Actively Recruiting
A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-03-11
403
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, randomized, double-blind, parallel, placebo-controlled phase 2 clinical study. A total of 403 adult participants with moderate to severe AD are planned to be enrolled to evaluate efficacy, safety, PK characteristics, immunogenicity, and changes in PD characteristics of IBI356.
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign the informed consent form
- Aged 18 years or older, male or female
- Diagnosis of atopic dermatitis for at least 1 year as defined by the American Academy of Dermatology Consensus Criteria
- Eczema Area and Severity Index (EASI) score of 16 or higher at baseline
- Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline
- Atopic dermatitis involvement of 10% or more of body surface area at baseline
- Weekly average of daily Peak Pruritus Numerical Rating Scale (PP-NRS) score of 4 or higher at baseline
- Documented inadequate response to topical medications or topical treatments medically inadvisable
You will not qualify if you...
- Presence of diseases that may affect safety or efficacy, including psychiatric, central nervous system, cardiovascular, digestive, respiratory, urinary, hematological, or metabolic diseases
- Known history or suspicion of active or latent tuberculosis
- Known or suspected helminth or other parasitic infection
- History of malignancy except excised or curatively treated localized basal cell carcinoma or cutaneous squamous cell carcinoma
- History of severe drug allergy or anaphylaxis
- Fainting, hemophobia, or inability to tolerate venipuncture
- Women who are pregnant or breastfeeding, or have a positive pregnancy test at screening or randomization
- Prior organ or hematopoietic stem cell transplant
- Positive tests for hepatitis B surface antigen, hepatitis B core antibody with positive HBV-DNA, hepatitis C antibody with positive HCV-RNA, treponema pallidum antibody, or HIV serology at screening
- Receipt of specified therapies within defined timeframes prior to baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
W
wensheng zang
CONTACT
S
shanl li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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