Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
611 · 5 trials · 6 indications
Moderate exacerbations were recorded by the Investigator and defined as acute exacerbation of COPD (AECOPD) event that required systemic corticosteroids with/without antibiotics. Severe exacerbations were also recorded by the Investigator and defined as AECOPD event that required hospitalization or observation for \>24 hours in an emergency department/urgent care facility or resulted in death.
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
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.
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.
Incidence of treatment-emergent adverse events (TEAEs) will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments.
| Arm | Type | Description |
|---|---|---|
| 611 | EXPERIMENTAL | 611 Q2W, subcutaneous (SC) injection |
| placebo | PLACEBO_COMPARATOR | placebo Q2W, subcutaneous (SC) injection |
| 611 interval 1+Topical Corticosteroid | EXPERIMENTAL | Participants will receive 611 according to established dosing interval 1. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. |
| 611 interval 2+Topical Corticosteroid | EXPERIMENTAL | Participants will receive 611 according to established dosing interval 2. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. |
| Placebo+Topical Corticosteroid | PLACEBO_COMPARATOR | Participants will receive Placebo according to according to established dosing intervals. TCS will be initiated at Baseline in all patients and may be tapered or stopped, as needed, based on treatment response. |
| 611 dose 1 plus placebo | EXPERIMENTAL | One subcutaneous injections of 611 150 mg on Day 1, followed by a 4-week observation period. Two subcutaneous injections of 611 150 mg (for a total of 300 mg) as a loading dose on Week 0 Day 29, followed by one 150 mg injection quaque week (QW) from Week 1 to Week 15 (15 cycles). |
| 611 dose 2 plus placebo | EXPERIMENTAL | Two subcutaneous injections of 611 150 mg (for a total of 300 mg) on Day 1, followed by a 4-week observation period. Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 29, followed by one 300 mg injection quaque 2 week (Q2W) from Week 1 to Week 15 (8 cycles). |
| 611 dose 3 plus placebo | EXPERIMENTAL | Four subcutaneous injections of 611 150 mg (for a total of 600 mg) on Day 1, followed by a 4-week observation period. Four subcutaneous injections of 611 150 mg (for a total of 600 mg) as a loading dose on Week 0 Day 29, followed by one 300 mg injection QW from Week 1 to Week 15 (15 cycles). |
| Cohort 1 | EXPERIMENTAL | 611 dose 1 (45mg) plus placebo |
| Cohort 2 | EXPERIMENTAL | 611 dose 2 (150mg) plus placebo |
| Cohort 3 | EXPERIMENTAL | 611 dose 3 (300mg) plus placebo |
| Cohort 4 | EXPERIMENTAL | 611 dose 4 (450mg) plus placebo |
| Cohort 5 | EXPERIMENTAL | 611 dose 5 (600mg) plus placebo |
| Name | Type | Description |
|---|---|---|
| 611 | DRUG | 611 subcutaneous (SC) injection |
| Placebo | DRUG | placebo Q2W, subcutaneous (SC) injection |
| Topical corticosteroid | DRUG | Topical |
| 611 150mg | DRUG | subcutaneous injection, 150 mg (single dose treatment period) + 300mg (loading dose, week 0) + 150mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles) |
| 611 300mg | DRUG | subcutaneous injection, 300 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg Q2W (maintenance dose, from Week 1 to Week 15, 8 cycles) |
| 611 600mg | DRUG | subcutaneous injection, 600 mg (single dose treatment period) + 600mg (loading dose, week 0) + 300mg QW (maintenance dose, from Week 1 to Week 15, 15 cycles) |
Inclusion Criteria: 1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study. 2. Male or female adults ages 40 to 85 years old when signing the informed consent. 3. Current or former smokers with a smoking history ...