A Study of Stapokibart Injection in Patients With Chronic... | NCT07483268

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

NCT07483268

Sponsor

Chengdu Kangnuoxing Biopharma,Inc.

Status

Active, not recruiting

Last Update Posted

Jun 5, 2026Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

CRSWNP

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 29, 2026Actual

Primary Completion Date

Dec 2027Estimated

Completion Date

Feb 2028Estimated

First Submitted Date

Mar 16, 2026

First Submission Date that Met QC Criteria

Mar 16, 2026

First Posted Date

Mar 19, 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 3, 2026

Last Update Posted Date

Jun 5, 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

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

600Estimated

Label	Type	Description	Intervention Names
Group 1			Biological: Stapokibart

Name	Type	Description	Arm Group Labels	Other Names
Stapokibart	Biological	subcutaneous injection	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence rate of adverse reactions (ADR).	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

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

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing Tongren Hospital, CMU		Beijing	Beijing Municipality		China