atopic dermatitis
Conditions
Interventions
weekend-treated group:upadacitinib 15mg qd for 2 consecutive days per week till 21 weeks
alternative-day-treated group:upadacitinib 15mg qod for 12 weeks, follow up till 21 weeks
Sponsors
The Eighth Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Patients must be =12 years old with moderate-to-severe (IGA-AD =3 and BSA =10% before starting upadacitinib treatment) atopic dermatitis, and have been treated with upadacitinib 15mg once-daily for more than 3 month with a 90% improvement in EASI score from baseline (EASI-90). 2. No prior exposure to any JAK inhibitor, oral immunosuppressant, systemic corticosteroids, or phototherapy treatment within 3 months. 3. Patients are willing to sign informed consents, adhere to protocol and follow-up visits. 4. EASI score at the baseline visits (=3 days before starting upadacitinib treatment) must be recorded.
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients participate in other trials. 2. Prior exposure to any biologics that may cause lymphocytopenia (including but not limited to rituximab) within 6 months, or other biologics within 16 weeks. 3. Patients prepare for pregnancy in one year, plan to use contraindicated drugs or to have major operations in 6 months. 4. Patients received any live vaccine within 3 months. 5. Prior exposure to any systemic antibiotics, antifungal agents, or antiviral agents within 2 weeks. 6. Patients suffered from immunodeficiency disease or serious infectious disease (including but not limited to virus hepatitis, tuberculosis, invasive fungal disease). 7. History of any malignancy except for successfully treated non-melanoma skin cancer. 8. Patients developed severe adverse events during upadacitinib induction treatment. 9. History of critical underlying medical conditions, other cutaneous diseases or laboratory abnormalities, which investigator determines, would interfere with the patients participation in this study or would lead to bias of final results. 10. Females with positive serum/urine pregnancy tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieve at least a 90% improvement in EASI score from initial baseline (EASI-90) at 21 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieve at least a 75% improvement in EASI score from initial baseline (EASI-75) at 21 weeks.;The proportion of patients with less than 50% improvement in EASI score from initial baseline (AD flare) at 21 weeks.;The number and proportion of treatment-emergent adverse events, serious adverse events, adverse events leading to death, adverse events considered to be related to upadacitinib, adverse events leading to discontinuation of upadacitinib during study.;The average improvement in NRS score during study.;The average improvement in ADCT and DLQI scores during study.; | — |
Countries
China
Contacts
Public ContactZhang zhenying
The Eighth Affiliated Hospital Sun Yat-sen University
Outcome results
None listed