Clinical trial NCT06639295: A Study to Evaluate 611 in Patients with Chronic Rhinosinusitis with Nasal Polyps
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Sinusitis
Nasal Polyps
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Detailed description: The main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (MFNS) in reducing endoscopic nasal polyp score (NPS) and nasal congestion/obstruction score (NCS) severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (INCS) therapy in comparison to placebo

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline at Week 24 in Bilateral Nasal Polyp Score (NPS)
timeFrame: 24 weeks
measure: Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score (NCS)
timeFrame: 24 weeks
Secondary outcomes:
measure: Change From Baseline to the End of study in Lund Mackay Score
timeFrame: through study completion, an average of 13 months
measure: Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS)
timeFrame: through study completion, an average of 13 months
measure: Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score
timeFrame: through study completion, an average of 13 months
measure: Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores
timeFrame: through study completion, an average of 13 months
measure: Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit.
timeFrame: through study completion, an average of 13 months
measure: 611 Concentration in Serum
timeFrame: through study completion, an average of 13 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Site 01
state: Beijing
Study officials:
References: