Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP)
Conditions
Interventions
single arm :QX005N 600 mg Q4W
Sponsors
Beijing Tongren Hospital, CMU
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients voluntarily signed an informed consent (ICF) and participated in the clinical trial after fully understanding the purpose, characteristics, methods and possible adverse reactions of the trial, and were able to comply with the requirements of the ICF and the protocol to complete the study; 2)Male or female =18 years of age at visit 1; 3) Patients participating in the previous study (study number:QX005NB-01) received the prescribed treatment, and completed the end-of-study visit according to the requirements of the previous study protocol. If the patient of the previous study interrupts the treatment but does not withdraw early due to irresistible factors (such as being injured by a dog), and has received at least 6 doses of the IMP, the investigator and the sponsor must comprehensively judge their eligibility for enrollment ; 4) After the assessment by the investigators, the patient willing and able to comply with clinic visits and study-related procedures as per protocol 5) Patients and their partners has no intent to become pregnant and voluntarily takes effective contraceptive measures during the study and within 6 months after the last administration. 6)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 stable dose during the study(Note: For patients who used INCS products other than MFNS before screening, they must switch to MFNS treatment at V1, and the 4-week treatment period of patients receiving MFNS before enrollment can be regarded as the run-in period. );
Exclusion criteria
Exclusion criteria: 1) The patient had an SAE related to QX005N injection in the previous study, or AE related to QX005N injection led to the termination of the treatment of QX005N injection, and after discussion between the investigator and the sponsor, it was judged that the patient was not suitable for continuing to receive QX005N injection; 2) Other situations that lead to the termination of the IMP(such as poor compliance of the patient in the previous study), the investigator judges that the patient is not suitable to continue to be included in this study; 3) Patient who has previously been treated in Dupilumab or other drugs targeting IL-4 or IL-13(excluding QX005N injection). 4) Patient who has taken: -Systemic corticosteroid (SCS) therapy within 1week or 5 half-lives(whichever is longer) prior to V1 or a plan to begin therapy during the study. -Biologic therapy/systemic immunosuppressant(eg,Methotrexate, Cyclosporine, Mycophenolate, Tasilolimus, Penicillamine, Sulfadiazine, Hydroxychloroquine, Azathioprine, Cyclophosphamide, etc.) to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 8 weeks before V2 or 5 half-lives, whichever is longer. -Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to V1 or 5 half-lives, whichever is longer. -other monoclonal antibody drugs or participated in clinical trials of such drugs within 60 days before V1 or 5 half-lives, whichever is longer. -Patients who are receiving leukotriene antagonists/modifiers at V1 unless they are on a continuous treatment for at least 30 days prior to V1. -Initiation of allergen immunotherapy within 3 months prior to V1 or a plan to begin therapy during the study. 5) Patients who have undergone any nasal surgery that has the impact on the efficacy evaluation within 6 months before V1. 6) Patients with diseases or symptoms that affect the efficacy evaluation of the IMP, such as: -Nasal septal deviation that would occlude at least one nostril. -Acute sinusitis, nasal infection or upper respiratory infection within 2 weeks prior to V1 or during the screening period. 7) CT scan or symptoms indicading allergic fungal sinusitis. 8) Patients with asthma will be excluded if they meet any of the following conditions: -Patients with forced expiratory volume (FEV1) 60% or less of predicted normal. -Exacerbation of asthma requiring systemic steroid therapy (oral and/or parenteral)or hospitalization (>24 hours) within 3 months prior to V1; -Receiving Fluticasone or its equivalent inhaled corticosteroid at a dose >1000 µg; 9) Patients who are unwilling to record the assessment of daily symptoms and maintain a stable dose of MFNS during run-in period, or those who are judged to be in poor compliance at V2. 10)Allergy or intolerance to the ingredients of mometasone furoate nasal spray (MFNS) or QX005N injection; 11) Pregnant or intent to become pregnant during the study, or breast-feeding women. 12) Women of childbearing potential (WOCBP) (pre-menopausal female biologically capable of becoming pregnant) who do not fulfill: -confirmed negative serum beta-human chorionic gonadotrophin (ß-hCG) tests at V1 and before the first adminisation of IMP. AND either: -Agree to take effective contraceptive method during the study and within 6 months after the last adminisation; OR -Female sterilization (eg, tubal occlusion, hysterectomy or bilateral salpi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events Related to QX005N Injection ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bilateral nasal endoscopic polyp score;Lund -- Mackay score was scanned by sinus CT;22 nasal and sinuses outcome tests;Disease-specific symptom daily score and total symptom score;Visual analogue scale for sinusitis;University of Pennsylvania smell recognition test; | — |
Countries
China
Contacts
Public ContactZhang Luo
Beijing Tongren Hospital, Capital Medical University
Outcome results
None listed