Atopic Dermatitis
Conditions
Brief summary
The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis
Detailed description
This is an open-labeled exploratory study to evaluate safety and efficacy of FB825 in adults with atopic dermatitis (AD). The study will be conduct at one medical center in Taiwan. Approximately 12 subjects with atopic dermatitis (AD), who meet the criteria for study entry, will be enrolled to the one-arm-study.
Interventions
DRUGFB825, FB825-15D11, Anti-CemX
Pharmaceutical form: 20mg/ml solution Route of administration: IV
Sponsors
Fountain Biopharma Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects between 20 and 65 years of age, inclusive. 2. 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. 3. Eczema Area and Severity Index (EASI) score ≧14 at the screening and baseline visits. 4. Investigator's Global Assessment (IGA) score ≧ 3 (5-point scale) at the screening and baseline visits. 5. ≧10 % body surface area (BSA) of AD involvement at the screening and baseline visits.
Exclusion criteria
1. Female subjects who are pregnant or lactating. 2. The subject is on diet or with poor intake. 3. The subject has a history of heart arrhythmias (any clinically relevant). 4. 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. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Change From Baseline in Total IgE | Day 169 | Detect total IgE in serum by ImmunoCAP. |
| % Change From Baseline in Allergen-specific IgE | Day 169 | Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| % Changes From Baseline in Irritability Visual Analogue Scale (VAS) | Days 85 | VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient. |
| % Changes From Baseline in Eczema Area and Severity Index (EASI) | Day 85 | EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient. |
| % Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD) | Days 169 | SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient. |
| Change From Baseline in Total IgE | Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825) | Detect total IgE in serum by ImmunoCAP. |
| % Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis | Days 169 | BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient. |
| Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs) | through study completion, an average of 1 year. | Safety will be assessed by monitoring and recording of adverse events (AEs) and serious adverse event (SAEs); physical examination findings and vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature), clinical laboratory test results (hematology, coagulation, serum chemistry \[including liver function tests, blood glucose level\], and urinalysis); 12-lead ECG results. |
| % Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis | Days 169 | IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient. |
| % Change From Baseline in Allergen-specific IgE | Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825) | Detect specific IgE in serum by ImmunoCAP. (Dog dander) |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| FB825 Only one arm in the study. The subjects are planned to be dosed by IV injection with experimental drug FB825. The other name of FB825 is FB825-15D11, or Anti-CemX.
FB825, FB825-15D11, Anti-CemX: Pharmaceutical form: 20mg/ml solution Route of administration: IV | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | FB825 |
|---|---|
| Age, Continuous | 30.75 years STANDARD_DEVIATION 6.88 |
| EASI Scores | 25.98 units on a scale STANDARD_DEVIATION 8.34 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment Taiwan | 12 participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
| Total IgE | 6611.53 IU/mL STANDARD_DEVIATION 6693.41 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 9 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
% Change From Baseline in Allergen-specific IgE
Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)
Time frame: Day 169
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Change From Baseline in Allergen-specific IgE | -50.16 percentage change | Standard Deviation 23.61 |
Primary
% Change From Baseline in Total IgE
Detect total IgE in serum by ImmunoCAP.
Time frame: Day 169
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Change From Baseline in Total IgE | -45.57 percentage change | Standard Deviation 21.27 |
Secondary
% Change From Baseline in Allergen-specific IgE
Detect specific IgE in serum by ImmunoCAP. (Dog dander)
Time frame: Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 1 Day 8 | -1.88 percentage change | Standard Deviation 12.87 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 1 Day 15 | -5.81 percentage change | Standard Deviation 17.92 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 1 Day 29 | -4.83 percentage change | Standard Deviation 21.74 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 1 Day 57 | -22.38 percentage change | Standard Deviation 20.98 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 2 Day 85 | -25.44 percentage change | Standard Deviation 15.01 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 2 Day 92 | -33.22 percentage change | Standard Deviation 17.42 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 2 Day 99 | -36.30 percentage change | Standard Deviation 17.8 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 2 Day 113 | -35.02 percentage change | Standard Deviation 16.81 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 2 Day 141 | -44.07 percentage change | Standard Deviation 16.4 |
| FB825 | % Change From Baseline in Allergen-specific IgE | Dose 2 Day 169/ EOS | -46.94 percentage change | Standard Deviation 15.02 |
Secondary
Change From Baseline in Total IgE
Detect total IgE in serum by ImmunoCAP.
Time frame: Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FB825 | Change From Baseline in Total IgE | Dose 1 Day 8 | 482.93 IU/mL | Standard Deviation 1528.32 |
| FB825 | Change From Baseline in Total IgE | Dose 1 Day 15 | -137.70 IU/mL | Standard Deviation 1634.09 |
| FB825 | Change From Baseline in Total IgE | Dose 1 Day 29 | -298.07 IU/mL | Standard Deviation 1874.7 |
| FB825 | Change From Baseline in Total IgE | Dose 1 Day 57 | -862.73 IU/mL | Standard Deviation 1934.82 |
| FB825 | Change From Baseline in Total IgE | Dose 2 Day 85 | -1956.86 IU/mL | Standard Deviation 2880.48 |
| FB825 | Change From Baseline in Total IgE | Dose 2 Day 92 | -1581.65 IU/mL | Standard Deviation 2253.79 |
| FB825 | Change From Baseline in Total IgE | Dose 2 Day 99 | -1419.49 IU/mL | Standard Deviation 2901 |
| FB825 | Change From Baseline in Total IgE | Dose 2 Day 113 | -1968.97 IU/mL | Standard Deviation 2668.47 |
| FB825 | Change From Baseline in Total IgE | Dose 2 Day 141 | -2350.48 IU/mL | Standard Deviation 3023.13 |
| FB825 | Change From Baseline in Total IgE | Dose 2 Day 169/ EOS (end of study) | -2817.01 IU/mL | Standard Deviation 3708.34 |
Secondary
% Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis
BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient.
Time frame: Days 169
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis | -60.04 percentage change | Standard Deviation 26.41 |
Secondary
% Changes From Baseline in Eczema Area and Severity Index (EASI)
EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
Time frame: Day 169
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Eczema Area and Severity Index (EASI) | -72.14 percentage change | Standard Deviation 20.24 |
Secondary
% Changes From Baseline in Eczema Area and Severity Index (EASI)
EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
Time frame: Day 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Eczema Area and Severity Index (EASI) | -44.33 percentage change | Standard Deviation 41.88 |
Secondary
% Changes From Baseline in Eczema Area and Severity Index (EASI)
EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
Time frame: Day 57
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Eczema Area and Severity Index (EASI) | -68.09 percentage change | Standard Deviation 29.35 |
Secondary
% Changes From Baseline in Eczema Area and Severity Index (EASI)
EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
Time frame: Day 113
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Eczema Area and Severity Index (EASI) | -70.00 percentage change | Standard Deviation 34.2 |
Secondary
% Changes From Baseline in Eczema Area and Severity Index (EASI)
EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.
Time frame: Day 141
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Eczema Area and Severity Index (EASI) | -73.12 percentage change | Standard Deviation 25.32 |
Secondary
% Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis
IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient.
Time frame: Days 169
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis | -39.58 percentage change | Standard Deviation 19.5 |
Secondary
% Changes From Baseline in Irritability Visual Analogue Scale (VAS)
VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.
Time frame: Days 85
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Irritability Visual Analogue Scale (VAS) | -32.57 percentage change | Standard Deviation 30.23 |
Secondary
% Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)
SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.
Time frame: Days 169
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FB825 | % Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD) | -56.19 percentage change | Standard Deviation 15.72 |
Secondary
Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs)
Safety will be assessed by monitoring and recording of adverse events (AEs) and serious adverse event (SAEs); physical examination findings and vital sign measurements (systolic and diastolic blood pressures, heart rate, respiratory rate, and body temperature), clinical laboratory test results (hematology, coagulation, serum chemistry \[including liver function tests, blood glucose level\], and urinalysis); 12-lead ECG results.
Time frame: through study completion, an average of 1 year.