AzTrials
AzTrials

Chronic Rhinosinusitis With Nasal PolypsPhase 3NCT07903194

A Study to Evaluate the Efficacy and Safety of MG-K10 in Adults With Chronic Rhinosinusitis With Nasal Polyps

A Phase 3 study testing MG-K10 and Mometasone Furoate Nasal Spray in people with Chronic Rhinosinusitis With Nasal Polyps, run by Shanghai Mabgeek Biotech.Co.Ltd.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Rhinosinusitis With Nasal Polyps
What is being tested?
MG-K10 and Mometasone Furoate Nasal Spray
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
No sites listed yet
Study dates
27 Oct 2026to 29 Aug 2028
Phase
Phase 3
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

  • Capable of understanding the nature of the study and voluntarily signing the informed consent form (ICF).
  • Aged ≥18 and ≤75 years (inclusive) at the time of signing the ICF, male or female.
  • Confirmed diagnosis of bilateral CRSwNP meeting the diagnostic criteria of the Chinese Guidelines for the Diagnosis and Treatment of Chronic Rhinosinusitis (2024).
  • Continuous concurrent presence of the following symptoms for ≥4 weeks prior to the screening period:
  • Nasal congestion;
  • Any one of the other symptoms: sticky or mucopurulent nasal discharge, facial pain/pressure/fullness, hyposmia or anosmia.
Show all 12Show fewer
  • Bilateral Nasal Polyp Score (NPS) ≥5 points (out of a total of 8 points) at screening and prior to randomization, with a score of ≥2 points in each nasal cavity (based on central reading results).
  • Participant-reported moderate to severe nasal congestion at screening and prior to randomization: Nasal Congestion Score (NCS) of 2 or 3 points at the screening visit (V1); weekly average NCS ≥2 points prior to randomization (baseline).
  • Received systemic corticosteroids (SCS) within 2 years prior to screening but still has bilateral CRSwNP, AND/OR has contraindications to or intolerance of SCS therapy, AND/OR underwent nasal polyp surgery >6 months prior to screening but still has bilateral CRSwNP.
  • Received a stable dose of intranasal corticosteroids (INCS) for at least 4 weeks prior to screening, and received mometasone furoate nasal spray (MFNS) for at least 2 weeks prior to randomization.
  • MFNS dosing compliance ≥80% during the run-in period based on daily diary (Compliance = actual administered dose / planned total dose * 100%, where planned total dose = number of dosing days * 2 * 2 * 50 μg, and actual administered dose = number of actuations * 50 μg).
  • Female participants of childbearing potential and male participants (and their female partners) must have no plans for childbearing, sperm donation, or egg donation from screening until at least 6 months after the last dose of study drug. During this period, female participants of childbearing potential and male participants whose partners are women of childbearing potential must use highly effective contraception. Male participants with azoospermia (resulting from vasectomy or other underlying conditions) and their partners are not required to take contraceptive measures.

Who cannot join

  • Receipt of the following treatments prior to screening:
  • Treatment with any systemic monoclonal antibody or biologic agent within 3 months or 5 half-lives (whichever is longer) prior to baseline, such as IL-4Rα monoclonal antibodies (dupilumab, stapokibart, etc.), IL-5/IL-5Rα pathway drugs (mepolizumab, benralizumab, depemokimab, etc.), anti-IgE monoclonal antibodies (omalizumab, etc.), anti-TSLP/TSLPR pathway drugs (tezepelumab, etc.), or other biologics evaluated by the investigator that may affect the efficacy evaluation of CRSwNP;
  • Treatment with systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 4 weeks or 5 half-lives (whichever is longer) prior to baseline;
  • Initiation of leukotriene receptor antagonist (LTRA) treatment within 4 weeks prior to baseline (except for participants who have been on a stable dose of LTRA for at least 4 weeks prior to randomization);
  • Initiation of allergen-specific immunotherapy (desensitization therapy) within 3 months prior to baseline, or planned initiation during the study period;
  • Receipt of short- or medium-acting SCS (including oral, intravenous, and intramuscular corticosteroids) or Traditional Chinese Medicine (TCM, including systemic and topical TCM preparations) for chronic rhinosinusitis within 4 weeks prior to screening; or receipt of long-acting SCS (e.g., triamcinolone acetonide injection) within 6 weeks prior to screening; or planned treatment with the above medications during the study period;
Show all 41Show fewer
  • Participation in other drug clinical studies within 3 months or 5 half-lives (whichever is longer) prior to randomization, or planned participation in other drug clinical studies during the study period;
  • Prior use of interleukin-4 receptor alpha subunit (IL-4Rα) monoclonal antibody drugs with development of drug resistance or drug-related serious AEs as judged by the investigator;
  • Prior participation in an MG-K10 clinical trial and receipt of MG-K10 study drug.
  • Receipt of systemic (oral or intravenous) antibacterial, antiviral, or antifungal therapy within 4 weeks prior to randomization; or current presence of any symptoms, signs, or laboratory abnormalities suggestive of potential acute or subacute infection (such as fever, cough, urinary urgency, dysuria, abdominal pain, diarrhea, infectious skin wounds, etc.).
  • Confirmed active parasitic infection; or suspected parasitic infection or high risk of infection, unless active infection has been ruled out prior to randomization by clinical assessment and (if necessary) laboratory evaluation.
  • Patients with comorbid asthma who meet any of the following conditions will be excluded:
  • Asthma exacerbation within 3 months prior to screening requiring systemic (oral and/or parenteral) steroid therapy or hospitalization (>24 hours);
  • For asthma participants receiving inhaled corticosteroids (ICS), treatment with a stable dose of ICS for <4 weeks prior to screening, or an ICS daily dose of >2000 μg fluticasone propionate or equivalent of another ICS [participants who have been on a stable dose of ≤2000 μg fluticasone propionate or equivalent of another ICS for ≥4 weeks prior to screening and assessed by the investigator as capable of maintaining the current ICS regimen during the double-blind treatment period are eligible].
  • Forced expiratory volume in 1 second (FEV1) ≤50% of predicted value at screening.
  • Comorbid with other nasal conditions or symptoms, such as:
  • Nasal surgery within 6 months prior to screening (including polypectomy, except for nasal biopsy solely for diagnostic purposes); or participants with prior surgery that altered nasal anatomy resulting in an inability to assess NPS;
  • Unilateral antrochoanal polyp;
  • Severe nasal septal deviation causing obstruction of at least one nostril;
  • Cystic fibrosis;
  • Persistent rhinitis medicamentosa;
  • Acute sinusitis, nasal infection, or acute upper respiratory tract infection at screening or within 2 weeks prior to screening;
  • Symptomatic or CT scan suggestive of allergic fungal rhinosinusitis;
  • Malignant or benign tumors of the nasal cavity.
  • Accompanied by eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener's granulomatosis), Young's syndrome, Kartagener's syndrome, or other ciliary dyskinesia syndromes.
  • Known hypersensitivity to MFNS, anti-IL-4Rα monoclonal antibody drugs, or any components of MG-K10.
  • Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematologic, neurological, or psychiatric diseases that are unstable or poorly controlled and deemed clinically significant by the investigator, such as: life expectancy <3 months; uncontrolled diabetes mellitus (glycated hemoglobin [HbA1c] ≥9%); cardiovascular disease [such as New York Heart Association (NYHA) Class ≥III heart failure]; severe renal disease (such as patients receiving dialysis); hepatobiliary disease (such as Child-Pugh Class B or C); neurological disease (such as demyelinating disease); active autoimmune disease (such as systemic lupus erythematosus, inflammatory bowel disease, and rheumatoid arthritis), etc. "Clinically significant" is defined as the investigator determining that participation would pose a safety risk to the participant, or that worsening of the disease/condition during the study would affect efficacy or safety analyses.
  • Planned major surgery during the study period, including inpatient surgery and day-case/outpatient surgery.
  • Any of the following infectious disease screening criteria met at screening:
  • Evidence of active tuberculosis (TB), or past history of active TB without appropriate documented treatment; chest X-ray (posteroanterior and lateral) or chest CT within 3 months prior to screening or during the screening period indicating active TB infection;
  • Active hepatitis during screening, or positive hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody (HBcAb) with positive hepatitis B virus deoxyribonucleic acid (HBV DNA), or positive hepatitis C virus (HCV) antibody with positive HCV ribonucleic acid (HCV RNA);
  • History of human immunodeficiency virus (HIV) infection, or positive HIV antibody at screening;
  • Positive Treponema pallidum antibody (TP-Ab) at screening, except for those with a negative rapid plasma reagin (RPR) test or toluidine red unheated serum test (TRUST).
  • History of malignancy within 5 years (Note: 1. Patients with cervical carcinoma in situ that has been resected with no evidence of recurrence or metastasis for at least 3 years may participate in this study. 2. Patients with basal cell carcinoma or squamous cell carcinoma that has been completely resected with no recurrence for at least 3 years may participate in this study).
  • Any of the following laboratory criteria met at screening or prior to randomization and judged by the investigator as unsuitable for inclusion: severe hepatic impairment, such as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 × upper limit of normal (ULN), or total bilirubin >2 × ULN; severe renal impairment, such as serum creatinine >2 × ULN judged clinically significant by the investigator; complete blood count: platelet count <75 × 10^9/L, neutrophil count <1.2 × 10^9/L; or other clinically significant laboratory abnormalities judged by the investigator as unsuitable for enrollment.
  • Abnormal 12-lead electrocardiogram (ECG) at screening considered clinically significant by the investigator or sponsor and likely to pose an unacceptable risk to the patient's participation in the study (e.g., Fridericia's corrected QT interval [QTcF] >500 msec).
  • Receipt of a live vaccine within 12 weeks prior to screening, or planned vaccination with a live (attenuated) vaccine during the study period.
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study period.
  • History of illicit drug use, substance abuse, or alcohol abuse (defined as consuming >14 units of alcohol per week [1 unit = 360 mL of beer, 45 mL of spirits with 40% alcohol content, or 150 mL of wine]).
  • Patients with ocular diseases judged by the investigator as unsuitable for study participation, such as a history of atopic keratoconjunctivitis involving the cornea within 6 months prior to screening; if the investigator cannot make a determination, an ophthalmologist must be consulted for diagnosis.
  • Any other medical or non-medical condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Project Manager contact

+86-021-51371305

lipeng.liu@mabgeek.com

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Phase III Clinical Study Evaluating the Efficacy and Safety of MG-K10 Humanized Monoclonal Antibody Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps

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.

Being tested
MG-K10, Placebo, Mometasone Furoate Nasal Spray

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MG-K10Biological

    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.

  • PlaceboDrug

    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 SprayDrug

    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.

Study groups in NCT07903194
Study groupRoleWhat they receive
MG-K10ExperimentalExperimental 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.
Receives: Biological: MG-K10; Drug: Placebo; Drug: Mometasone Furoate Nasal Spray
PlaceboPlacebo comparatorPlacebo 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.
Receives: Biological: MG-K10; Drug: Placebo; Drug: Mometasone Furoate Nasal Spray

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and Week 24

  2. 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.

    Measured: Baseline and Week 24

Secondary outcomes (14)

  1. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 28, 32, 40, 48, 52, and 60

  2. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60

  3. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60

  4. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 28, 32, 40, 48, 52, and 60

  5. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60

  6. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60

  7. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60

  8. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60

  9. 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.

    Measured: Baseline (prior to first dose) and Weeks 24 and 52

  10. 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.

    Measured: Baseline up to Week 24, and Baseline up to Week 60

  11. 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.

    Measured: Baseline up to Week 60; assessment visits are at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 40, 48, 52, and 60

  12. 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).

    Measured: Baseline up to Week 60

  13. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60

  14. 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.

    Measured: Baseline and Weeks 4, 8, 12, 16, 20, 24, 32, 40, 48, 52, and 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2026
  2. Study start27 Oct 2026 (estimated)
  3. Primary completion21 Dec 2027 (estimated)
  4. Study completion29 Aug 2028 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, 1:1 randomized, parallel-group study. The first 24 weeks compare MG-K10 with placebo; starting at Week 24, participants in the original placebo group switch to MG-K10, and both groups remain blinded through Week 52, with follow-up through Week 60. Stratified by presence of comorbid asthma, prior history of nasal polyp surgery, and prespecified eosinophil level. At least 60% of participants must meet the prespecified eosinophil criteria: screening peripheral blood eosinophil percentage ≥ 6.9% (without asthma) or ≥ 3.7% (with asthma), or nasal polyp tissue eosinophil count ≥ 55 per high-power field or percentage ≥ 27%.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07903194
Sponsor's protocol ID
MG-K10-CRSwNP-002
Status last verified
Oct 2026
First submitted
14 Oct 2026
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MG-K10 and Mometasone Furoate Nasal Spray in people with Chronic Rhinosinusitis With Nasal Polyps, run by Shanghai Mabgeek Biotech.Co.Ltd.

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 12 inclusion and 41 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 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Clinical Project Manager (+86-021-51371305, lipeng.liu@mabgeek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Bilateral Nasal Polyp Score (NPS) (time frame: Baseline and Week 24). 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?

On the ClinicalTrials.gov record for NCT07903194.

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 29 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in