The primary objective of this Phase 2 study is to evaluate the efficacy and safety of IBI3002 in patients with moderate to severe Atopic Dermatitis (AD).
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamic (PD) effects of IBI3002 in Chinese participants with moderate-to-severe AD. A total of approximately 120 participants with moderate-to-severe AD are planned for enrollment. Intensive blood collection, categorized as yes or no, and baseline disease severity, categorized as moderate (vIGA-AD = 3) or severe (vIGA-AD = 4), will be used as a stratification factor. Eligible participants will be randomized to six treatment groups in a 2:1:1:2:2:2 ratio, including multiple dose levels of IBI3002, dupilumab, and matched placebo administered subcutaneously at specified intervals. The study will assess changes in clinical efficacy measures, PK parameters, immunogenicity, and PD biomarkers over the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
China-japan Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGPercentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16
Percentage change from baseline in the EASI score at Week 16 in participants with moderate to severe AD after administration of IBI3002. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Time frame: Week 16
Number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Percentage of participants who have experienced AEs/SAEs.
Time frame: Up to 20 weeks
Pharmacokinetic parameter Cmax of IBI3002 following multiple doses
Maximum observed concentration (Cmax) of IBI3002 following multiple doses.
Time frame: Up to 20 weeks
Pharmacokinetic parameter Tmax of IBI3002 following multiple doses
Time to reach maximum concentration (Tmax) of IBI3002 following multiple doses.
Time frame: Up to 20 weeks
Pharmacokinetic parameter AUC of IBI3002 following multiple doses
Area under the concentration-time curve (AUC) of IBI3002 following multiple doses.
Time frame: Up to 20 weeks
Immunogenicity of IBI3002 following multiple doses
Immunogenicity will be assessed by the incidence of anti-drug antibodies (ADAs) in participants receiving IBI3002.
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Time frame: Up to 20 weeks
Percentage of participants with a validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost Clear) and a reduction ≥ 2 points from baseline at Week 16
The vIGA-AD is a 5-point scale used to assess the overall severity of AD based on key acute clinical signs, including erythema, induration/papulation, oozing/crusting (lichenification excluded). The rating of clear (0), almost clear (1), mild (2), moderate (3) and severe (4), will be assessed at scheduled visits. The vIGA-AD must be conducted before the EASI assessment. The vIGA-AD is a static assessment performed independently of previous scores and is conducted prior to the EASI assessment.
Time frame: Week 16
Proportion of participants with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 16
Proportion of patients with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 16. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Time frame: Week 16
Proportion of participants with a ≥ 75% improvement from baseline in EASI (EASI-75) at Week 16
Proportion of patients with a ≥ 75% improvement from baseline in EASI (EASI-75) at Week 16. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Time frame: Week 16
Proportion of participants with a ≥ 90% improvement from baseline in EASI (EASI-90) at Week 16
Proportion of patients with a ≥ 90% improvement from baseline in EASI (EASI-90) at Week 16. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Time frame: Week 16
Proportion of participants with a 100% Improvement from baseline in EASI (EASI-100) at Week 16
Proportion of patients with a 100% improvement from baseline in EASI (EASI-100) at Week 16. EASI is used to assess the severity and extent of AD by evaluating four disease signs: (1) erythema, (2) induration/papulation, (3) excoriation, and (4) lichenification. The total EASI score ranges from 0 to 72, with higher scores indicating more severe disease. EASI-50: ≥ 50% reduction in score from baseline; EASI-75: ≥ 75% reduction in score from baseline; EASI-90: ≥ 90% reduction in score from baseline. EASI-100: 100% reduction in score from baseline.
Time frame: Week 16
Proportion of participants achieving vIGA-AD 0 or 1 at Week 16
The vIGA-AD is a 5-point scale assessing overall disease severity based on key acute clinical signs. Scores range from 0 (clear) to 4 (severe). The proportion of participants with a score of 0 (clear) or 1 (almost clear) will be assessed at Week 16.
Time frame: Week 16
Proportion of participants with ≥2-point reduction from baseline in vIGA-AD score at Week 16
The vIGA-AD is a 5-point scale assessing overall disease severity based on key acute clinical signs. Scores range from 0 (clear) to 4 (severe). The proportion of participants achieving a ≥2-point reduction from baseline will be assessed at Week 16.
Time frame: Week 16
Proportion of participants with ≥4-point reduction from baseline in weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) during at Week 16
The PP-NRS is a patient-reported tool used to assess the intensity of pruritus (itch) over a 24-hour recall period. Participants rate their worst itch on an 11-point scale from 0 (no itch) to 10 (worst itch imaginable) by answering: "On a scale of 0 to 10, how would you rate your worst itch during the previous 24 hours?" Higher scores indicate greater itch severity. At least 4 daily scores out of 7 days are required to calculate the weekly average score.
Time frame: Week 16