A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (NCT06639295) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
China243 participantsStarted 2024-11-22
Plain-language summary
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Female and male patients aged ≥18 and ≤ 75 years at the time of screening.
* Bilateral CRSwNP.
* Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity
* Nasal Congestion Score of 2 at screening and a weekly average severity of 2 at time of randomization.
* Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF.
Exclusion Criteria:
* Patients with other nasal diseases or symptoms.
* Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening.
* Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
* History of cancer.
* Known or suspected history of immunosuppression.
* Known with allergic or intolerant to mometasone furoate spray or 611/ placebo
What they're measuring
1
Change From Baseline at Week 24 in Bilateral Nasal Polyp Score (NPS)
Timeframe: 24 weeks
2
Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score (NCS)