Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:24 AM
Study NCT ID:
NCT07399067
Status:
RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
Sponsor:
Innovent Biologics (Suzhou) Co. Ltd.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: