Actively Recruiting
A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-02-13
120
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Proof-of-Concept Study of IBI3002 in Patients With Moderate to Severe Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent and agree to follow study requirements
- Age between 18 and 75 years old
- Body weight 40 kg or more and BMI between 18 and 35 kg/m²
- Participants of childbearing potential and their partners must agree to use specified contraception during and for 6 months after the study
- Diagnosed with moderate to severe Atopic Dermatitis for at least 12 months meeting 2014 American Academy of Dermatology criteria
- At screening and randomization, EASI score 16 or higher, vIGA-AD score 3 or higher, body surface area involved 10% or more, and baseline Peak Pruritus Numerical Rating Scale (PP-NRS) 4 or higher
- History of inadequate response to topical therapy in the past 12 months or medical reasons making topical therapy unsuitable
You will not qualify if you...
- Clinically significant diseases affecting safety or participation, including psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, hematologic, or metabolic disorders
- Known or suspected active or latent tuberculosis
- History of malignant tumors except for surgically removed or cured localized basal or squamous cell carcinomas
- History of severe systemic allergic reactions such as anaphylaxis or laryngeal edema
- Fainting at the sight of needles or inability to tolerate intravenous puncture
- Pregnant or breastfeeding women, or positive pregnancy test at screening or randomization
- Receipt of investigational drugs within 3 months or 5 half-lives before randomization or current participation in another trial
- Serious infection requiring hospitalization or intravenous therapy within 3 months, recent surgery within 3 months, infection requiring oral medication within 1 month, or planned surgery during the study
- Receipt of live vaccines (except influenza vaccine) within 1 month before randomization or planned vaccination during the study
- History of parasitic infections within 6 months before screening or plans to travel to parasite-endemic regions within 6 months after study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
China-japan Friendship Hospital
Beijing, Beijing Municipality, China, 100192
Actively Recruiting
Research Team
M
Man Yang
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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