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NCT Number: NCT07330934

A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Jianzhong Zhang, M.D

CONTACT

[email protected]

010-88325471

Jianzhong Zhang, M.D

PRINCIPAL_INVESTIGATOR

Yuling Shi, M.D

CONTACT

[email protected]

021-36803248

Yuling Shi, M.D

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and sign the informed consent form (ICF);
  • Aged ≥ 18 years, male or female;
  • Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria);
  • 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;
  • Participants with documented inadequate response to topical medications or for whom topical treatments are otherwise medically inadvisable.

Exclusion criteria

  • 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.
  • 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.
  • Has known or suspected helminth or other parasitic infection.
  • History of malignancy, except excised or curatively treated localized basal cell carcinoma (BCC) or cutaneous squamous cell carcinoma (cSCC).
  • History of severe drug allergy or anaphylaxis.
  • Fainting, hemophobia, or inability to tolerate venipuncture.
  • Women who are pregnant or breastfeeding, or female participants who have a positive pregnancy test at screening or randomization.
  • Have received an organ or hematopoietic stem cell transplant.
  • 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.
  • 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.

Treatment and study plan

Dupilumab

Drug

Dupilumab by subcutaneous injection

Placebo

Drug

Placebo by subcutaneous injection

IBI356

Drug

IBI356 by subcutaneous injection

Primary outcomes

  1. Percent change from baseline in Eczema Area and Severity Index (EASI) score

    Time frame: week 24

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

Secondary outcomes

  1. Proportion of participants achieving Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) with a ≥2-point reduction

    Time frame: week 16, 24

    The vIGA-AD is sn investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe).

  2. Proportion of participants with EASI-75/90/100

    Time frame: week16, 24

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  3. Proportion of participants with a ≥4-point reduction from baseline in the weekly average of the Peak Pruritus-Numerical Rating Scale (PP-NRS)

    Time frame: week 16, 24

    The PP-NRS is a validated single item 0-10 numeric rating scale assessing peak pruritus (itch) associated with AD with 0 = no itch and 10 = worst itch imaginable.

  4. Change in EASI from baseline

    Time frame: Baseline to Week 48

    The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.

  5. Change in DLQI from baseline

    Time frame: Baseline to Week 48

    The DLQI is a validated 10-item questionnaire to measure dermatology-specific quality of life (QoL) in adult patients. Overall scoring ranges from 0 to 30, with a higher score indicating a poorer QoL.

  6. Change in POEM from baseline

    Time frame: Baseline to Week 48

    The POEM is a 7-item self-assessment questionnaire that assesses disease symptoms on a 5-point scale; 0 (no days) to 4 (every day in the last week). The sum of the 7 items gives the total POEM score of 0 (absent disease) to 28 (very severe). Higher scores indicated more severe disease and poor quality of life.

  7. Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs)

    Time frame: Baseline to Week 48

  8. Serum IBI356 concentrations at prespecified timepoints

    Time frame: Baseline to Week 24

  9. Percentage of Participants with Treatment-emergent ADA of IBI356

    Time frame: Baseline to Week 24

  10. Serum IL-13 (PD marker) be assessed as dose-dependent drug responses

    Time frame: Baseline to Week 48

Study contacts

Contact information is provided by the study sponsor or research team.

shanl li

CONTACT

[email protected]

0512-69566088

wensheng zang

CONTACT

[email protected]

0512-69566088

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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