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

Innovent Biologics

Status and phase: Not yet enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab; Drug: IBI356; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07330934

CIBI356A201

Details and patient eligibility

About

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.

Enrollment: 403 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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403 participants in 7 patient groups, including a placebo group

IBI356 dose 4

Experimental group

Description:

Participants receive IBI356 through W16

Treatment:

Drug: IBI356

IBI356 dose 2

Experimental group

Description:

Participants receive IBI356 through W16

Treatment:

Drug: IBI356

Dupilumab

Experimental group

Description:

Participants receive dupilumab through W16

Treatment:

Drug: Dupilumab

IBI356 dose 5

Experimental group

Description:

Participants receive IBI356 through W16

Treatment:

Drug: IBI356

IBI356 dose 1

Experimental group

Description:

Participants receive IBI356 through W16

Treatment:

Drug: IBI356

Placebo

Placebo Comparator group

Description:

Participants receive placebo through W16

Treatment:

Drug: Placebo

IBI356 dose 3

Experimental group

Description:

Participants receive IBI356 through W16

Treatment:

Drug: IBI356