Atopic Dermatitis
Conditions
Brief summary
This is a Phase 1, randomized, double-blind, placebo-controlled, multiple ascending dose study designed to evaluate the safety, tolerability, and pharmacokinetics of IBI3033 in subjects with moderate-to-severe atopic dermatitis (AD). Approximately 16 eligible adult participants will be enrolled and sequentially assigned to one of two dose cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive IBI3033 or matching placebo. The study consists of a screening period (up to 4 weeks), a 12-week treatment period, and a 4-week safety follow-up period. The primary objective is to assess safety and tolerability based on the incidence of adverse events and serious adverse events. Secondary objectives include characterization of pharmacokinetics and immunogenicity. Exploratory assessments include pharmacodynamic biomarkers and preliminary efficacy outcomes such as changes in Eczema Area and Severity Index (EASI) and Investigator's Global Assessment (vIGA-AD) scores.
Interventions
DRUGIBI3033
Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
DRUGPlacebo
Participants in placebo group will receive placebo SC.
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. 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. 5. 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. 6. 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 |
|---|---|---|
| Incidence of adverse events (AEs)/serious adverse events (SAEs) | Up to 16 weeks | Percentage of participants who have experienced AEs/SAEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameter: Cmax | Up to 16 weeks | Observed maximum plasma concentration of IBI3033 |
| PK parameter: tmax | Up to 16 weeks | Time to achieve Cmax of IBI3033 |
| PK parameter: AUC | Up to 16 weeks | Area under the plasma concentration-time curve of IBI3033 |
| Immunogenticity profiles | Up to 16 weeks | Frequency of anti-drug antibody (ADA) of IBI3033 |
| Percentage change from baseline in the Eczema Area and Severity Index (EASI) score at Week 12 | Week 12 | Percentage change from baseline in the EASI score at Week 12 in participants with moderate to severe AD after administration of IBI3033. 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. |
| 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 12 | Week 12 | 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 12 | Week 12 | Proportion of patients with a ≥ 50% improvement from baseline in EASI (EASI-50) at Week 12. 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 12 | Week 12 | Proportion of patients with a ≥ 75% improvement from baseline in EASI (EASI-50) at Week 12. 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 12 | Week 12 | Proportion of patients with a ≥ 90% improvement from baseline in EASI (EASI-50) at Week 12. 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 12 | Week 12 | Proportion of patients with a 100% improvement from baseline in EASI (EASI-50) at Week 12. 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. |
Countries
China
Contacts
CONTACTWenjing Duan
Outcome results
None listed