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Monoclonal Antibodies

FB825 for Eczema

Phase 2
Recruiting
Led By Chia-Yu Chu
Research Sponsored by Oneness Biotech Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

"This trial will test the effectiveness and safety of a new medication called FB825 in adults with moderate-to-severe atopic dermatitis. Participants will receive either the medication or a placebo, and neither the

Who is the study for?
Adults aged 18-65 with moderate-to-severe atopic dermatitis, who haven't responded well to topical treatments, can join this trial. They should have a history of the condition for at least 12 months and meet specific severity scores (EASI ≥16 and vIGA-AD ≥3). Participants must also have a significant area affected by eczema (>10% BSA) and experience intense itching.
What is being tested?
The study is testing FB825, a new medication given as repeat subcutaneous injections, against a placebo. The goal is to see if FB825 is effective in reducing symptoms of atopic dermatitis. This process involves randomly assigning participants to either the treatment or placebo group without them knowing which one they're receiving.
What are the potential side effects?
Potential side effects are not specified here but generally could include reactions at the injection site, allergic responses, or other systemic effects since it's an investigational drug being tested for safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I weigh at least 40 Kg.
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I have been diagnosed with severe skin eczema for over a year.
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Over 10% of my skin is affected by my condition.
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My average itchiness score is 3 or more on a scale of 0-10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: FB825Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FB825
2015
Completed Phase 2
~80

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Who is running the clinical trial?

Oneness Biotech Co., Ltd.Lead Sponsor
20 Previous Clinical Trials
1,357 Total Patients Enrolled
Chia-Yu ChuPrincipal InvestigatorNational Taiwan University Hospital
~60 spots leftby Dec 2025
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