Atopic DermatitisPhase 2NCT03758716
An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
A Phase 2 study testing FB825, FB825-15D11, Anti-CemX in people with Atopic Dermatitis, run by Fountain Biopharma Inc. at 1 site in Taiwan.
Trial summary
The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- FB825, FB825-15D11, Anti-CemX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 3 Jul 2017to 19 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the Safety and Efficacy of FB825 in Adults with Atopic Dermatitis
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- FB825, FB825-15D11, Anti-CemX
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FB825, FB825-15D11, Anti-CemXDrug
Also called FB825-15D11, Lot # 16-2056
Pharmaceutical form: 20mg/ml solution Route of administration: IV
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: FB825, FB825-15D11, Anti-CemX |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Change From Baseline in Total IgE
Detect total IgE in serum by ImmunoCAP.
Measured: Day 169
% Change From Baseline in Allergen-specific IgE
Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)
Measured: Day 169
Secondary outcomes (12)
Change From Baseline in Total IgE
Detect total IgE in serum by ImmunoCAP.
Measured: 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
Detect specific IgE in serum by ImmunoCAP. (Dog dander)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start3 Jul 2017
- Primary completion28 Jan 2019
- Study completion19 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fountain Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Yu Chu, MD-PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758716
- Sponsor's protocol ID
- FB825CLIIS-01-AD
- Status last verified
- Apr 2021
- First submitted
- 25 Nov 2018
- Last updated
- 22 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03758716
- Acronym / sponsor ID
- FB825CLIIS-01-AD
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Fountain Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2017 (actual)
- Primary completion
- 28 Jan 2019 (actual)
- Study completion
- 19 Sep 2019 (actual)
- First posted
- 29 Nov 2018 (actual)
- Results
- Posted 15 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FB825 | Experimental | Drug: FB825, FB825-15D11, Anti-CemXOnly 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FB825, FB825-15D11, Anti-CemXAlso: FB825-15D11, Lot # 16-2056Pharmaceutical form: 20mg/ml solution Route of administration: IV | Drug | FB825 |
Primary outcome
% Change From Baseline in Total IgE
Time frame: Day 169
Detect total IgE in serum by ImmunoCAP.
% Change From Baseline in Allergen-specific IgE
Time frame: Day 169
Detect specific IgE in serum by ImmunoCAP. (ex. Ragweed)
12 secondary outcomes
Change From Baseline in Total IgE
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)
% Change From Baseline in Allergen-specific IgE
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)
% Changes From Baseline in Irritability Visual Analogue Scale (VAS)
Time frame: Days 85
% Changes From Baseline in Eczema Area and Severity Index (EASI)
Time frame: Day 85
% Changes From Baseline in Severity Scoring of Atopic Dermatitis Index (SCORAD)
Time frame: Days 169
% Changes From Baseline in Investigator Global Assessment (IGA) for Atopic Dermatitis
Time frame: Days 169
% Changes From Baseline in Body Surface Area (BSA) Involved in Atopic Dermatitis
Time frame: Days 169
Safety Will be Assessed by Monitoring and Recording of Adverse Events (AEs) and Serious Adverse Event (SAEs)
Time frame: through study completion, an average of 1 year.
% Changes From Baseline in Eczema Area and Severity Index (EASI)
Time frame: Day 57
% Changes From Baseline in Eczema Area and Severity Index (EASI)
Time frame: Day 113
% Changes From Baseline in Eczema Area and Severity Index (EASI)
Time frame: Day 141
% Changes From Baseline in Eczema Area and Severity Index (EASI)
Time frame: Day 169
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chia-Yu Chu, MD-PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FB825, FB825-15D11, Anti-CemX in people with Atopic Dermatitis, run by Fountain Biopharma Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Change From Baseline in Total IgE (time frame: Day 169). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2021.