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

April 16, 2026 updated by: Chengdu Kangnuoxing Biopharma,Inc.

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group of Stapokibart Injection
Biological: Stapokibart
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 52 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

April 16, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CM310-101301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Atopic Dermatitis (AD)

Clinical Trials on Stapokibart

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Czech Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe