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 aims to evaluate the effectiveness and safety of Ivarmacitinib in the treatment of moderate-to-severe atopic dermatitis under real-world conditions. It will assess the time to pruritus improvement and skin lesion clearance, collect large-sample safety data, analyze disease improvement across patient subgroups with different baseline characteristics, and explore the impact of various maintenance treatment regimens on disease recurrence. 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. Subsequently, those who respond adequately may transition to an individualized maintenance regimen until week 52.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
Xiangya Hospital of Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 12 and 75 years; * Diagnosed with moderate-to-severe atopic dermatitis (AD) ; * Participants (and legal representatives for adolescents) able to understand and communicate with the investigator.
Exclusion criteria
* 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: 1. Absolute lymphocyte count of \<0.50 x 10\^9 /L (\<500/mm3); 2. Absolute Neutrophil Count (ANC) of \<1 X 10\^9/L (\<1000/mm3); 3. Hemoglobin level \< 80 g/L. * 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. * 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. * Subjects with clinically significant diseases of the heart, liver, kidney, or other major organ systems. * Female subject who is pregnant, breastfeeding, or considering pregnancy during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving at Least a 75% Reduction in Eczema Area and Severity Index Score (EASI 75) From Baseline at Week 16 | Baseline and Week 16 | EASI is a tool used to measure the extent (area) and severity of atopic dermatitis based on assessments of the head/ neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness , thickness, scratching, and lichenification. The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients achieving an Investigator's Global Assessment (IGA) response at each scheduled visit, defined as an IGA score of 0 or 1 with at least a 2-point reduction from baseline. | Baseline and Week 1、2、4、8、12、16、24、32、40、52 | The IGA is a validated assessment instrument to rate the severity of atopic dermatitis globally, based on the following scale: 0 - Clear: No inflammatory signs of AD; 1. \- Almost clear: Barely perceptible erythema, induration/papulation and/or lichenification, no oozing or crusting; 2. \- Mild: Slight but definite erythema, induration/papulation and/or minimal lichenification, no oozing or crusting; 3. \- Moderate: Clearly perceptible erythema, induration/papulation and/or lichenification, oozing or crusting may be present; 4. \- Severe: Marked erythema, induration/papulation and/or lichenification; Oozing or crusting may be present. |
| The proportion of subjects achieving EASI 75 at each scheduled visit. | Baseline and Week 1、2、4、8、12、24、32、40、52 | — |
| Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Patient Oriented Eczema Measure (POEM) Total Score | Baseline and Week 1、2、4、8、12、16、24、32、40、52 | The POEM is a 7-item, validated questionnaire used to assess disease symptoms in both children and adults. Participants respond to 7 questions, including dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping, each scored on a 5-point scale based on frequency of occurrence during the previous week: 0 = no days, 1 = 1 to 2 days, 2 = 3 to 4 days, 3 = 5 to 6 days, and 4 = all days. Item scores are added to provide a total score ranging from 0 (clear) to 28 (very severe atopic eczema). A change in POEM score of 3.4 points is considered the minimal clinically important difference. |
| Time to achieve a ≥4-point improvement from baseline in the Worst Itch Numerical Rating Scale (WI-NRS). | Baseline and Day 7 | Participants were asked to rate itch (pruritus) intensity at its worst during the past 24 hours on a daily basis using an 11-point scale from 0 (no itch) to 10 (worst imaginable itch). |
| The recurrence of atopic dermatitis. | Week 16、52 | — |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | From Baseline to 30 days following last dose of study drug (Week 52) | — |
| Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Dermatology Life Quality Index (DLQI) | Baseline and Week 1、2、4、8、12、16、24、32、40、52 | 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
Primary ContactChen Xiang Xiang Chen
Backup ContactSu Juan Juan Su
Outcome results
None listed