Phase 2
Completed N=12
An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
Source: ClinicalTrials.gov NCT03758716 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: % Change From Baseline in Total IgE — -45.57 percentage change
Summary
The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Change From Baseline in Total IgE |
-45.57 | — |
| PRIMARY % Change From Baseline in Allergen-specific IgE |
-1.88; -5.81; -4.83; -22.38; -25.44; -33.22 | — |
| SECONDARY Change From Baseline in Total IgE |
482.93; -137.70; -298.07; -862.73; -1956.86; -1581.65 | — |
| SECONDARY % Change From Baseline in Allergen-specific IgE |
-1.88; -5.81; -4.83; -22.38; -25.44; -33.22 | — |
| SECONDARY % Changes From Baseline in Irritability Visual Analogue Scale (VAS) |
-32.57 | — |
| SECONDARY % Changes From Baseline in Eczema Area and Severity Index (EASI) |
-72.14 | — |
| SECONDARY % Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD) |
-56.19 | — |
| SECONDARY % Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis |
-39.58 | — |
| SECONDARY % Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis |
-60.04 | — |
| SECONDARY Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects between 20 and 65 years of age, inclusive.
- The subject has a physician-confirmed diagnosis of chronic atopic dermatitis based on 3 years history of symptoms defined by the Eichenfield revised criteria of Hannifin and Rajka and supported by positive allergen-specific IgE at the screening visit.
- Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits.
- Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and baseline visits.
- ≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.
Exclusion Criteria
- Female subjects who are pregnant or lactating.
- The subject is on diet or with poor intake.
- The subject has a history of heart arrhythmias (any clinically relevant).
- The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus types 1 and 2 antibodies at screening.
- The subject has a history of alcohol or drug abuse that would impair or risk the patients' full participation in the study, in the opinion of the investigator.
Data sourced from ClinicalTrials.gov (NCT03758716). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.