Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)
Conditions
Interventions
Parallel group 1:QX005N 300 mg Q2W
Parallel group 2:QX005N 600 mg Q4W
Parallel group 3:Placebo Q2W
Sponsors
Beijing Tongren Hospital, CMU
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. The subject fully understands the purpose, nature, method and possible adverse reactions of the experiment, voluntarily acts as a subject, signs an informed consent form (ICF), and is able to comply with ICF and complete the study in accordance with protocol requirements; 2. At the time of signing the informed consent, the age of the subject shall be 18-70 years old (including the threshold value), no gender limit; 3. The diagnosis was confirmed as chronic sinusitis with bilateral nasal polyps, and the diagnostic criteria were in accordance with the Chinese Guidelines for the Diagnosis and Treatment of Chronic Sinusitis (2018); 4. During screening, bilateral endoscopic nasal polyp score (NPS) >=5 points (total score: 8), and unilateral NPS >=2 points; 5. Screening at least the following two symptoms: nasal congestion, sticky or sticky purulent nasal discharge, head and face swelling pain, reduced or loss of smell (one of the main symptoms of nasal congestion, sticky or sticky purulent nasal discharge must be one); 6. Bilateral CRSwNP is present despite the following treatment or conditions at screening, including: (1) Received systemic glucocorticoid (SCS) therapy within 2 years before screening; (2) And/or have contraindications to SCS treatment, or do not tolerate SCS treatment; (3) And/or surgical treatment for nasal polyps before 6 months prior to screening; 7. A stable dose of INCS should be used regularly for >=4 weeks before screening; 8. Patients who received Mometasone furoate nasal spray (MFNS) (200 µg/ day) for at least 28 days prior to randomization and were willing to maintain a steady dose for the duration of the study. Note: For patients using non-MFNs INCS alternatives prior to screening, investigators must switch patients to MFNS at V1; 9. Agree not to have a family plan during the trial period and for six months after the last dose and voluntarily use effective contraceptive methods.
Exclusion criteria
Exclusion criteria: 1. Allergic reaction to any excipients of test drug products or any other rabbit or human protein, or to immunoglobulin products; 2. Patients previously treated with Dupilumab or other IL4 or IL13 targets; 3. SNOT22 score =30 days (patients who had received steady dose continuous treatment for >=30 days before screening could be enrolled); (6) Allergen immunotherapy within 3 months prior to screening or planned during the study; 5. Patients who had received any nasal surgery within 6 months prior to screening; 6. Patients with co-existing diseases or symptoms that affect the assessment of efficacy in this study, such as: (1) Maxillary sinus choanal polyp; (2) A deviated nasal septum leading to obstruction of at least one nostril; (3) Acute sinusitis, nasal infection or upper respiratory tract infection occurred during or within 2 weeks before screening; (4) Persistent drug-induced rhinitis; (5) Known or suspected diagnosis of cystic fibrosis; (6) Chronic granulomatous diseases and granulomatous vasculitis, granulomatous polyvasculitis (Wegener's granuloma), eosinophilic polyvasculitis (ChurgStrauss syndrome), Young's syndrome, primary ciliary dyskinesia syndrome (Cartagne syndrome), or other ciliary dyskinesia syndromes; 7. CT scan or symptoms suggest allergic fungal sinusitis; 8. Patients with asthma will be excluded if they meet any of the following conditions: (1) Forced expiratory volume (FEV1) 24 hours); (3) Taking fluticasone or its equivalent inhaled corticosteroid at a dose greater than 1000 µg; 9. Patients who were unwilling to conduct daily symptom assessment of patient diaries and maintain steady dose of MFNS during the introduction period, or patients who judged poor compliance at V2; 10. Contraindications or other intolerances to the standard treatment (MFNS) prescribed for use in the study; 11. Patients during pregnancy, preparation for pregnancy and lactation; 12. Women of childbearing age cannot meet the following conditions: (1) Negative pregnancy tests during the screening period and before initial treatment wi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bilateral nasal endoscopic polyp score; | — |
Secondary
| Measure | Time frame |
|---|---|
| 22 nasal and sinuses outcome tests;Lund -- Mackay score was scanned by sinus CT;Disease-specific symptom daily score and total symptom score;Visual analogue scale for sinusitis;University of Pennsylvania smell recognition test;Anti-qx005n antibody in serum;Adverse events that occurred during treatment;The concentration of QX005 in serum; | — |
Countries
China
Contacts
Public ContactZhang Luo
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed