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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

403 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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Dupilumab

Dupilumab by subcutaneous injection

Intervention Type DRUG

Placebo

Placebo by subcutaneous injection

Intervention Type DRUG

IBI356

IBI356 by subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No