Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
611 · 8 trials · 6 indications
concentration of 611(Recombinant Humanized Anti-interleukin-4 Receptor Alpha IgG4 Monoclonal Antibody) .
The EASI score is used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score range from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity
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 |
|---|---|---|
| Part A (Open-label PK study) | EXPERIMENTAL | Age cohort :≥2 years old to \<6 years old |
| Part B (Double-blind confirmatory study) 611 | EXPERIMENTAL | The results of part A will be used to guide the enrollment for participants aged ≥2 years to \<6 years with AD for part B. |
| Part B (Double-blind confirmatory study) placebo | PLACEBO_COMPARATOR | - |
| 611 | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| 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 | Solution for injection, subcutaneous (SC) |
| Matching placebo | DRUG | Solution for injection, subcutaneous (SC) |
| 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. The participants and their legally acceptable representatives are able to understand and comply with the research procedures, agree to participate in the research, and sign the Informed Consent Form (ICF) ; 2. When signing the informed consent form, the age should be ≥ 2 year...
611 is an investigational small molecule being developed for atopic dermatitis, chronic obstructive pulmonary disease (COPD), and sinusitis. It is currently in Phase 3 clinical trials for moderate-to-severe atopic dermatitis and moderate-to-severe COPD. The drug is also being studied in healthy volunteers for safety and pharmacokinetics.
611 is being developed by Sunshine Biopharma Inc., a company traded on the NASDAQ under the ticker symbol SBFM. The company is conducting clinical trials for 611 in the United States and China, focusing on dermatology and respiratory conditions.
611 is in Phase 3 clinical development. It has completed Phase 1 trials in healthy volunteers and in Chinese patients with atopic dermatitis. Currently, two Phase 3 trials are ongoing: one in atopic dermatitis and one in chronic obstructive pulmonary disease (COPD).
611 has four clinical trials. Completed trials include NCT04527718, a Phase 1 study in healthy volunteers in the US, and NCT05641558, a Phase 1 study in Chinese patients with atopic dermatitis. Active trials include NCT06554847, a Phase 3 study in atopic dermatitis, and NCT07039669, a Phase 3 study in COPD.
611 is not FDA approved. It is an investigational drug currently in clinical development. The drug has completed Phase 1 trials and is now in Phase 3 trials for atopic dermatitis and chronic obstructive pulmonary disease (COPD). Approval status has not been established.