IBI356 for adults with moderate to severe atopic dermatitis

A Multi-Center, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of IBI356 in Adult Participants With Moderate to Severe Atopic Dermatitis

This trial will test whether the experimental drug IBI356, compared with placebo and dupilumab, reduces symptoms and improves skin in adults with moderate to severe atopic dermatitis.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 403 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07330934 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, parallel, placebo-controlled phase 2 trial planning to enroll about 403 adults with moderate to severe atopic dermatitis. Participants will be assigned to receive IBI356, dupilumab, or placebo and followed for measures of efficacy, safety, pharmacokinetics, immunogenicity, and pharmacodynamic changes. Key eligibility includes at least one year of AD, EASI ≥16, vIGA‑AD of 3 or 4, ≥10% body surface area involvement, and average daily itch (PP‑NRS) ≥4, with prior inadequate response to or contraindication for topical therapy. The study is conducted at multiple centers including Peking University People's Hospital, using standard clinical scales to track skin clearance, itch, and adverse events.

Who should consider this trial

Good fit: Adults aged 18 or older with at least one year of moderate to severe atopic dermatitis who meet severity thresholds (EASI ≥16, vIGA‑AD 3–4, ≥10% BSA, average PP‑NRS ≥4) and who have not had adequate benefit from or cannot use topical treatments.

Not a fit: People with mild atopic dermatitis, children under 18, those with active or suspected tuberculosis, or individuals with significant uncontrolled medical or psychiatric conditions are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, IBI356 could provide another biologic option that reduces itch and improves skin clearance for adults with moderate to severe atopic dermatitis.

How similar studies have performed: Other biologic therapies for moderate to severe AD, notably dupilumab, have demonstrated strong clinical benefits, while IBI356 is a newer agent currently being tested in this setting.

Eligibility criteria

Inclusion Criteria:

1. Able to understand and sign the informed consent form (ICF);
2. Aged ≥ 18 years, male or female;
3. Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria);
4. EASI score of 16 or higher at baseline, vIGA-AD of 3 or 4 at baseline, AD involvement of 10% or more of BSA at baseline, weekly average of daily PP-NRS of ≥ 4 at baseline;
5. Participants with documented inadequate response to topical medications or for whom topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

1. Presence of diseases that may affect the safety or efficacy, including but not limited to psychistric disorders, central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, and hematological or metabolic system diseases.
2. Known history of active tuberculosis or clinically suspected tuberculosis; or chest imaging suggesting evidence of suspected tuberculosis; or any other clinical evidence of latent tuberculosis.
3. Has known or suspected helminth or other parasitic infection.
4. History of malignancy, except excised or curatively treated localized basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).
5. History of severe drug allergy or anaphylaxis.
6. Fainting, hemophobia, or inability to tolerate venipuncture.
7. Women who are pregnant or breastfeeding, or female participants who have a positive pregnancy test at screening or randomization.
8. Have received an organ or hematopoietic stem cell transplant.
9. Positive HBsAg; or positive HBcAb with positive HBV-DNA; or positive hepatitis C antibody with positive HCV-RNA; or positive treponema pallidum antibody; or positive HIV serology at screening.
10. Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: wensheng zang

Conditions Atopic Dermatitis