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 multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI356 dose 4 | Experimental | Participants receive IBI356 through W16 |
|
| IBI356 dose 2 | Experimental | Participants receive IBI356 through W16 |
|
| Dupilumab | Experimental | Participants receive dupilumab through W16 |
|
| IBI356 dose 5 | Experimental | Participants receive IBI356 through W16 |
|
| IBI356 dose 1 | Experimental | Participants receive IBI356 through W16 |
|
| Placebo | Placebo Comparator | Participants receive placebo through W16 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab | Drug | Dupilumab by subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in Eczema Area and Severity Index (EASI) score | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) with a ≥2-point reduction | The vIGA-AD is sn investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). | week 16, 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wensheng zang | Contact | 0512-69566088 | wensheng.zang@innoventbio.com | |
| shanl li | Contact | 0512-69566088 | shanl.li@innoventbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
Not provided
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C582203 | dupilumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| IBI356 dose 3 |
| Experimental |
Participants receive IBI356 through W16 |
|
| Drug |
Placebo by subcutaneous injection |
|
| IBI356 | Drug | IBI356 by subcutaneous injection |
|
| Proportion of participants with EASI-75/90/100 | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. | week16, 24 |
| Proportion of participants with a ≥4-point reduction from baseline in the weekly average of the Peak Pruritus-Numerical Rating Scale (PP-NRS) | The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable. | week 16, 24 |
| Change in EASI from baseline | The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. | Baseline to Week 48 |
| Change in DLQI from baseline | The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL. | Baseline to Week 48 |
| Change in POEM from baseline | The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life. | Baseline to Week 48 |
| Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) | Baseline to Week 48 |
| Serum IBI356 concentrations at prespecified timepoints | Baseline to Week 24 |
| Percentage of Participants with Treatment-emergent ADA of IBI356 | Baseline to Week 24 |
| Serum IL-13 (PD marker) be assessed as dose-dependent drug responses | Baseline to Week 48 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |