A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis

Oneness Biotech Co., Ltd.

Summary

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.

Description

This multicenter, randomized, double-blind, placebo-controlled, 2-arm, parallel-group study will enroll approximately 90 subjects with moderate-to-severe atopic dermatitis, with approximately 45 subjects per group. The study duration of subject participation in the study is up to 28 weeks, including up to 4 weeks for screening, a 12-week study intervention and a 12-week follow-up period after study intervention. The study treatment will be administered as 5 SC doses.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: 1. The subject is male or female between 18 and 65 years of age at the time of giving informed consent. 2. Body weight equal to or greater than 40 Kg at the time of screening. 3. 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. 4. Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline visits. 5. Validated Investigator Global Assessment for Atopic Dermatitis (…

Interventions

Drug
FB825
The study treatment will be administered as 5 SC doses in total 12 weeks
Drug
Placebo
The study treatment will be administered as 5 SC doses in total 12 weeks

Locations (16)

First OC Dermatology
Fountain Valley, California
Center for Dermatology Clinical Research, Inc.
Fremont, California
California Allergy and Asthma Medical Group
Los Angeles, California
University of California, Davis Health, Department of Dermatology
Sacramento, California
UT Health Science Houston
Bellaire, Texas
Center for Clinical Studies
Webster, Texas