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New biologic stapokibart under safety review for stubborn sinus polyps

NCT ID NCT07483268

Disease control Sponsor: Chengdu Kangnuoxing Biopharma,Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing the safety of a new biologic drug called stapokibart in 600 adults with chronic sinusitis and nasal polyps (CRSwNP). Participants receive the drug as a shot under the skin. The main goal is to track any side effects or serious health events. This is an open-label study, meaning everyone knows they are getting the drug, and it focuses on safety rather than how well the drug works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stapokibart (a biologic drug given as a shot under the skin)
What this could lead to
If this drug proves safe and effective, it could offer a new treatment option for people with chronic sinusitis and nasal polyps that is not controlled by other therapies.
What could go wrong
This is an early safety study, not designed to prove the drug works. Side effects may occur, and the drug may not help everyone. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CRSWNP

Contacts and locations

Locations

  • Beijing Tongren Hospital, CMU

    Beijing, Beijing Municipality, China

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