Atopic Dermatitis (AD)
Conditions
Interventions
Observation group:None
Sponsors
Dematology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female aged >= 45 years; 2. Patients with a definite diagnosis of atopic dermatitis and Zhang's criteria according to Williams criteria: Williams Diagnostic Criteria: The basic characteristics are: 1) Itching: Patients have clear itching symptoms. 2) Typical rash morphology and distribution: lichenification or strip-like manifestations in adults, such as elbow fossa, popliteal fossa, neck and other parts; The skin on the face and extensor sides of the child is affected, especially on the cheeks. 3) Personal or family history of atopic diseases: personal history: asthma, allergic rhinitis or atopic dermatitis; Family history: History of atopic disease in first-degree relatives (for children under 4 years of age). 4) Dry skin all over the body: A history of dry skin all over the body in the past year. 5) Age of onset: Onset before 2 years old (for patients over 4 years old). 3. History of poor topical treatment: Such patients are the target population of this study, especially those who have experienced moderate to severe atopic dermatitis who have not responded to traditional topical treatment; Affected body surface area (BSA) >= 10%; Eczema Area and Severity Index (EASI) >= 16; Verified Investigator's Global Assessment of Patients with Atopic Dermatitis (vIGA-AD) >= 3 points; Weekly average worst pruritus numeric scoring scale (WP-NRS) score of >= 4 points at baseline; 4. Volunteer to participate in this study and sign the informed consent form; 5. Able to communicate well with the investigator and comply with the protocol requirements for follow-up
Exclusion criteria
Exclusion criteria: 1: Women who are pregnant, breastfeeding, or planning to become pregnant in the near future; 2: Subjects with severe infections, significant liver or kidney dysfunction (ALT >= 3× ULN or eGFR <= 30 mL/min); 3: History of malignancy; 4: History of HIV infection or HIV antibody positive during screening; 5: Known hypersensitivity to stapokibart (CM310) or any of its components; 6: Participation in other clinical trials that may interfere with data collection in this study; 7: Any other condition deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigator’s Global Assessment for Atopic Dermatitis;Eczema Area and Severity Index (EASI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index (DLQI);Numeric Rating Scale for Pruritus and Sleep Disturbance; | — |
Countries
China
Contacts
Public ContactYongfeng chen
Dematology Hospital of Southern Medical University
Outcome results
None listed