryness/roughness) over the last week. Response categories include "No days," "1-2 days," "3-4 days," "5-6 days," and "Every day" with corresponding scores of 0, 1, 2, 3, and 4, respectively. Scores range from 0-28 with higher total scores indicating greater disease severity.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
