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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07544862
Enrollment
1000
Registered
2026-04-22
Start date
2026-06-01
Completion date
2028-02-01
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis (AD)

Brief summary

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

Interventions

BIOLOGICALStapokibart

subcutaneous injection

Sponsors

Chengdu Kangnuoxing Biopharma,Inc.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The incidence rate of adverse reactionsFrom 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.

Countries

China

Contacts

CONTACTQian Jia
clinicaltrial@keymedbio.com028-88610620

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026