Phase 3 Chronic Rhinosinusitis Trial, Not Yet 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 aged between 18 and 75 years (inclusive) at the time of signing the consent form, of any gender
• People who have been diagnosed with chronic rhinosinusitis with nasal polyps (a long-term sinus condition with polyps) in both nostrils, meeting specific Chinese clinical guidelines (2024)
• People who meet at least one of the following: had steroid tablet/injection treatment for at least 3 consecutive days within the past 2 years; received a long-acting steroid injection (such as triamcinolone acetonide) within the past 2 years; had a medical reason they could not tolerate steroid treatment; or had nasal polyp surgery more than 6 months before the screening visit
• People who have had ongoing nasal blockage, plus at least one other symptom such as reduced sense of smell or a runny nose, lasting 8 weeks or more before the screening period
• People who have been using a nasal steroid spray at a stable dose for more than 4 weeks before screening, and who are willing to switch to a specific spray called Mometasone Furoate Nasal Spray (MFNS) if not already using it, and who used it as directed more than 70% of the time during the lead-in period
• People whose nasal polyp size, as measured by a camera examination of the nose, scores 5 or more out of 8 (with at least 2 points in each nostril) at both the screening visit and before being assigned to a treatment group
• People whose nasal congestion is rated at 2 or more (on a standard weekly average scale) at both the screening visit and before being assigned to a treatment group
• People who score 30 or more on a standard 22-question sinus symptom questionnaire (SNOT-22) at both the screening visit and before being assigned to a treatment group
• People of childbearing potential (male or female) who agree to use reliable contraception during the trial and for 3 months after the last dose; women of childbearing potential must not be breastfeeding and must have a negative pregnancy test at screening and before being assigned to a treatment group

Who may not be able to join:

• People with certain nasal structural conditions that would affect polyp measurement, such as a specific type of polyp called antrochoanal polyps, a hole in the nasal septum, severe nasal septum deviation blocking at least one nostril, or prior surgery that changed the structure of the nasal wall in a way that prevents proper assessment
• People with certain serious conditions (other than asthma) that could affect how the trial results are measured, including specific rare inflammatory conditions, bronchiectasis, pulmonary fibrosis, cystic fibrosis, conditions affecting the tiny hair-like structures in the airways, active sinus or upper respiratory infection at or within 2 weeks of screening, long-term overuse of nasal decongestant sprays, suspected or confirmed fungal sinusitis, or nasal/sinus tumours (benign or cancerous)
• People who have had uncontrolled nosebleeds within 2 months before screening
• People with serious uncontrolled ongoing health conditions that, in the trial doctor's opinion, could increase the risk of participating
• People with other active or significant breathing/lung conditions that could meaningfully affect the study, as judged by the trial doctor
• People with heart or cardiovascular disease where participation could affect their safety or the study results, as judged by the trial doctor
• People with a current or past cancer diagnosis of any type
• People who needed treatment with antibiotics, antivirals, antifungals, or antiparasitic medicines within 14 days before screening; or people diagnosed with a parasitic worm infection within 6 months before screening that has not been treated or has not responded to standard treatment
• People with a history of active tuberculosis (TB) within the past 12 months, or old TB that the trial doctor considers at high risk of returning
• People with known or suspected immune system problems, including a history of serious or unusual infections, removal of the spleen, or a primary immune deficiency condition
• People with asthma who also have any of the following: lung function (FEV1) at 50% or less of the expected normal level; an asthma flare-up within the past 90 days; currently using high-dose inhaled steroids (above 1000 micrograms fluticasone or equivalent per day); or who started inhaled steroids within 4 weeks before screening
• People who had nasal surgery within 6 months before screening
• People who received certain steroid medications (short- or medium-acting oral, intravenous, or injected steroids, or long-acting steroid injections) or certain traditional Chinese medicine preparations for their sinus condition within a specified period before screening; or who used steroid-releasing nasal stents within 6 months before screening
• People who received other biological medicines (such as IL-4Rα or anti-IgE antibody treatments) within 8 weeks or 5 half-lives (whichever is longer) before screening
• People who have previously been treated with an anti-TSLP monoclonal antibody
• People who received immune-suppressing medicines within 8 weeks or 5 half-lives (whichever is longer) before screening
• People who used leukotriene receptor antagonist medicines (a type of allergy/asthma medicine) within 4 weeks before the baseline visit
• People who regularly used nasal or oral decongestant medicines within 4 weeks before screening (except for short-term use during endoscopy procedures)
• People who started allergen desensitisation (immunotherapy) treatment within 3 months before the baseline visit, or who plan to start it during the study
• People who received immunoglobulin or blood products within 30 days before screening
• People who test positive for certain infectious diseases at screening, including active hepatitis B, hepatitis C (under specific conditions), active syphilis, or HIV
• People with significantly abnormal blood test results that the trial doctor considers a risk, or who have specific abnormal results for liver enzymes, bilirubin, white blood cell count, or kidney function
• People with significantly abnormal findings on physical examination, vital signs, or heart tracing (ECG) during screening that the trial doctor considers a risk
• People with a known allergy to Mometasone Furoate Nasal Spray (MFNS) or the study drug CM326; or a history of a severe whole-body allergic reaction to any biological medicine (not including local injection site reactions)
• People with a history of drug or alcohol misuse within 6 months before screening, as assessed by the trial doctor
• People who currently smoke, or who have a smoking history of 10 pack-years or more (confirm with trial site for exact calculation)
• People who received a live vaccine within 30 days before being assigned to a treatment group, or who plan to receive one during the study
• People who have used another investigational drug or medical device within 30 days or 5 half-lives (whichever is longer) before screening, or who are currently in or planning to join another clinical trial
• People whose ability to follow the study requirements is considered insufficient by the trial doctor (for example, due to a significant mental health history)
• People who, for any other medical or non-medical reason, the trial doctor considers unsuitable for participation

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