Recruiting NCT07544862
A Study of Stapokibart Injection in Patients With Atopic Dermatitis (AD)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Stapokibart.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis (AD). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study of Stapokibart Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
Overview
This study is an open label, prospective study to evaluate the safety and efficacy of Stapokibart Injection in patients with AD.
Interventions
- Biological Stapokibart
subcutaneous injection
Primary outcome measures
- The incidence rate of adverse reactions [Time frame: From enrollment to the end of treatment at 52 weeks.]
Eligibility criteria
Inclusion criteria
- Trial participants aged 18 years or older at baseline, with no restrictions on gender.
- Physician decision to treat trial participants with Stapokibart Injection for AD (according to the China-specific prescribing information) made prior to and independently of the participant's participation in the study.
Exclusion criteria
- Known history of allergic reaction to Stapokibart Injection.
- Trial participants currently or plan participating in any interventional clinical trial.
- Trial participants with hematologic malignancies.
- Women with pregnant.
- Any condition that, in the opinion of the investigator, may interfere with trial participants' ability to participate in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07544862 · CM310-101301