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

NCT07544862 | Not Yet Recruiting

• 1 other identifier: CM310-101301
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (1)

• The incidence rate of adverse reactions

  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.

  From enrollment to the end of treatment at 52 weeks.

Study Arms (1)

Group of Stapokibart Injection

Biological: Stapokibart

Interventions

Stapokibart BIOLOGICAL

subcutaneous injection

Group of Stapokibart Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are treated with Stapokibart Injection for AD at the physician's discretion (according to the China-specific prescribing information).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Kangnuoxing Biopharma,Inc.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Qian Jia

CONTACT

028-88610620; clinicaltrial@keymedbio.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

CN (1)