NCT06397911 · Oneness Biotech Co., Ltd.
Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis
What this study is about
This is a randomly assigned, compared against an inactive treatment and where neither patients nor doctors know which treatment is given study to evaluate the effectiveness, how the drug moves through the body, and Safety of repeat injected under the skin doses of FB825 in adults with moderate-to-severe atopic dermatitis.
View original scientific description
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.
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
Primary outcome measures
The percentage change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: Week 16
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 (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. 8. History
Where
- Fountain Valley, California
- Fremont, California
- Los Angeles, California
- Sacramento, California
- Bellaire, Texas
- Webster, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 15, 2026 · Source of record for eligibility and locations