Phase 2 Chronic Rhinosinusitis Trial, Recruiting

Written by an AI model from the 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 already been enrolled in the related TQH2722 clinical study (study number TQH2722-II-02) for chronic sinusitis with or without nasal polyps, and who either completed that study as planned, or left early for reasons unrelated to a drug side effect — and where the reason for leaving early no longer applies (as determined by the research team)
• People aged 18 to 75 years old (inclusive), of any gender
• People who have been using a stable dose of a nasal steroid spray for more than 4 weeks before the screening visit, and who are willing to switch to a specific nasal spray called Mometasone furoate (MFNS) during the study if they are currently using a different one
• People who agree to avoid pregnancy for 6 months from signing the consent form until after the last dose, and who agree to use effective non-hormonal contraception with any partner who could become pregnant
• People must sign an informed consent form showing they understand the trial's purpose, process, and possible side effects before taking part

Who may not be able to join:

• People who experienced a serious side effect related to TQH2722 during the main study, or whose TQH2722 treatment was stopped because of a side effect, and who the research team has determined should not continue TQH2722 treatment
• People whose compliance (following study rules) was poor during the main study, and who the research team believes are unlikely to complete this continuation study
• People who developed a severe or poorly controlled ongoing health condition during the main study (such as an asthma flare-up requiring changes to regular medication) and who the lead investigator considers unfit to continue
• People whose blood test results at screening show certain liver or kidney values outside acceptable ranges — specifically, liver enzyme levels (ALT or AST) more than 2.5 times the upper limit of normal, total bilirubin more than 2 times the upper limit of normal (with a specific exception for a condition called Gilbert syndrome), or creatinine more than 1.5 times the upper limit of normal
• People with an unstable medical condition in any body system — including the heart, digestive system, liver, kidneys, nerves, muscles, hormones, blood, or mental health — that the investigator believes could affect safety, study results, or the person's ability to complete the study (for example, heart disease, uncontrolled high blood pressure, uncontrolled high blood sugar, or stroke-related conditions)
• People with an active autoimmune disease, including conditions such as Hashimoto's thyroiditis, Graves' disease, inflammatory bowel disease, lupus, multiple sclerosis, psoriasis, or rheumatoid arthritis
• People with a known or suspected weakened immune system, including those with a history of serious infections that are uncommon in healthy people (such as histoplasmosis or aspergillosis), even if those infections have cleared up
• People with an active cancer or a history of cancer — with exceptions for people who completed successful treatment for certain limited skin cancers or cervical pre-cancer at least 12 months before the first visit, or other cancers where successful treatment was completed at least 5 years before the first visit
• People who had active tuberculosis (TB) in the lungs within the 12 months before screening
• People who test positive for active hepatitis B, active hepatitis C, HIV, or syphilis at screening (a past syphilis infection that has been fully treated may be considered acceptable — confirm with trial site)
• People diagnosed with a parasitic worm (helminth) infection within 6 months before screening who have not successfully completed standard treatment
• People who have had sinus or nasal surgery within 6 months before screening
• People who received a monoclonal antibody therapy within 8 weeks (or 5 half-lives, whichever is longer) before screening
• People who received immune-suppressing medications (such as cyclophosphamide, cyclosporine, methotrexate, or similar drugs) within 8 weeks (or 5 half-lives, whichever is longer) before screening
• People who used certain other non-biological treatments within 8 weeks (or 5 half-lives, whichever is longer) before screening (confirm with trial site)
• People who received intravenous immunoglobulin (IVIG) therapy or plasma exchange within 30 days before screening
• People who started leukotriene modifier treatment close to screening — those who have been on a stable dose of this type of medication for at least 30 days before screening may still be considered eligible (confirm with trial site)
• People who started allergy immunotherapy (desensitisation treatment) within 3 months before screening, or who plan to start or change the dose of such therapy during the study
• People who received a live attenuated vaccine within 4 weeks before screening, or who plan to receive one during the study
• People who had an active infection requiring treatment with antibiotics, antivirals, antiparasitic, or antifungal medicines in the 4 weeks before screening (screening may be possible after recovery, provided at least 2 weeks have passed since finishing antibiotics)
• People with asthma who have a lung function test (FEV1) at or below 50% of the expected normal value, or who were hospitalised for an asthma attack for more than 24 hours in the 90 days before screening, or who are using high daily doses of certain inhaled steroids (fluticasone or equivalent above 1000 mcg per day)
• People with asthma who started inhaled corticosteroid treatment within 4 weeks before screening, unless they have been on a stable dose for at least 4 weeks and that dose can be maintained throughout the study
• People with certain nasal or sinus conditions that would prevent proper assessment, including: a significantly deviated nasal septum blocking at least one nostril; ongoing medication-caused nasal congestion; specific diagnosed conditions such as Churg-Strauss syndrome, Wegener's granuloma, Young's syndrome, Kartagener syndrome, other ciliary movement disorders, or cystic fibrosis; or imaging suggesting a fungal sinus infection
• People with nasal tumours, whether cancerous or non-cancerous (such as papillomas or haemangiomas)
• People who are unable to use the nasal spray MFNS, or who have an allergy or intolerance to Mometasone furoate nasal spray
• People with a history of a whole-body (systemic) allergic reaction to any biological medicine (not including local reactions at an injection site)
• People who are pregnant or breastfeeding
• People with alcohol, drug, or known medication dependence
• People whose compliance during the study the investigator believes will be insufficient to complete the study
• People with any medical or psychiatric condition that the investigator or sponsor considers to place the person at risk, or that would interfere with the study or the interpretation of results

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