NCT07399067

A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Proof-of-Concept Study to Evaluate the Efficacy and Safety of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	IBI3002	IBI3002 will be administered subcutaneously at the assigned dose level and dosing interval.
DRUG	Placebo	Matched placebo will be administered subcutaneously at the same schedule as IBI3002.
DRUG	Dupilumab	Dupilumab 300mg Q2w, with a loading dose of 600mg, will be administered subcutaneously.

Timeline

• Start date: 2026-02-06
• Primary completion: 2027-03-23
• Completion: 2027-05-27
• First posted: 2026-02-10
• Last updated: 2026-02-13

Locations

1 site across 1 country: China