This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy, pharmacokinetics, and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis.
The subject is male or female between 18 and 65 years of age at the time of giving informed consent.
Body weight equal to or greater than 40 Kg at the time of screening.
The subject has a physician-confirmed diagnosis of moderate-to-severe atopic dermatitis based on 12 months history of symptoms designated by Hanifin and Rajka criteria.
Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visits.
Female subjects who are pregnant or lactating
The subject with positive test results for HBeAg or HCV RNA should be excluded as they are indications of active hepatitis B virus and hepatitis C virus replication.
A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag/Ab combo test) at screening or a history of HIV infection.
The subject has a history of alcohol or drug abuse within one year prior to screening that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
Parallel
FB825
DrugThe study treatment will be administered as 5 SC doses in total 12 weeks
Placebo
DrugThe study treatment will be administered as 5 SC doses in total 12 weeks
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
The mean change from baseline in Eczema Area and Severity Index (EASI) score
Proportion of patients with EASI-75 (≥75% improvement from baseline)
Proportion of patients with EASI-50 (≥50% improvement from baseline)
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