A Study of IBI3033 in Moderate-to-Severe Atopic Dermatitis

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT07549984
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IBI3033 — DRUG
    Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
  • Placebo — DRUG
    Participants in placebo group will receive placebo SC.

Study Details

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.

Key Dates

First listed
Apr 24, 2026
Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Feb 10, 2027
Completion
Mar 25, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants in placebo group will receive placebo SC.
  • Experimental: IBI3033 Dose 1 Interval 1
    Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.
  • Experimental: IBI3033 Dose 2 Interval 2
    Participants in IBI3033 group will receive multiple doses of IBI3033 SC at the protocol specified dose level and time points.

Primary Outcome Measure

Incidence of adverse events (AEs)/serious adverse events (SAEs) [ Time Frame: Up to 16 weeks ]

Central Contacts

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