A Study of Stapokibart Injection in Patients With Atopic... | NCT07544862

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

NCT07544862

Sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Status

Recruiting

Last Update Posted

Jun 10, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Atopic Dermatitis (AD)

Interventions

Stapokibart

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2026Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

Apr 16, 2026

First Submission Date that Met QC Criteria

Apr 16, 2026

First Posted Date

Apr 22, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2026

Last Update Posted Date

Jun 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

52 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group of Stapokibart Injection			Biological: Stapokibart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stapokibart	Biological	subcutaneous injection	Group of Stapokibart Injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qian Jia	Contact	028-88610620		clinicaltrial@keymedbio.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University People's Hospital	Recruiting	Beijing	Beijing Municipality		China

Condition Browse Module

MeSH Terms

ID	Term
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis

Browse Leaves

Not provided

Browse Branches

Not provided