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This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 611 Dose A | Experimental | 611 300 mg Q2W, subcutaneous (SC) injection. |
|
| 611 Dose B | Experimental | 611 450 mg Q4W, subcutaneous (SC) injection. |
|
| Placebo | Placebo Comparator | Placebo subcutaneous (SC) injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 611 | Drug | 611 subcutaneous (SC) injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 16 in Bilateral Nasal Polyp Score (NPS) | NPS is evaluated by nasal endoscopy. For each nostril, NPS is graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Bilateral NPS is the sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease. | Up to 16 weeks |
| Change From Baseline at Week 16 in Nasal Congestion Symptom Severity Score (NCS) | NCS is assessed by the participants daily from visit 1 and throughout the study on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicates more severity. | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the End of study in Lund Mackay Score | The Lund Mackay Score scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses using following grading: 0 = normal, 1 = partial opacification, 2 = total opacification. The total score is the sum of scores from each side and ranges from 0 (normal) to 24 (more opacified); higher score indicated more severe disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qinghong Zhou, BS | Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Study Director |
| Luo Zhang, MD | Beijing Tongren Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 03 | Beijing | Beijing Municipality | 100005 | China | ||
| Site 01 |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D009298 | Nasal Polyps |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
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| ID | Term |
|---|---|
| C071192 | entacapone |
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| Placebo |
| Drug |
Placebo subcutaneous (SC) injection. |
|
| Up to 16 weeks |
| Change From Baseline to the End of study in Total Nasal Symptom Score (TNSS) | TNSS is a composite of nasal congestion, loss of smell, and rhinorrhea (anterior/posterior nasal discharge), each access on 0-3 categorical scale (where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms). Total score ranges from 0 (no symptoms) to 12 (severe symptoms). Higher score indicated more severe symptoms. | Up to 16 weeks |
| Change From Baseline to the End of study in the University of Pennsylvania Smell Identification Test (UPSIT) Score | The UPSIT is a 40-item test to measure the individual's ability to detect odors. Total score ranges from 0 (anosmia) to 40 (normal sense of smell), lower score indicated severe smell loss. | Up to 16 weeks |
| Change From Baseline to the End of study in 22-item Sino-nasal Outcome Test (SNOT-22) Scores | The SNOT-22 is a validated questionnaire that used to assess the impact of chronic rhinosinusitis phenotype with nasal polyps (CRSwNP) on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. | Up to 16 weeks |
| 611 Concentration in Serum | The concentration of 611 in Serum. | Up to 24 weeks |
| Beijing |
| Beijing Municipality |
| 100730 |
| China |
| Site 04 | Wuhan | Hubei | 430022 | China |
| Site 02 | Xuzhou | Jiangsu | 221004 | China |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |