Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of 611 when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 611 | Drug | subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score) | Baseline to Week 16 | |
| Percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16 | Baseline to Week 16 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Dermatology Hospital | Shanghai | Shanghai Municipality | 200050 | China | ||
| Hangzhou First People's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | subcutaneous injection |
|
| Topical corticosteroid | Drug | Topical |
|
| Hangzhou |
| Zhejiang |
| 31003 |
| China |
| The First Affiliated Hospital of Ningbo University | Ningbo | Zhejiang | 315010 | China |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C071192 | entacapone |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided