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Monoclonal Antibodies

Evaluate Efficacy, PK, and Safety of FB825 in Adults With Atopic Dermatitis

Phase 2
Waitlist Available
Led By NienYi Chen, PhD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, 3, 15, 29, 57, 85, 113, 141 and 169 days

Summary

This trial is testing FB825, a medicine given through a drip, in adults with atopic dermatitis. FB825 works by blocking certain substances in the body that cause allergic reactions. The study aims to see if FB825 is safe and effective for these patients.

Eligible Conditions
  • Atopic Dermatitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, 3, 15, 29, 57, 85, 113, 141 and 169 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, 3, 15, 29, 57, 85, 113, 141 and 169 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The mean change of Eczema Area and Severity Index [EASI] from baseline to Week 16
Secondary study objectives
Measure the profile of FB825 concentration in blood serum after administrating FB825.
Proportion of patients with Eczema Area and Severity Index [EASI-90] ( ≥90 % improvement from baseline) at Weeks 2, 4, 8, 12, 16, 20 and 24
Proportion of patients with Eczema Area and Severity Index≥50% [ EASI-50] ( ≥50% improvement from baseline) at Weeks 2, 4, 8, 12, 16, 20 and 24
+9 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: FB825Active Control1 Intervention
FB825
Group II: PlaceboPlacebo Group1 Intervention
Formulation buffer

Find a Location

Who is running the clinical trial?

Oneness Biotech Co., Ltd.Lead Sponsor
20 Previous Clinical Trials
1,348 Total Patients Enrolled
NienYi Chen, PhDPrincipal InvestigatorOneness Biotech
2 Previous Clinical Trials
140 Total Patients Enrolled
~17 spots leftby Dec 2025
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