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NCT Number: NCT07544862

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

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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Key information

Conditions

Atopic Dermatitis (AD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Qian Jia

CONTACT

[email protected]

028-88610620

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stapokibart

Biological

subcutaneous injection

Primary outcomes

  1. The incidence rate of adverse reactions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Qian Jia

CONTACT

[email protected]

028-88610620

Sponsors and collaborators

Lead sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Apr 22, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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