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The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FB825 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FB825, FB825-15D11, Anti-CemX | Drug | Pharmaceutical form: 20mg/ml solution Route of administration: IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| % Change From Baseline in Total IgE | Detect total IgE in serum by ImmunoCAP. | Day 169 |
| % Change From Baseline in Allergen-specific IgE | Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed) | Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total IgE | Detect total IgE in serum by ImmunoCAP. | Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825) |
| % Change From Baseline in Allergen-specific IgE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chia-Yu Chu, MD-PhD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | % Change From Baseline in Total IgE | Detect total IgE in serum by ImmunoCAP. | Posted | Mean | Standard Deviation | percentage change | Day 169 |
|
|
169 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| NienYi Chen PhD | Oneness Biotech Co., Ltd. | +886 2 2655 8687 | 613 | nienyichen@onenessbio.com.tw |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2018 | Feb 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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Detect specific IgE in serum by ImmunoCAP. (Dog dander)
| Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825) |
| % 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. | Days 85 |
| % 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. | Day 85 |
| % 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. | Days 169 |
| % 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. | Days 169 |
| % 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. | Days 169 |
| 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. | through study completion, an average of 1 year. |
| % 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. | Day 57 |
| % 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. | Day 113 |
| % 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. | Day 141 |
| % 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. | Day 169 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Total IgE | Total IgE (immunoglobulin E) | Mean | Standard Deviation | IU/mL |
|
| EASI Scores | EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient. | Mean | Standard Deviation | units on a scale |
|
|
| Primary | % Change From Baseline in Allergen-specific IgE | Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed) | Posted | Mean | Standard Deviation | percentage change | Day 169 |
|
|
|
| Secondary | Change From Baseline in Total IgE | Detect total IgE in serum by ImmunoCAP. | Posted | Mean | Standard Deviation | IU/mL | Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825) |
|
|
|
| Secondary | % Change From Baseline in Allergen-specific IgE | Detect specific IgE in serum by ImmunoCAP. (Dog dander) | Posted | Mean | Standard Deviation | percentage change | Day 8, 15, 29, 57, and day 85 (And Day 92, 99, 113, 141 and 169 if received the second dose of FB825) |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change | Days 85 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change | Day 85 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change | Days 169 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change | Days 169 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change | Days 169 |
|
|
|
| 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. | Not Posted | through study completion, an average of 1 year. | Participants |
| 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. | Posted | Mean | Standard Deviation | percentage change | Day 57 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change | Day 113 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change | Day 141 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percentage change | Day 169 |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 9 |
| 12 |
| Herpes simplex | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 21.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.1 | Non-systematic Assessment |
|
| Scratch | Injury, poisoning and procedural complications | MedDRA 21.1 | Non-systematic Assessment |
|
| Electrocardiogram QT prolonged | Investigations | MedDRA 21.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Non-systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Dose 1 Day 57 |
|
| Dose 2 Day 85 |
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| Dose 2 Day 92 |
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| Dose 2 Day 99 |
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| Dose 2 Day 113 |
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| Dose 2 Day 141 |
|
| Dose 2 Day 169/ EOS (end of study) |
|
| Title | Measurements |
|---|---|
|
| Dose 1 Day 57 |
|
| Dose 2 Day 85 |
|
| Dose 2 Day 92 |
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| Dose 2 Day 99 |
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| Dose 2 Day 113 |
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| Dose 2 Day 141 |
|
| Dose 2 Day 169/ EOS |
|