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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 | Experimental | 611 2ml Q2W, subcutaneous (SC) injection |
|
| Placebo | Placebo Comparator | Placebo subcutaneous (SC) injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 611 | Drug | 611 subcutaneous (SC) injection. |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 24 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 | 24 weeks |
| Change From Baseline at Week 24 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. | 24 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D012852 | Sinusitis |
| D009298 | Nasal 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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| Drug |
Placebo subcutaneous (SC) injection. |
|
| through study completion, an average of 13 months |
| 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. | through study completion, an average of 13 months |
| 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 | through study completion, an average of 13 months |
| 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 | through study completion, an average of 13 months |
| Adverse events (AEs), measurement of vital signs，physical examination，electrocardiogram and laboratory tests at each visit. | The incidence and severity of treatment emergent adverse event (TEAE), including Serious Adverse Event (SAE), as well as clinical symptoms, and any abnormalities of vital signs, physical examinations，electrocardiogram，laboratory tests and, etc. | through study completion, an average of 13 months |
| 611 Concentration in Serum | The concentration of 611 in Serum | through study completion, an average of 13 months |
| D012140 |
| Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |