Atopic Dermatitis
Conditions
Interventions
Experimental group:Adult patients with moderate-to-severe atopic dermatitis (AD) involving special body sites were treated with spesolimab. The treatment regimen consisted of an initial dose of 600?mg
Sponsors
The First Affiliated Hospital of Guilin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Meet the diagnostic criteria for Chinese AD as per the "Chinese Guidelines for the Treatment of Atopic Dermatitis (2020 Edition)"; 2.Disease severity at screening and baseline is moderate to severe, including an IGA score >= 3 or an EASI score >= 7.1; 3.Involvement of special sites such as the scalp, face, breasts, vulva, hands, or feet; 4.Age >= 18 years at the baseline visit, regardless of gender; 5.Poorly controlled with topical treatment or topical treatment are unsuitable; 6.Willing to participate in the study and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.Individuals with a hypersensitivity reaction to the active ingredient of stapokibart or any of its excipients; 2.Patients who are currently participating in or planning to participate in other interventional studies during the study period; 3.Patients who have previously used stapokibart; 4.Any condition that, in the opinion of the investigator, may interfere with the patient's participation in the study, such as chronic active infections including hepatitis B, tuberculosis, HIV/AIDS, etc.; patients with malignant tumors or severe organic diseases; or other comorbidities that could foreseeably affect the patient's ability to adequately complete visits and assessments; 5.Any other factors deemed by the investigator to make the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The EASI 75 response rate at week 16; | — |
Secondary
| Measure | Time frame |
|---|---|
| IGA 0/1 response rate at Week 16;EASI 75 and EASI 90 response rates;Changes from baseline in SCORAD, DLQI, ADCT, PP-NRS, and BSA; | — |
Countries
China
Contacts
Public ContactChen Fangru
The First Affiliated Hospital of Guilin Medical University
Outcome results
None listed