Phase 3 Chronic Rhinosinusitis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent before the trial begins, showing they understand its goals, procedures, and possible side effects.
• People aged 18 to 75 years (inclusive) at the time of signing consent, of any gender.
• People who have been diagnosed with chronic sinusitis with nasal polyps in both nostrils (bilateral CRSwNP), meeting specific Chinese clinical guidelines from 2018.
• People who have had at least one course of steroid tablets or injections within the past 2 years and still have nasal polyps in both nostrils; OR who cannot take systemic steroids due to a medical reason or intolerance; OR who had nasal polyp surgery more than 6 months before the screening visit.
• People whose nasal polyps score at least 5 out of 8 on a standardised scale (with at least 2 points in each nostril), as measured by a nasal camera examination at screening and at the start of the trial.
• People whose nasal blockage is rated at 2 or higher on a standard scale, measured on average over the day at screening and over the week at the start of the trial.
• People who have had ongoing runny nose and/or a reduced or lost sense of smell for more than 8 weeks before screening.
• People whose quality-of-life score on a standard 22-question sinus and nose questionnaire (SNOT-22) is 30 or higher at both screening and the start of the trial.
• People who have been using a steroid nasal spray at a stable dose for more than 4 weeks before screening (those not already using mometasone furoate nasal spray would need to switch to that specific spray during the study).
• People with asthma as well, provided their asthma symptoms have been stable for at least 4 weeks before screening and any asthma medications have been at the same dose for at least 4 weeks.
• People who, during a lead-in period before the trial formally starts, used their mometasone furoate nasal spray on more than 70% of required days and completed their daily symptom diary on more than 70% of days.
• People (or people whose partners could become pregnant) who agree to use effective non-hormonal contraception from the time of consent until 6 months after the final dose.

Who may not be able to join:

• People with a severely crooked nasal septum that blocks at least one nostril, or a hole (perforation) in the nasal septum.
• People who have had an acute sinus infection, nasal infection, or upper respiratory infection within 2 weeks before screening, or during the screening or lead-in period.
• People with rhinitis caused by overuse of decongestant nasal sprays (rhinitis medicamentosa).
• People diagnosed with certain specific conditions including eosinophilic granulomatosis with polyangiitis (EGPA), granulomatosis with polyangiitis (GPA), Young's syndrome, Kartagener's syndrome, other conditions affecting the tiny hairs (cilia) lining the airways, or cystic fibrosis.
• People where imaging suggests or confirms a fungal sinus infection.
• People who have had previous nasal surgery that changed the structure of the side walls of the nose in a way that makes accurate nasal polyp scoring impossible.
• People with cancer or non-cancerous growths inside the nose (such as papillomas or haemangiomas).
• People who have had any nasal or sinus surgery (including polyp removal) within 6 months before screening.
• People who have had uncontrolled nosebleeds within 2 months before screening.
• People who regularly use nasal or oral decongestants (other than briefly during nasal camera examinations).
• People who have taken immune-suppressing medications (such as cyclophosphamide, cyclosporine, methotrexate, or tacrolimus, among others) within 8 weeks or 5 half-lives before screening, whichever period is longer.
• People who have received any monoclonal antibody treatments (such as dupilumab, omalizumab, mepolizumab, benralizumab, or similar medicines) within 8 weeks or 5 half-lives before screening, whichever period is longer.
• People who have used short- or medium-acting steroid tablets, injections, or drips within 4 weeks before screening, or long-acting steroid injections (such as triamcinolone) within 6 weeks before screening, or who plan to use these during the study; this also includes certain traditional Chinese medicine preparations for sinusitis.
• People who have used corticosteroid-releasing nasal stents within 6 months before screening.
• People who have received immunoglobulins or blood products within 28 days before screening.
• People who have received live vaccines within 28 days before screening, or who plan to receive them during the study.
• People who received allergen immunotherapy (desensitisation treatment) within 6 months before screening, unless it was started more than 3 months before screening, has been at a stable dose for at least 1 month, and no dose changes are planned during the study.
• People who have taken part in another clinical drug or medical device trial within 3 months before screening.
• People who used antihistamine nasal sprays (such as olopatadine, azelastine, or levocabastine nasal sprays) in the first 3 days of the trial (confirm with trial site).
• People with a history of active tuberculosis in the lungs within the past 12 months.
• People who have had an infection in the past 14 days that required antibiotic, antiviral, antifungal, or antiparasitic treatment.
• People diagnosed with a parasitic worm (helminth) infection in the past 6 months who did not receive standard treatment or whose treatment did not work.
• People with a known or suspected history of a weakened or disordered immune system, including those who have had serious opportunistic infections (such as histoplasmosis, aspergillosis, or pneumocystosis), even if fully recovered; or people who have had unusually frequent, recurring, or prolonged infections, as assessed by the study doctor.
• People whose lung function test (FEV1) result during screening is 50% or less of what would be expected for a healthy person of the same age and size.
• People with asthma who have had an asthma flare-up (requiring steroid treatment, an emergency visit, or hospitalisation) within the 90 days before screening, or who are currently using high-dose inhaled steroids (above the equivalent of 1000 micrograms of fluticasone per day).
• People with asthma who are using leukotriene-blocking medications (such as montelukast) unless they have been on a stable dose continuously for at least 30 days before the start of the trial.
• People with other significant active lung diseases (such as active tuberculosis, lung cancer, bronchiectasis, pulmonary fibrosis, or pulmonary hypertension) that the study doctor considers could significantly affect the study.
• People who have had part of a lung removed or have had lung volume reduction surgery within 12 months before the study starts.
• People with significant heart or cardiovascular conditions — including unstable heart disease, heart failure, uncontrolled high blood pressure, recent heart attack, serious heart rhythm problems, or abnormal electrical heart activity — where the study doctor considers participation could be unsafe or affect results.
• People with very difficult venous access (veins hard to find for blood draws) or a history of fainting in response to needles or blood.
• People with a current active cancer, or a past history of cancer, unless the cancer was a limited skin cancer or cervical pre-cancer that was fully treated more than 12 months ago, or another cancer that was fully treated at least 5 years ago.
• People with active autoimmune diseases (such as Graves' disease, lupus, inflammatory bowel disease, rheumatoid arthritis, psoriasis, or multiple sclerosis, among others).
• People who test positive for hepatitis B surface antigen (HBsAg) during screening.
• People who test positive for a hepatitis B core antibody (HBcAb) and also have detectable hepatitis B virus DNA in their blood.
• People who test positive for both hepatitis C antibody and hepatitis C virus RNA, or who have previously been treated for hepatitis C.
• People who test positive for syphilis antibodies, unless a follow-up test is negative and the study doctor considers the infection to have been previously cured.
• People who test positive for HIV.
• People with abnormal blood test results, specifically: white blood cell count below 3.5 × 10⁹/L; liver enzyme levels (AST or ALT) more than 2.5 times the upper limit of normal; total bilirubin more than twice the upper limit of normal; or creatinine (a kidney marker) more than 1.5 times the upper limit of normal.
• People with any other clinically significant abnormal findings from physical examination, vital signs, heart trace (ECG), or blood and urine tests during the lead-in period, that the study doctor considers could put the person at risk, affect results, or prevent completion of the study.
• People who are pregnant or breastfeeding.
• People who currently smoke or who stopped smoking less than 6 months before screening.
• People who have regularly consumed more than 14 units of alcohol per week (for women) or more than 21 units per week (for men) in the past 6 months, who are unable to abstain during the trial, or who return a positive breath alcohol test.
• People with a history of drug misuse or abuse within the past 2 years, or a positive drug screening result.
• People with a known allergy or sensitivity to any ingredient in mometasone furoate nasal spray (Nasonex®) or the trial injection (TQC2731).
• People with a history of a serious whole-body allergic reaction to any biological medicine (reactions only at the injection site do not apply).
• People whose history suggests poor adherence to treatment or study procedures, and who the study doctor considers unlikely to complete the study.
• People with any medical or mental health condition that, in the study doctor's or sponsor's medical reviewer's judgement, could affect safety, prevent completion of all study visits, or make it difficult to interpret the results — including but not limited to significant heart, digestive, liver, kidney, nerve, muscle, bone, infectious, hormonal, blood, or psychiatric conditions, or major physical disabilities.

Important: Always verify eligibility with the trial site directly before applying.