A Study to Evaluate Efficacy and Safety of IBI356 in Participants With Moderate to Severe Atopic Dermatitis
Recruiting · NCT07330934 · Interventional (participants receive a specific treatment) · Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Peking University People's Hospital - Beijing, Beijing Municipality, China