Actively Recruiting
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-08-07
9
Participants Needed
1
Research Sites
44 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
I
Innovent Biologics (Suzhou) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of IBI3002 in participants with moderate to severe atopic dermatitis (AD). The study plans to enroll patients with moderate to severe AD who have a poor response to topical treatment or who are not suitable for topical treatments. It aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, PD characteristics, and changes in clinical characteristics of these participants receiving multiple doses of IBI3002. The entire study includes the screening period (4 weeks before dosing), the dosing period (12 weeks), and the safety follow-up period (8 weeks). The study plans to enroll 9 to 27 participants with moderate to severe AD, who will be randomly assigned in a 1:1:1 ratio to the following 3 cohorts to receive subcutaneous injection of the corresponding dose of IBI3002 or a matching volume of placebo. Investigators and participants remain blind within the same cohort. Cohort 1: 150mg SC (IBI3002: placebo=2 :1); Cohort 2: 300mg SC (IBI3002: placebo=2 :1); Cohort 3: 600mg SC( IBI3002: placebo=2 :1); The participants need to be observed at the study site for 3 hours after each dose and are allowed to leave after investigators determine no safety risk.
CONDITIONS
Official Title
A Study to Evaluate the Safety and Tolerability of Multiple Dose of IBI3002 in Patients With Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 65 years
- Weigh at least 40 kg
- Diagnosed with atopic dermatitis for 12 months or more according to Hannifin & Rajka criteria or equivalent
- Moderate to severe atopic dermatitis with Eczema Area and Severity Index (EASI) score of 16 or higher
- Investigator's Global Assessment score of 3 or higher
- At least 10% body surface area affected by atopic dermatitis at screening and randomization
You will not qualify if you...
- Any disease that could affect safety or participation, including mental disorders or diseases of major organ systems as judged by the investigator
- History or clinical suspicion of active tuberculosis or latent tuberculosis without tolerance to preventive treatment
- History of malignant tumors except for treated localized basal cell carcinoma or squamous cell carcinoma of the skin
- Low white blood cell or neutrophil counts below normal limits at screening or randomization
- Presence of other skin conditions that may interfere with atopic dermatitis assessment as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
W
Wensheng Zang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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