A Study to Evaluate Efficacy and Safety of IBI356 in Participants 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 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.

Study Overview

• Status: Recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: IBI356; Drug: Dupilumab; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 403
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: wensheng zang; Phone Number: 0512-69566088; Email: wensheng.zang@innoventbio.com
• Study Contact Backup: Name: shanl li; Phone Number: 0512-69566088; Email: shanl.li@innoventbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Jianzhong Zhang, M.D; Phone Number: 010-88325471; Email: rmzjz@126.cm
      • Contact: Yuling Shi, M.D; Phone Number: 021-36803248; Email: shiyuling1973@126.com
      • Principal Investigator: Jianzhong Zhang, M.D
      • Principal Investigator: Yuling Shi, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBI356 dose 4; Participants receive IBI356 through W16	Drug: IBI356; IBI356 by subcutaneous injection
Experimental: IBI356 dose 2; Participants receive IBI356 through W16	Drug: IBI356; IBI356 by subcutaneous injection
Experimental: Dupilumab; Participants receive dupilumab through W16	Drug: Dupilumab; Dupilumab by subcutaneous injection
Experimental: IBI356 dose 5; Participants receive IBI356 through W16	Drug: IBI356; IBI356 by subcutaneous injection
Experimental: IBI356 dose 1; Participants receive IBI356 through W16	Drug: IBI356; IBI356 by subcutaneous injection
Placebo Comparator: Placebo; Participants receive placebo through W16	Drug: Placebo; Placebo by subcutaneous injection
Experimental: IBI356 dose 3; Participants receive IBI356 through W16	Drug: IBI356; IBI356 by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	week 16, 24
Proportion of participants with EASI-75/90/100	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.	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)	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.	week 16, 24
Change in EASI from baseline	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.	Baseline to Week 48
Change in DLQI from baseline	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.	Baseline to Week 48
Change in POEM from baseline	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.	Baseline to Week 48
Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs)		Baseline to Week 48
Serum IBI356 concentrations at prespecified timepoints		Baseline to Week 24
Percentage of Participants with Treatment-emergent ADA of IBI356		Baseline to Week 24
Serum IL-13 (PD marker) be assessed as dose-dependent drug responses		Baseline to Week 48

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 15, 2025
• First Submitted That Met QC Criteria: December 29, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; dupilumab
• Other Study ID Numbers: CIBI356A201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No