A Study of Stapokibart Injection in Patients With Atopic Dermatitis (AD)

NCT07544862 — Recruiting, 1000 participants, Chengdu Kangnuoxing Biopharma,Inc.

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A Prospective Study of Stapokibart Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)

Registry	NCT07544862
Status	Recruiting
Study type	Observational
Enrollment	1000 (Estimated)
Sponsor	Chengdu Kangnuoxing Biopharma,Inc. (Industry)
Conditions	Atopic Dermatitis (AD)
Interventions	Stapokibart (Biological)
Dates	start 2026-06-02, primary completion 2027-12-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-04-22, last updated 2026-06-10
Locations	1 site in China

-Summary

This study is an open label, prospective study to evaluate the safety and efficacy of Stapokibart Injection in patients with AD.

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+Arms and interventions

Arm	Type	Interventions	Description
Group of Stapokibart Injection		Biological: Stapokibart

Stapokibart (Biological): subcutaneous injection

+Outcome measures

Primary outcomes

The incidence rate of adverse reactions [From enrollment to the end of treatment at 52 weeks.]: Number of Adverse Reactions is calculated based on Adverse Events and Serious Adverse Events that were assessed by the investigator as related to the study drug and categorized according to the Medical Dictionary for Regulatory Activities.

+Eligibility

Sex: All, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
Peking University People's Hospital	Beijing, Beijing Municipality	China	Recruiting