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

NCT07330934 | Recruiting Phase 2

• 1 other identifier: CIBI356A201
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  week 24

Secondary Outcomes (10)

• 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

  week 16, 24

• Proportion of participants with EASI-75/90/100

  week16, 24

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

  week 16, 24

• Change in EASI from baseline

  Baseline to Week 48

• Change in DLQI from baseline

  Baseline to Week 48

Study Arms (7)

IBI356 dose 4

EXPERIMENTAL

Participants receive IBI356 through W16

Drug: IBI356

IBI356 dose 2

EXPERIMENTAL

Participants receive IBI356 through W16

Drug: IBI356

Dupilumab

EXPERIMENTAL

Participants receive dupilumab through W16

Drug: Dupilumab

IBI356 dose 5

EXPERIMENTAL

Participants receive IBI356 through W16

Drug: IBI356

IBI356 dose 1

EXPERIMENTAL

Participants receive IBI356 through W16

Drug: IBI356

Placebo

PLACEBO COMPARATOR

Participants receive placebo through W16

Drug: Placebo

IBI356 dose 3

EXPERIMENTAL

Participants receive IBI356 through W16

Drug: IBI356

Interventions

Dupilumab DRUG

Dupilumab by subcutaneous injection

Dupilumab

Placebo DRUG

Placebo by subcutaneous injection

Placebo

IBI356 DRUG

IBI356 by subcutaneous injection

IBI356 dose 1; IBI356 dose 2; IBI356 dose 3; IBI356 dose 4; IBI356 dose 5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

dupilumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

wensheng zang

CONTACT

0512-69566088; wensheng.zang@innoventbio.com

shanl li

CONTACT

0512-69566088; shanl.li@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: January 9, 2026
• Study Start: December 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

CN (1)