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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
403
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercent 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.
Time frame: week 24
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).
Time frame: week 16, 24
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 48
Change in DLQI from baseline
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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.
Time frame: 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.
Time frame: Baseline to Week 48
Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs)
Time frame: Baseline to Week 48
Serum IBI356 concentrations at prespecified timepoints
Time frame: Baseline to Week 24
Percentage of Participants with Treatment-emergent ADA of IBI356
Time frame: Baseline to Week 24
Serum IL-13 (PD marker) be assessed as dose-dependent drug responses
Time frame: Baseline to Week 48