RecruitingAtopic Dermatitis
Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
Eligible age
18–65 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
No
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About this study
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.
Sponsor: Oneness Biotech Co., Ltd.
You may qualify if…
- ✓ 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 (vIGA-AD) score ≥ 3 (5-point scale) at the screening and baseline visits.
- ✓ 6. ≥10 % body surface area (BSA) of AD involvement at the screening and baseline visits.
- ✓ 7. Baseline pruritus numerical rating scale (NRS) average score for maximum itch intensity of ≥ 3, based on the average of daily pruritus NRS scores for maximum itch intensity reported during the 7 days prior to randomization.
You may not qualify if…
- ✕ Subjects to whom any of the following applies will be excluded from the study:
- ✕ 1. Female subjects who are pregnant or lactating
- ✕ 2. 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.
- ✕ 3. A positive human immunodeficiency virus (HIV) test (e.g., HIV Ag/Ab combo test) at screening or a history of HIV infection.
- ✕ 4. 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.
- ✕ 5. The subject has a clinically significant, currently active or severe gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory (with the exception of uncomplicated allergic rhinitis and allergic asthma), inflammatory, immunological, endocrine, diabetes, obesity \[BMI≥35\] or infectious disease and is ineligible to participate in the study as judged by the investigator.
- ✕ 6. The subject has a clinically significant history, as determined by the investigator, of drug allergies or hypersensitivity such as, but not limited to, sulfonamides and penicillin, or a drug allergy witnessed in a previous study with experimental drugs.
- ✕ 7. The subject has any history of a previous anaphylactic reaction.
Where it's recruiting
California
Fountain Valley · Fremont · Los Angeles · Sacramento
Texas
Bellaire · Webster
Source: ClinicalTrials.gov · NCT06397911 · last updated 2026-06-15