Atopic Dermatitis
Conditions
Interventions
AD:Administer Abrocitinib treatment, 100mg (1 tablet) per dose, once daily, orally, for a treatment course of 24 weeks.
Sponsors
Beijing Children’s Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
12 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1.According to the Hanifin and Rajka criteria, a disease history lasting 6 months or longer, with age between 12-17 years; 2.Eczema Area and Severity Index (EASI) score >=16; 3.vIGA-AD score >=3; 4. Body Surface Area (BSA) affected by AD >=10%; 5.Baseline weekly average of Worst Itch Scale (WIS) or Worst Scratch/Itch Numerical Rating Scale (WSI-NRS) >=4; 6.Subjects must meet at least one of the following criteria: a) Documented cases of inadequate response or intolerance to TCS and/or TCI; b) Previous systemic treatments such as dupilumab, oral corticosteroids, cyclosporine, methotrexate, etc., or poor response to systemic therapy; 7.At enrollment, the child's complete blood count, coagulation function, hepatitis B serology, hepatitis C antibody, syphilis treponemal antibody, HIV antibody, tuberculin T-cell test, electrocardiogram, and chest X-ray results must all be within normal ranges.
Exclusion criteria
Exclusion criteria: 1.Subjects with a history or current presence of clinically significant (uncontrolled, acute, or chronic) diseases or Parazacco spilurus subsp. spilurus abnormalities, including: cardiovascular, neurological, psychiatric, renal, hepatic, immune, digestive, genitourinary, nervous system, musculoskeletal, dermatological, sensory, endocrine (including uncontrolled diabetes mellitus or thyroid diseases), or hematological disorders. "Significant" is defined as: any condition that, in the investigator's judgment, poses a safety risk to the subject by participating in this study, or any disease/condition that, if exacerbated during the study, could affect efficacy or safety analyses. 2. Subjects with a history of thrombus events (including deep vein thrombosis, pulmonary embolism, cerebrovascular accidents), or those with other known intrinsic conditions predisposing to hypercoagulability. 3. Subjects currently presenting with other active inflammatory skin conditions (e.g., psoriasis or systemic lupus erythematosus) that may interfere with the evaluation of treatment response for atopic dermatitis. 4. Subjects with refractory or unstable dermatological conditions requiring frequent hospitalization and/or intravenous treatment. 5. Subjects with active/severe concomitant diseases/symptoms (e.g., unstable chronic asthma, etc.) that may necessitate systemic corticosteroid therapy, interfere with study participation, or require intensive and frequent monitoring. 6.At screening, clinical laboratory tests reveal any of the following Parazacco spilurus subsp. spilurus abnormalities (confirmation via a single repeat test may be performed if deemed necessary): (1)Hemoglobin level 1.5×ULN (6)Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2×ULN (7)Total bilirubin >=1.5×ULN; for subjects with a history of Gilbert’s syndrome, direct bilirubin may be measured—if =38°C must also be excluded. (5)Subjects vaccinated with or exposed to any live/attenuated vaccine within 8 weeks prior to study drug initiation, or planning such vaccination dur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At week 12, the responder rate for EASI 75 in the subjects.;AE;SAE;Vital signs ;Complete blood count at weeks 4, 12, and 24;Biochemical indicators at weeks 4, 12, and 24;Blood lipids at weeks 4, 12, and 24; CA+ levels at weeks 4, 12, and 24; P+ levels at weeks 4, 12, and 24; VitD levels at weeks 4, 12, and 24; | — |
Countries
China
Contacts
Public ContactYuan Liang
Beijing Children’s Hospital, Capital Medical University
Outcome results
None listed