CRSWNPNCT07483268
A Study of Stapokibart Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
An observational study of CRSWNP, run by Chengdu Kangnuoxing Biopharma,Inc. at 1 site in China.
Trial summary
This study is a open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with CRSwNP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CRSWNP
- What is being tested?
- Stapokibart
- Type of treatment
- Injection or infusion
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2026to Feb 2028
- How long will I take part?
- 52 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participant who are treated with Stapokibart Injection for CRSwNP (according to the China-specific prescribing information) .
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- CRSWNP
- Being tested
- Stapokibart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StapokibartBiological
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Biological: Stapokibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rate of adverse reactions (ADR).
Number of adverse events and severe adverse events, categorized according to medical dictionary for regulatory activities (MedDRA)
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start29 May 2026
- Primary completionDec 2027 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRSWNPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 52 Weeks
Sponsor and investigators
- Lead sponsor
- Chengdu Kangnuoxing Biopharma,Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07483268
- Sponsor's protocol ID
- CM310-102302
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Stapokibart Injection in Patients With CRSwNP
- ClinicalTrials.gov ID
- NCT07483268
- Acronym / sponsor ID
- CM310-102302
- Conditions
- CRSWNP
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Chengdu Kangnuoxing Biopharma,Inc.Industry (pharma, biotech, devices)
- Study start
- 29 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a open label, prospective study to evaluate the safety of Stapokibart Injection in subjects with CRSwNP.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 52 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Stapokibart |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participant who are treated with Stapokibart Injection for CRSwNP (according to the China-specific prescribing information) .
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapokibartsubcutaneous injection | Biological | Group 1 |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
Related trials for CRSWNP
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
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RecruitingObservational study
Prospective, Non-interventional Single-arm Study With Tezepelumab to Investigate the Change in Clinical and Patient-reported Outcomes in Patients With CRSwNP in Real-world (PETRICHOR)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingObservational study
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Nasal Polyps
RecruitingObservational study
ReAl-woRld Evaluation of tEzepelumab for Chronic rhinoSinusitis With Nasal Polyps in Russia
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CRSWNP, run by Chengdu Kangnuoxing Biopharma,Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rate of adverse reactions (ADR). (time frame: From enrollment to the end of treatment at 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.