Trial Outcomes & Findings for An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis (NCT NCT03758716)

Results Overview

Detect total IgE in serum by ImmunoCAP.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

12 participants

Primary outcome timeframe

Day 169

Results posted on

2021-04-22

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FB825 n=12 Participants 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
Age, Continuous	30.75 years STANDARD_DEVIATION 6.88 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Taiwan	12 participants n=5 Participants
Total IgE	6611.53 IU/mL STANDARD_DEVIATION 6693.41 • n=5 Participants
EASI Scores	25.98 units on a scale STANDARD_DEVIATION 8.34 • n=5 Participants

PRIMARY outcome

Timeframe: Day 169

Detect total IgE in serum by ImmunoCAP.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Change From Baseline in Total IgE	-45.57 percentage change Standard Deviation 21.27

PRIMARY outcome

Timeframe: Day 169

Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Change From Baseline in Allergen-specific IgE	-50.16 percentage change Standard Deviation 23.61

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
Change From Baseline in Total IgE Dose 1 Day 8	482.93 IU/mL Standard Deviation 1528.32
Change From Baseline in Total IgE Dose 1 Day 15	-137.70 IU/mL Standard Deviation 1634.09
Change From Baseline in Total IgE Dose 1 Day 29	-298.07 IU/mL Standard Deviation 1874.70
Change From Baseline in Total IgE Dose 1 Day 57	-862.73 IU/mL Standard Deviation 1934.82
Change From Baseline in Total IgE Dose 2 Day 85	-1956.86 IU/mL Standard Deviation 2880.48
Change From Baseline in Total IgE Dose 2 Day 92	-1581.65 IU/mL Standard Deviation 2253.79
Change From Baseline in Total IgE Dose 2 Day 99	-1419.49 IU/mL Standard Deviation 2901.00
Change From Baseline in Total IgE Dose 2 Day 113	-1968.97 IU/mL Standard Deviation 2668.47
Change From Baseline in Total IgE Dose 2 Day 141	-2350.48 IU/mL Standard Deviation 3023.13
Change From Baseline in Total IgE Dose 2 Day 169/ EOS (end of study)	-2817.01 IU/mL Standard Deviation 3708.34

SECONDARY outcome

Timeframe: 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)

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Change From Baseline in Allergen-specific IgE Dose 2 Day 85	-25.44 percentage change Standard Deviation 15.01
% Change From Baseline in Allergen-specific IgE Dose 1 Day 8	-1.88 percentage change Standard Deviation 12.87
% Change From Baseline in Allergen-specific IgE Dose 1 Day 15	-5.81 percentage change Standard Deviation 17.92
% Change From Baseline in Allergen-specific IgE Dose 1 Day 29	-4.83 percentage change Standard Deviation 21.74
% Change From Baseline in Allergen-specific IgE Dose 1 Day 57	-22.38 percentage change Standard Deviation 20.98
% Change From Baseline in Allergen-specific IgE Dose 2 Day 92	-33.22 percentage change Standard Deviation 17.42
% Change From Baseline in Allergen-specific IgE Dose 2 Day 99	-36.30 percentage change Standard Deviation 17.80
% Change From Baseline in Allergen-specific IgE Dose 2 Day 113	-35.02 percentage change Standard Deviation 16.81
% Change From Baseline in Allergen-specific IgE Dose 2 Day 141	-44.07 percentage change Standard Deviation 16.40
% Change From Baseline in Allergen-specific IgE Dose 2 Day 169/ EOS	-46.94 percentage change Standard Deviation 15.02

SECONDARY outcome

Timeframe: Days 85

VAS measurement follow the normal by Principal Investigator, range from 0-20. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Irritability Visual Analogue Scale (VAS)	-32.57 percentage change Standard Deviation 30.23

SECONDARY outcome

Timeframe: Day 85

EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Eczema Area and Severity Index (EASI)	-44.33 percentage change Standard Deviation 41.88

SECONDARY outcome

Timeframe: Days 169

SCORAD measurement follow the normal by Principal Investigator, range from 0-103. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)	-56.19 percentage change Standard Deviation 15.72

SECONDARY outcome

Timeframe: Days 169

IGA measurement follow the normal by Principal Investigator, range from 0-4. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis	-39.58 percentage change Standard Deviation 19.50

SECONDARY outcome

Timeframe: Days 169

BSA measurement follow the normal by Principal Investigator, range from 0-100. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis	-60.04 percentage change Standard Deviation 26.41

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 57

EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Eczema Area and Severity Index (EASI)	-68.09 percentage change Standard Deviation 29.35

SECONDARY outcome

Timeframe: Day 113

EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Eczema Area and Severity Index (EASI)	-70.00 percentage change Standard Deviation 34.20

SECONDARY outcome

Timeframe: Day 141

EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Eczema Area and Severity Index (EASI)	-73.12 percentage change Standard Deviation 25.32

SECONDARY outcome

Timeframe: Day 169

EASI measurement follow the normal by Principal Investigator. range from 0-72. The lower the scores the better situation of the patient.

Outcome measures

Outcome measures
Measure	FB825 n=12 Participants 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
% Changes From Baseline in Eczema Area and Severity Index (EASI)	-72.14 percentage change Standard Deviation 20.24

Adverse Events

FB825

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	FB825 n=12 participants at risk 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
Infections and infestations Upper respiratory tract infection	33.3% 4/12 • Number of events 4 • 169 days
Infections and infestations Herpes simplex	8.3% 1/12 • Number of events 1 • 169 days
Infections and infestations Herpes zoster	8.3% 1/12 • Number of events 1 • 169 days
Respiratory, thoracic and mediastinal disorders Asthma	8.3% 1/12 • Number of events 1 • 169 days
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Number of events 1 • 169 days
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.3% 1/12 • Number of events 1 • 169 days
Eye disorders Conjunctivitis allergic	8.3% 1/12 • Number of events 1 • 169 days
General disorders Pyrexia	8.3% 1/12 • Number of events 1 • 169 days
Injury, poisoning and procedural complications Scratch	8.3% 1/12 • Number of events 1 • 169 days
Investigations Electrocardiogram QT prolonged	8.3% 1/12 • Number of events 1 • 169 days
Skin and subcutaneous tissue disorders Eczema	8.3% 1/12 • Number of events 1 • 169 days

Additional Information

NienYi Chen PhD

Oneness Biotech Co., Ltd.

Phone: +886 2 2655 8687

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60