Atopic dermatitis
Conditions
Interventions
Experimental group:Standardized treatment for atopic dermatitis+Starpokibart injection
Sponsors
Ningbo Traditional Chinese Medicine Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age range: 18-75 years old; (2) Voluntarily participate in this study and sign an informed consent form; (3) Diagnosed as AD according to the corresponding disease guidelines, with reference criteria including Hanifin Rajka criteria and Williams criteria or the American Consensus on Dermatology criteria (2014 edition); (4) Ability to communicate effectively with researchers and follow up on protocol requirements
Exclusion criteria
Exclusion criteria: (1) Received treatment with monoclonal antibodies targeting the same target, anti IgE monoclonal antibodies, other monoclonal antibodies, or other biological agents within the first 3 months of enrollment; (2) Pregnant or women preparing for pregnancy and lactation; (3) Individuals who have received or are preparing to receive attenuated live vaccines within 12 weeks prior to enrollment; (4) Patients with severe infections, severe liver and kidney dysfunction (ALT = 3 times, or/and eGFR = 30mL/min calculated by any formula), malignant tumors, psychiatric disorders, etc; (5) Previous history of human immunodeficiency virus (HIV) infection or HIV antibody positivity during screening period (6) Individuals who are allergic to Sipuximab or any other drug ingredients; (7) The patient is currently participating in other clinical trials and may affect the data collection for this study (8) Researchers believe that there are other situations that are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Eczema area and severity index score, EASI ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily Peak Itch Numerical Rating Scale score, NRS;Dermatology Quality of Life Index score, DLQI;The percentage of patients who had a reduction of 50% or more in the EASI score from baseline (EASI-90);Adverse events (AE), laboratory tests, physical examination, vital signs and other abnormalities were recorded;Laboratory tests: blood routine, liver and kidney function, IgE and other indicators; | — |
Countries
China
Contacts
Public ContactYe Jingjing
Ningbo Traditional Chinese Medicine Hospital
Outcome results
None listed