Atopic Dermatitis (AD)
Conditions
Keywords
Atopic Dermatitis, Ivarmacitinib
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.
Interventions
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI 75) at Week 16 | 16 Weeks | 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 | 16 Weeks | Proportion of subjects achieving an improvement of Worst-Itch Numeric Rating Scale (WI-NRS) ≥4 from baseline at Week 16 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Global Assessment (IGA) score of 0/1 at Week 16 | 16 Weeks | 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 | 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 | 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 | Day 1 to Week 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. |
| Change of dermatology life quality index (DLQI) from baseline at Week 2, 4, 8, 12, and 16 | Day 1 to Week 16 | The DLQI is a 10-item validated questionnaire used to assess the impact of AD disease symptoms and treatment on quality of life (QoL). It consists of 10 questions evaluating impact of skin diseases on different aspects of a participant's QoL over the prior week, including symptoms and feelings, daily activities, leisure, work or school, personal relationships, and the side effects of treatment. Each item is scored on a 4-point scale (0 = not at all/not relevant; 1 = a little; 2 = a lot; and 3 = very much). Item scores are added to provide a total score, ranging from 0 to 30, with higher scores indicating greater impairment of QoL. |
Contacts
CONTACTZhang Jian zhong
CONTACTZhao Yan
Outcome results
None listed