A Phase 4 interventional study of Stapokibart and Mometasone Furoate Nasal Spray (MFNS) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), Biological Therapy and Biomarkers, sponsored by Beijing Tongren Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-06.
Sponsored by Beijing Tongren Hospital · Phase 4, Interventional, and Treatment
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.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's planned enrollment of 90 is above the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Beijing Tongren Hospital is the lead sponsor of 164 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stapokibart subcutaneously every two weeks plus mometasone furoate nasal spray 200 μg once daily
Biological: Stapokibart · Drug: Mometasone Furoate Nasal Spray (MFNS)
Stapokibart subcutaneously every two weeks
mometasone furoate nasal spray 200 μg once daily
Nasal Polyps Score (NPS)
NPS score ranges from 0-8 (sum of 0-4 for each nasal), higher score means a worse outcome.
Time frame: 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.
Time frame: week 16
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: week 16
Pulmonary function test
Change from baseline in forced expiratory volume in 1 second (FEV1) at each evaluation timepoint for participants with asthma.
Time frame: 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.
Time frame: 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.
Time frame: Week 2，4，8，12，16
Pharmacodynamics
Change from baseline in serum biomarker level (eosinophil level).
Time frame: Week 4，8，12，16，20，24，28，32，36，40
Pharmacodynamics
Change from baseline of eosinophil level in nasal polyps biospy tissue.
Time frame: week 16
The change of biomarkers
Changes from baseline of expression levels of biomarker in nasal brush exfoliated cells, nasal secretions and nasal microbes.
Time frame: 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.
Time frame: 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.
Time frame: week 16
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Dec 2025, 10 months later.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Stapokibart