IBI3002 treatment for moderate to severe atopic dermatitis

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

This Phase 2 study will test whether the injectable drug IBI3002 helps adults with moderate to severe atopic dermatitis compared with dupilumab and placebo.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Drugs / interventions: dupilumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07399067 on ClinicalTrials.gov

What this trial studies

This Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolls about 120 Chinese adults with moderate-to-severe atopic dermatitis to test multiple dose levels of IBI3002 versus dupilumab and matched placebo. Participants are stratified by baseline disease severity and whether they undergo intensive blood collection, and randomized into six groups in a 2:1:1:2:2:2 ratio receiving subcutaneous injections at specified intervals. The trial will measure clinical efficacy (including EASI, vIGA-AD, and PP-NRS), safety and tolerability, pharmacokinetics, immunogenicity, and pharmacodynamic biomarkers over the treatment period. Results will inform whether IBI3002 has a favorable benefit–risk profile to justify further development.

Who should consider this trial

Good fit: Adults 18–75 years old with a physician-confirmed diagnosis of atopic dermatitis for at least 12 months who have moderate-to-severe disease at screening (EASI ≥16, vIGA-AD ≥3, BSA ≥10%, PP-NRS ≥4), weigh ≥40 kg, have BMI 18–35 kg/m², and a history of inadequate response to topical therapy are the intended candidates.

Not a fit: People with mild atopic dermatitis, those outside the specified age, weight or BMI ranges, pregnant or breastfeeding individuals, or those with protocol-specified medical exclusions are unlikely to be eligible or to benefit from this study.

Why it matters

Potential benefit: If effective, IBI3002 could provide another injectable option to reduce skin inflammation and itching for adults with moderate-to-severe atopic dermatitis.

How similar studies have performed: Approved biologics such as dupilumab have shown clear benefit in moderate-to-severe AD, but IBI3002 is a novel agent and this proof-of-concept Phase 2 trial is testing whether it can provide similar or improved effects.

Eligibility criteria

Inclusion Criteria:

1. Ability to understand and sign written informed consent prior to any study procedures and willingness to comply with study requirements throughout the study.
2. Age between 18 and 75 years old (inclusive).
3. Body weight ≥40 kg, with a Body Mass Index (BMI) between 18 and 35 kg/m² (inclusive).
4. Participants of childbearing potential and their partners must agree to strictly follow contraceptive measures specified in the protocol during the study and for 6 months after study completion.
5. At the time of screening, meet the diagnostic criteria for atopic dermatitis according to the 2014 American Academy of Dermatology consensus, and have been diagnosed with AD for at least 12 months.
6. At screening and randomization, participants must have an EASI score ≥16, vIGA-AD score ≥3, involved body surface area (BSA) ≥10%, and baseline PP-NRS ≥4.
7. History of inadequate response to topical therapy within the past 12 months, or documented medical reasons making topical therapy unsuitable (e.g., severe adverse reactions or safety concerns).

Exclusion Criteria:

1. Clinically significant diseases that may affect safety or study participation, including but not limited to psychiatric, CNS, cardiovascular, digestive, respiratory, urinary, hematologic, or metabolic disorders.
2. Known history of active tuberculosis or clinically suspected tuberculosis (including but not limited to pulmonary tuberculosis, lymph node tuberculosis, tuberculous pleurisy, etc.); or chest imaging suggestive of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
3. History of malignant tumors, except for surgically removed or cured localized basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin.
4. History of severe systemic allergic reactions (e.g., anaphylaxis, laryngeal edema).
5. Fainting at the sight of needles, blood, or inability to tolerate intravenous puncture.
6. Pregnant or breastfeeding women, or female participants who test positive for pregnancy during screening or at randomization.
7. Receipt of other investigational drugs within 3 months or 5 half-lives before randomization (whichever is longer), or current participation in another clinical trial.
8. Had a serious infection (defined as requiring hospitalization or intravenous anti-infective therapy) or trauma within the 3 months prior to randomization, or a history of surgery within 3 months, or an infection requiring oral medication within 1 month, or plans to undergo surgery during the study period.
9. Receipt of any live vaccines (except influenza vaccine) within 1 month before randomization, or planning to receive vaccination during the study.
10. History of parasitic infections within 6 months before screening, or planning to travel to parasite-endemic countries/regions in Africa, South America, and southern parts of Asia (including Southeast Asia, India, Nepal) within 6 months after study completion.

Where this trial is running

Beijing, Beijing Municipality

• China-japan Friendship Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Man Yang

Conditions Atopic Dermatitis