ClinicalTrials.gg
Active, not recruitingNCT07483268Updated Jun 5, 2026

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

An observational study in CRSWNP, sponsored by Chengdu Kangnuoxing Biopharma,Inc.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.

Sponsored by Chengdu Kangnuoxing Biopharma,Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • CRSWNP
03

In context

Lead sponsor

Chengdu Kangnuoxing Biopharma,Inc. is the lead sponsor of 6 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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) .

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants aged 18 years or older at the time of 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

Exclusion Criteria:

  • Known history of allergic reaction to Stapokibart Injection.
  • Participants currently or plan participating in any interventional clinical trial.
  • Participants with hematologic .
  • Women with pregnant.
  • Any condition that, in the opinion of the Investigator, may interfere with the participant's ability to participate in the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
52 Weeks
Patient registry
Yes

Groups and cohorts

  • Group 1

    Biological: Stapokibart

Interventions

06

What researchers measure

Primary outcomes

  1. The incidence rate of adverse reactions (ADR).

    Number of adverse events and severe adverse events, categorized according to medical dictionary for regulatory activities (MedDRA)

    Time frame: From enrollment to the end of treatment at 52 weeks

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2026 (actual). Primary completion is estimated for Dec 2027, 19 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2026
First posted
Mar 19, 2026
StartActual
May 29, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Feb 2028
Last update
Jun 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07483268
Lead sponsor
Chengdu Kangnuoxing Biopharma,Inc.
Responsible party
Sponsor
First posted
Mar 19, 2026
Start date
May 29, 2026
Primary completion
Dec 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Jun 5, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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