A Phase 3 interventional study of MG-K10 and Placebo in Chronic Rhinosinusitis With Nasal Polyps, sponsored by Shanghai Mabgeek Biotech.Co.Ltd. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Shanghai Mabgeek Biotech.Co.Ltd · Phase 3, Interventional, and Treatment
This study aims to evaluate the efficacy and safety of MG-K10 humanized monoclonal antibody injection in the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). A total of 210 patients aged 18 to 75 years with bilateral CRSwNP are planned to be enrolled and randomized in a 1:1 ratio to receive either MG-K10 or placebo. During the first 24 weeks, participants will receive MG-K10 or placebo; they will subsequently enter a 28-week maintenance treatment period, during which the original placebo group will switch to receive MG-K10, and blinding will be maintained in both groups. MG-K10 is administered subcutaneously once every 4 weeks. Both groups will receive mometasone furoate nasal spray as background therapy from the run-in period through the end of the study. Following the treatment period, participants will be followed up for 8 weeks up to Week 60. The co-primary endpoints are the changes from baseline in Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS) at Week 24; other symptoms, quality of life, safety, pharmacokinetics, pharmacodynamics, and immunogenicity will also be evaluated.
236 studies on the registry are indexed under Nasal Polyps; 68 are open to participants now.
This study's planned enrollment of 210 is above the median of 60 across 181 interventional studies indexed under Nasal Polyps.
Browse Nasal Polyps studies →Shanghai Mabgeek Biotech.Co.Ltd is the lead sponsor of 16 studies on the registry; 11 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.
Continuous concurrent presence of the following symptoms for ≥4 weeks prior to the screening period:
Exclusion Criteria:
Receipt of the following treatments prior to screening:
Patients with comorbid asthma who meet any of the following conditions will be excluded:
Comorbid with other nasal conditions or symptoms, such as:
Any of the following infectious disease screening criteria met at screening:
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental arm: MG-K10. During the first 24 weeks, subcutaneous injections of MG-K10 are administered at an initial dose of 600 mg, followed by 300 mg once every 4 weeks, for a total of 6 doses. At Week 24, MG-K10 300 mg plus matching placebo is administered; thereafter, MG-K10 300 mg is administered once every 4 weeks, for a total of 7 doses during the maintenance treatment phase. All participants use mometasone furoate nasal spray at 200 μg daily as background therapy from the run-in period through study completion at Week 60.
Biological: MG-K10 · Drug: Placebo · Drug: Mometasone Furoate Nasal Spray
Placebo control arm: Placebo followed by switch to MG-K10. During the first 24 weeks, subcutaneous injections of placebo are administered at an initial volume of 4.0 mL, followed by 2.0 mL once every 4 weeks, for a total of 6 doses. At Week 24, participants switch to MG-K10 at an initial dose of 600 mg, followed by 300 mg once every 4 weeks, for a total of 7 doses during the maintenance treatment phase. All participants use mometasone furoate nasal spray at 200 μg daily as background therapy from the run-in period through study completion at Week 60.
Biological: MG-K10 · Drug: Placebo · Drug: Mometasone Furoate Nasal Spray
MG-K10 humanized monoclonal antibody injection administered via subcutaneous injection. During the first 24 weeks, the MG-K10 group receives an initial dose of 600 mg, followed by 300 mg every 4 weeks, for a total of 6 doses. At Week 24, the MG-K10 group receives 300 mg plus matching placebo, while the original placebo group receives an initial dose of 600 mg; thereafter, both groups receive 300 mg every 4 weeks, for a total of 7 doses during the maintenance treatment period.
Placebo matching MG-K10 administered via subcutaneous injection. During the first 24 weeks, the placebo group receives an initial dose of 4.0 mL, followed by 2.0 mL every 4 weeks, for a total of 6 doses. At Week 24, the MG-K10 group concurrently receives matching placebo 2.0 mL to maintain blinding.
Mometasone furoate nasal spray administered as background therapy for all participants at 200 μg daily from the run-in period through study completion at Week 60: 2 actuations per nostril once daily, 50 μg per actuation.
Change From Baseline in Bilateral Nasal Polyp Score (NPS)
Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size. A negative change from baseline indicates improvement.
Time frame: Baseline and Week 24
Change From Baseline in Nasal Congestion Score (NCS)
Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement.
Time frame: Baseline and Week 24
Change From Baseline in Bilateral Nasal Polyp Score (NPS) (Other Than Week 24)
Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size. A negative change from baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 28, 32, 40, 48, 52, and 60
Percentage of Participants With at Least a 1-Point Improvement From Baseline in Nasal Polyp Score (NPS)
Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size; a negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 1 point from baseline in NPS is calculated at each designated visit.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60
Percentage of Participants With at Least a 2-Point Improvement From Baseline in Nasal Polyp Score (NPS)
Nasal endoscopy with central reading evaluates bilateral nasal polyp size. Each nostril is scored from 0 to 4, yielding a total bilateral Nasal Polyp Score (NPS) ranging from 0 to 8, where higher scores indicate larger polyp size; a negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 2 points from baseline in NPS is calculated at each designated visit.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60
Change From Baseline in Nasal Congestion Score (NCS) (Other Than Week 24)
Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 28, 32, 40, 48, 52, and 60
Percentage of Participants With at Least a 1-Point Improvement From Baseline in Nasal Congestion Score (NCS)
Participants record their previous day's nasal congestion severity daily on a scale from 0 to 3, where higher scores indicate more severe nasal congestion. The Nasal Congestion Score (NCS) baseline is typically calculated as the mean of the 7 days prior to randomization; if fewer than 4 days are recorded within those 7 days, the mean of the most recent 4 days of records prior to randomization is used. Post-baseline scores are calculated as the mean of at least 8 daily records within the 14 days prior to the scheduled visit. A negative change relative to baseline indicates improvement. The percentage of participants with a reduction of at least 1 point from baseline in NCS is calculated at each designated visit.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60
Change From Baseline in Total Symptom Score (TSS)
Total Symptom Score (TSS) comprises three items: nasal congestion, loss of smell, and rhinorrhea; scores for anterior rhinorrhea and posterior rhinorrhea are averaged first. Each item is scored 0-3, with a total score of 0-9, where higher scores indicate more severe symptoms. Baseline is the mean of the week prior to randomization, and post-baseline is the mean of the two weeks prior to the visit. If fewer than 4 days are recorded within the 7 days prior to randomization, baseline is the mean of the most recent 4 recorded days prior to randomization; at least 8 days of records are required within the 14 days prior to a post-baseline visit. The Week 24 assessment is a prespecified key secondary endpoint.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60
Change From Baseline in Loss of Smell (Hyposmia/Anosmia) Score
Participants daily assess the severity of loss of smell for the previous day. This score is identical to the smell item in the Total Symptom Score (TSS), ranging from 0-3, where higher scores indicate more severe symptoms. Baseline is the mean of the week prior to randomization, and post-baseline is the mean of the two weeks prior to the visit. If fewer than 4 days are recorded within the 7 days prior to randomization, baseline is the mean of the most recent 4 recorded days prior to randomization; at least 8 days of records are required within the 14 days prior to a post-baseline visit. The Week 24 assessment is a prespecified key secondary endpoint.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60
Change From Baseline in University of Pennsylvania Smell Identification Test (UPSIT) Score
A 40-item odor identification test, the University of Pennsylvania Smell Identification Test (UPSIT) awards 1 point for each correctly identified odor, with a total score ranging from 0 to 40, where higher scores indicate better olfactory function. The Week 24 assessment is a prespecified key secondary endpoint.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60
Change From Baseline in Sinus Computed Tomography (CT) Lund-Mackay Score
Evaluated by central reading of sinus computed tomography (CT) scans. The bilateral Lund-Mackay score ranges from 0 to 24, where higher scores indicate more severe disease. Baseline values are based on central reading results of available CT scans prior to randomization/first dose that meet protocol quality and time-window requirements; if a qualified CT scan was completed during the screening or run-in period, repeated scanning at baseline is not required. The Week 24 assessment is a prespecified key secondary endpoint.
Time frame: Baseline (prior to first dose) and Weeks 24 and 52
Percentage of Participants Receiving Rescue Treatment
Calculates the percentage of participants receiving rescue treatment with systemic corticosteroids or nasal polyp surgery due to worsening signs or symptoms of chronic rhinosinusitis with nasal polyps (CRSwNP). The cumulative percentage through Week 24 is a prespecified key secondary endpoint; rescue treatments during the subsequent treatment period and safety follow-up period are also recorded.
Time frame: Baseline up to Week 24, and Baseline up to Week 60
Time to First Improvement of at Least 1 Point From Baseline in Nasal Polyp Score (NPS)
Time from baseline to the first occurrence of a reduction of at least 1 point from baseline in bilateral Nasal Polyp Score (NPS) observed at scheduled nasal endoscopy assessment visits.
Time frame: Baseline up to Week 60; assessment visits are at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60
Time to First Rescue Treatment
Time from baseline to the first administration of rescue treatment with systemic corticosteroids or nasal polyp surgery due to worsening of chronic rhinosinusitis with nasal polyps (CRSwNP).
Time frame: Baseline up to Week 60
Change From Baseline in 22-Item Sino-Nasal Outcome Test (SNOT-22) Score
The 22-item Sino-Nasal Outcome Test (SNOT-22) is a participant-reported questionnaire with 22 items scored from 0 to 5 each, yielding a total score of 0 to 110, where higher scores indicate greater symptom severity and quality-of-life impact. The recall period covers the past 2 weeks. The Week 24 assessment is a prespecified key secondary endpoint.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60
Change From Baseline in EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS) Score
The EuroQol Visual Analogue Scale (EQ VAS) component of the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire records participant-rated health status on a scale from 0 to 100, where 0 represents the worst health imaginable and 100 represents the best health imaginable.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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