Atopic Dermatitis
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGIBI3002
IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.
DRUGPlacebo
Matched placebo will be administered subcutaneously at the same schedule as IBI3002.
DRUGDupilumab
Dupilumab 300mg Q2w, with a loading dose of 600mg, will be administered subcutaneously.
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study. 2. Age between 18 and 75 years old (inclusive). 3. Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive). 4. Participants of childbearing potential and their partners must agree to strictly follow contraceptive measures specified in the protocol during the study and for 6 months after study completion. 5. At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and have been diagnosed with AD for at least 12 months. 6. At screening and randomization, participants must have an EASI score ≥16, vIGA-AD score ≥3, involved body surface area (BSA) ≥10%, and baseline PP-NRS ≥4. 7. History of inadequate response to topical therapy within the past 12 months, or documented medical reasons making topical therapy unsuitable (e.g., severe adverse reactions or safety concerns).
Exclusion criteria
1. Clinically significant diseases that may affect safety or study participation, including but not limited to psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, hematologic, or metabolic disorders. 2. Known history of active tuberculosis or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or chest imaging suggestive of suspected tuberculosis; or any other clinical evidence of latent tuberculosis. 3. History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin. 4. History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema). 5. Fainting at the sight of needles, blood, or inability to tolerate intravenous puncture. 6. Pregnant or breastfeeding women, or female participants who test positive for pregnancy during screening or at randomization. 7. Receipt of other investigational drugs within 3 months or 5 half-lives before randomization (whichever is longer), or current participation in another clinical trial. 8. Had a serious infection (defined as requiring hospitalization or intravenous anti-infective therapy) or trauma within the 3 months prior to randomization, or a history of surgery within 3 months, or an infection requiring oral medication within 1 month, or plans to undergo surgery during the study period. 9. Receipt of any live vaccines (except influenza vaccine) within 1 month before randomization, or planning to receive vaccination during the study. 10. History of parasitic infections within 6 months before screening, or planning to travel to parasite-endemic countries/regions in Africa, South America, and southern parts of Asia (including Southeast Asia, India, Nepal) within 6 months after study completion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic parameter AUC of IBI3002 following multiple doses | Up to 20 weeks | Area under the concentration-time curve (AUC) of IBI3002 following multiple doses. |
| Pharmacokinetic parameter Cmax of IBI3002 following multiple doses | Up to 20 weeks | Maximum observed concentration (Cmax) of IBI3002 following multiple doses. |
| Number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs) | Up to 20 weeks | Percentage of participants who have experienced AEs/SAEs. |
| Immunogenicity of IBI3002 following multiple doses | Up to 20 weeks | Immunogenicity will be assessed by the incidence of anti-drug antibodies (ADAs) in participants receiving IBI3002. |
| 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 | 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. |
| Proportion of participants with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 16 | 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. |
| Proportion of participants with a ≥ 75% improvement from baseline in EASI (EASI-75) at Week 16 | 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. |
| Proportion of participants with a ≥ 90% improvement from baseline in EASI (EASI-90) at Week 16 | 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. |
| Proportion of participants with a 100% Improvement from baseline in EASI (EASI-100) at Week 16 | 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. |
| Proportion of participants achieving vIGA-AD 0 or 1 at Week 16 | 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. |
| Proportion of participants with ≥2-point reduction from baseline in vIGA-AD score at Week 16 | 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. |
| Pharmacokinetic parameter Tmax of IBI3002 following multiple doses | Up to 20 weeks | Time to reach maximum concentration (Tmax) of IBI3002 following multiple doses. |
| 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 | 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. |
Countries
China
Contacts
CONTACTMan Yang
Outcome results
None listed