Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)Phase 4NCT06801353
A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps
A Phase 4 study testing Stapokibart and Mometasone Furoate Nasal Spray (MFNS) in people with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Biological Therapy, run by Beijing Tongren Hospital at 1 site in China.
Trial summary
Recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, not every patient responds to these treatments. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Biological Therapy, Biomarkers
- What is being tested?
- Stapokibart and Mometasone Furoate Nasal Spray (MFNS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 1 Jul 2026
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old.
- With bilateral chronic rhinosinusitis with nasal polyposis.
- Nasal Polyp Score ≥4 (minimum score of 2 per nasal cavity) at baseline.
- Nasal congestion score ≥2 at baseline.
- Patients who have received systemic corticosteroids (SCS) treatment within 2 years before screening, and/or have contraindications or intolerance to SCS treatment, and/or received surgical for nasal polyps more than 6 months before screening.
- Have been using intranasal corticosteroids (INCS) at a stable dose for at least 4 weeks before screening.
- Symptoms of nasal obstruction and additional symptoms such as loss of smell or rhinorrhea should be present for at least 4 weeks before screening.
- Good adherence.
Who cannot join
- Not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives [whichever is longer] before baseline).
- Use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer).
- Initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional Chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline.
- Subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for Nasal Polyp Score.
- Participants with a forced expiratory volume in 1 second (FEV1) ≤50% of predicted normal during screening/run-in period.
- Hypersensitivity to MFNS or anti-IL-4R monoclonal antibodies or stapokibart components.
- Concomitant with other poorly controlled serious diseases or recurrent chronic diseases.
- Women who are pregnant, breastfeeding, or planning either during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100000
Chengshuo Wang, +86-13911623569, wangcs830@126.com
About this study
Recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, not every patient responds to these treatments. This clinical trial aims to develop a non-invasive predictive model to help determine how effective IL-4Rα targeted monoclonal antibody therapy will be for individuals with CRSwNP.
- Being tested
- Stapokibart, Mometasone Furoate Nasal Spray (MFNS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StapokibartBiological
Stapokibart subcutaneously every two weeks
Mometasone Furoate Nasal Spray (MFNS)Drug
mometasone furoate nasal spray 200 μg once daily
| Study group | Role | What they receive |
|---|---|---|
| therapy group | Experimental | Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily Receives: Biological: Stapokibart; Drug: Mometasone Furoate Nasal Spray (MFNS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Polyps Score (NPS)
NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
Measured: week 16
Nasal Congestion Score (NCS)
Change from baseline in the Nasal Congestion Score (NCS) at week 16. NCS score range from 0 to 3, with higher score means worse nasal symptom.
Measured: week 16
Secondary outcomes (14)
Nasal Polyp Score (NPS)
Changes from baseline in nasal polyp score (NPS) at each evaluation time point. NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
Measured: Week 2，4，8，12，20，24，28，32，36，40
Nasal Congestion Score (NCS)
Changes from baseline in nasal congestion score (NCS) at each evaluation time point. NCS score range from 0 to 3, with higher score means worse nasal symptom.
Measured: Week 2，4，8，12，20，24，28，32，36，40
sino-nasal outcome test-22 (SNOT-22)
Changes from baseline in sino-nasal outcome test-22 (SNOT-22) score at each evaluation time point. The SNOT-22 score is the sum of the scores of 22 items, ranging from 0 to 110 (higher scores indicate worse outcomes).
Measured: Week 2，4，8，12，20，24，28，32，36，40
nasal total symptom score (TSS)
Changes from baseline in nasal total symptom score (TSS) at each evaluation timepoint. The evaluation content of TSS includes three aspects: nasal congestion, loss of smell and running nose. Each aspect has a score of 0-3 with a total score of 0-9. The higher score indicates the more severe overall symptom.
Measured: Week 2，4，8，12，20，24，28，32，36，40
Asthma Control Questionnaire (ACQ-6)
Changes from baseline in Asthma Control Questionnaire (ACQ-6) at each evaluation timepoint for participants with asthma. The ACQ-6 is a questionnaire used to evaluate the degree of asthma control. Each question is scored from 0 to 6 according to its severity. The higher the score, the less satisfactory symptom control is.
Measured: Week 2，4，8，12，20，24，28，32，36，40
Lund-Mackay CT score
Change from baseline in Lund-Mackay CT score evaluated by sinus computed tomography (CT) at each evaluation timepoint. The total Lund-Mackay score ranges from 0 to 24 points. The six parts of the nasal sinuses on both sides are evaluated separately. The higher the score, the more severe the CRS condition.
Measured: week 16
Pulmonary function test
Change from baseline in forced expiratory volume in 1 second (FEV1) at each evaluation timepoint for participants with asthma.
Measured: week 16
Change of NPS
Proportion of participants with ≥1 point improvement from baseline in NPS at each evaluation timepoint. Proportion of participants with ≥2 point improvement from baseline in NPS at each evaluation timepoint.
Measured: Week 2，4，8，12，16
Change of NCS
Proportion of participants with ≥1 point improvement from baseline in NCS at each evaluation timepoint. Proportion of participants with ≥2 point improvement from baseline in NCS at each evaluation timepoint.
Measured: Week 2，4，8，12，16
Pharmacodynamics
Change from baseline in serum biomarker level (eosinophil level).
Measured: Week 4，8，12，16，20，24，28，32，36，40
Pharmacodynamics
Change from baseline of eosinophil level in nasal polyps biospy tissue.
Measured: week 16
The change of biomarkers
Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.
Measured: Week 8，16，24，32，40
Pulmonary function test
Change from baseline in forced vital capacity (FVC) at each evaluation timepoint for participants with asthma.
Measured: week 16
Pulmonary function test
Change from baseline in mean flow with forced expiratory volume of 25% ~ 75% vital capacity (FEF25 ~ 75%) at each evaluation timepoint for participants with asthma.
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06801353
- Sponsor's protocol ID
- TR-Biological treatment of NP
- Status last verified
- Dec 2024
- First submitted
- 13 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps
- ClinicalTrials.gov ID
- NCT06801353
- Acronym / sponsor ID
- TR-Biological treatment of NP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 30 Jan 2025 (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.
Recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, not every patient responds to these treatments. This clinical trial aims to develop a non-invasive predictive model to help determine how effective IL-4Rα targeted monoclonal antibody therapy will be for individuals with CRSwNP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| therapy group | Experimental | Biological: Stapokibart, Drug: Mometasone Furoate Nasal Spray (MFNS)Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years old.
- With bilateral chronic rhinosinusitis with nasal polyposis.
- Nasal Polyp Score ≥4 (minimum score of 2 per nasal cavity) at baseline.
- Nasal congestion score ≥2 at baseline.
- Patients who have received systemic corticosteroids (SCS) treatment within 2 years before screening, and/or have contraindications or intolerance to SCS treatment, and/or received surgical for nasal polyps more than 6 months before screening.
Key exclusion criteria (8 listed)
- Not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives [whichever is longer] before baseline).
- Use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer).
- Initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional Chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline.
- Subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for Nasal Polyp Score.
- Participants with a forced expiratory volume in 1 second (FEV1) ≤50% of predicted normal during screening/run-in period.
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 |
|---|---|---|
| StapokibartStapokibart subcutaneously every two weeks | Biological | therapy group |
| Mometasone Furoate Nasal Spray (MFNS)mometasone furoate nasal spray 200 μg once daily | Drug | therapy group |
Primary outcome
Nasal Polyps Score (NPS)
Time frame: week 16
NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
Nasal Congestion Score (NCS)
Time frame: week 16
Change from baseline in the Nasal Congestion Score (NCS) at week 16. NCS score range from 0 to 3, with higher score means worse nasal symptom.
14 secondary outcomes
Nasal Polyp Score (NPS)
Time frame: Week 2，4，8，12，20，24，28，32，36，40
Nasal Congestion Score (NCS)
Time frame: Week 2，4，8，12，20，24，28，32，36，40
sino-nasal outcome test-22 (SNOT-22)
Time frame: Week 2，4，8，12，20，24，28，32，36，40
nasal total symptom score (TSS)
Time frame: Week 2，4，8，12，20，24，28，32，36，40
Asthma Control Questionnaire (ACQ-6)
Time frame: Week 2，4，8，12，20，24，28，32，36，40
Lund-Mackay CT score
Time frame: week 16
Pulmonary function test
Time frame: week 16
Change of NPS
Time frame: Week 2，4，8，12，16
Change of NCS
Time frame: Week 2，4，8，12，16
Pharmacodynamics
Time frame: Week 4，8，12，16，20，24，28，32，36，40
Pharmacodynamics
Time frame: week 16
The change of biomarkers
Time frame: Week 8，16，24，32，40
Pulmonary function test
Time frame: week 16
Pulmonary function test
Time frame: week 16
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 6 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stapokibart and Mometasone Furoate Nasal Spray (MFNS) in people with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) and Biological Therapy, run by Beijing Tongren Hospital 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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 6 Feb 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Chengshuo Wang (+86-13911623569, wangcs830@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Polyps Score (NPS) (time frame: week 16). The study lists 2 primary outcomes in all. 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 6 Feb 2025.