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).
Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study.
Age between 18 and 75 years old (inclusive).
Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive).
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.
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.
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.
History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema).
Parallel
IBI3002
DrugIBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.
Placebo
DrugMatched placebo will be administered subcutaneously at the same schedule as IBI3002.
Dupilumab
DrugDupilumab 300mg Q2w, with a loading dose of 600mg, will be administered subcutaneously.
6
Treatment groupsSee each treatment group below.
Percentage 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.
Number of participants with Adverse Events (AEs)/Serious Adverse Events (SAEs)
Percentage of participants who have experienced AEs/SAEs.
Pharmacokinetic parameter Cmax of IBI3002 following multiple doses
Maximum observed concentration (Cmax) of IBI3002 following multiple doses.
Pharmacokinetic parameter Tmax of IBI3002 following multiple doses
Time to reach maximum concentration (Tmax) of IBI3002 following multiple doses.
Pharmacokinetic parameter AUC of IBI3002 following multiple doses
Area under the concentration-time curve (AUC) of IBI3002 following multiple doses.
Click on the lead sponsor to view all of their trials.
