Actively Recruiting
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
Led by Innovent Biologics (Suzhou) Co. Ltd. · Updated on 2026-02-13
120
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of IBI3002 in adults with moderate to severe Atopic Dermatitis (AD). This Phase 2, multicenter, randomized, double-blind, placebo-controlled study includes about 120 participants who meet specific diagnostic criteria and disease severity measures. The study aims to assess how IBI3002 compares to placebo and dupilumab in improving skin condition and symptom measures related to AD. Participants will be randomly assigned to one of six groups receiving different doses of IBI3002, dupilumab, or matched placebo. All treatments are given by subcutaneous injection at specified intervals. The study includes multiple dose levels of IBI3002 and a loading dose of dupilumab followed by regular dosing. Treatment effects will be assessed over a 16-week period, with additional evaluations up to 20 weeks. During the study, participants will undergo blood collection, clinical assessments including the Eczema Area and Severity Index (EASI), Investigator's Global Assessment for AD, and symptom rating scales. Safety and tolerability will be monitored through reports of adverse events and pharmacokinetic testing. The primary outcome is the percentage change in EASI score at Week 16, with other measures including immunogenicity and pharmacodynamic effects. Participation involves regular visits and assessments through the treatment and follow-up periods.
CONDITIONS
Brief 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...
- Able to understand and sign informed consent and willing to follow study requirements
- Age between 18 and 75 years old
- Body weight at least 40 kg and BMI between 18 and 35 kg/m²
- Agree to use strict contraceptive measures during the study and for 6 months after if of childbearing potential
- Diagnosed with Atopic Dermatitis according to 2014 American Academy of Dermatology criteria for at least 12 months
- At screening and randomization have EASI score 16 or higher, vIGA-AD score 3 or higher, affected body surface area 10% or more, and baseline Peak Pruritus Numerical Rating Scale 4 or higher
- History of inadequate response to topical therapy in past 12 months or medical reason topical therapy is unsuitable
You will not qualify if you...
- Significant diseases affecting safety or study participation, including psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, blood, or metabolic disorders
- Known or suspected active or latent tuberculosis or chest imaging suggesting tuberculosis
- History of malignant tumors except surgically removed or cured localized basal or squamous cell skin carcinoma
- History of severe systemic allergic reactions such as anaphylaxis or laryngeal edema
- Fainting at sight of needles, blood, or unable to tolerate intravenous puncture
- Pregnant, breastfeeding, or tested positive for pregnancy during screening or randomization
- Use of other investigational drugs within 3 months or 5 half-lives, or current participation in another trial
- Serious infection requiring hospitalization or intravenous therapy within 3 months, recent surgery or infection requiring oral medication, or planned surgery during study
- Receipt of live vaccines (except influenza) within 1 month before randomization or planned vaccination during study
- History of parasitic infections within 6 months or planned 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive subcutaneous injections of IBI3002, dupilumab, or placebo at assigned dose levels and schedules to evaluate efficacy and safety in moderate to severe atopic dermatitis.
Multiple visits according to the dosing schedule up to Week 16
Duration - Up to 4 weeks after treatment
Participants are monitored for safety and adverse events after treatment completion.
Visits up to Week 20 for safety assessments
Trial Site Locations
Total: 1 location
1
China-japan Friendship Hospital
Beijing, Beijing Municipality, China, 100192
Actively Recruiting
Research Team
M
Man Yang
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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