A Study of Stapokibart Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) .

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

A Prospective Study of Stapokibart Injection in Patients With CRSwNP.

This study is a open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with CRSwNP.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

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

Participant who are treated with Stapokibart Injection for CRSwNP (according to the China-specific prescribing information) .

Description

Inclusion Criteria:

  • Participants aged 18 years or older at the time of informed consent and provide voluntary informed consent to participate in the study before inclusion in the study.
  • Physician decision to treat the participant with Stapokibart Injection for CRSwNP (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.
  • Participants currently or plan participating in any interventional clinical trial.
  • Participants with hematologic malignancies.
  • Women with pregnant.
  • Any condition that, in the opinion of the Investigator, may interfere with the participant's 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 1
Biological: Stapokibart
subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence rate of adverse reactions (ADR).
Time Frame: From enrollment to the end of treatment at 52 weeks
Number of adverse events and severe adverse events, categorized according to medical dictionary for regulatory activities (MedDRA)
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

March 16, 2026

First Submitted That Met QC Criteria

March 16, 2026

First Posted (Actual)

March 19, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CM310-102302

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.

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