Recruiting NCT07330934
A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dupilumab, Placebo, IBI356.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug Dupilumab
Dupilumab by subcutaneous injection - Drug Placebo
Placebo by subcutaneous injection - Drug IBI356
IBI356 by subcutaneous injection
Primary outcome measures
- Percent change from baseline in Eczema Area and Severity Index (EASI) score [Time frame: week 24]
Secondary outcome measures (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 [Time frame: week 16, 24]
- Proportion of participants with EASI-75/90/100 [Time frame: 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) [Time frame: week 16, 24]
- Change in EASI from baseline [Time frame: Baseline to Week 48]
- Change in DLQI from baseline [Time frame: Baseline to Week 48]
- Change in POEM from baseline [Time frame: Baseline to Week 48]
- Incidences of adverse events (AEs), treatment emergent adverse events (TEAEs), and serious adverse events (SAEs) [Time frame: Baseline to Week 48]
- Serum IBI356 concentrations at prespecified timepoints [Time frame: Baseline to Week 24]
- Percentage of Participants with Treatment-emergent ADA of IBI356 [Time frame: Baseline to Week 24]
- Serum IL-13 (PD marker) be assessed as dose-dependent drug responses [Time frame: Baseline to Week 48]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07330934 · CIBI356A201