Back to resultsEvaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FB-401
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, microbiome, probiotic, commensal Gram-negative bacteria, transdermal water loss, allergic diseases, dermatitis, eczema, skin diseases, skin diseases, eczematous, immune system diseases
Eligibility Criteria
Inclusion Criteria:
- Male or female, ≥ 2 years of age
- Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit
- Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baseline/Day 1 using the validated IGA scale for atopic dermatitis
- EASI score ≥ 5 at the screening and the Baseline visit
- 5% to 30% (inclusive) body surface area of atopic dermatitis involvement at the screening and the baseline visit
Exclusion Criteria:
- Previous treatment within 4 weeks prior to the baseline visit with any of the following:
- Immunosuppressive or immunomodulating systemic drugs such as systemic (intravenous, oral, intra-articular or intramuscular) corticosteroids, azathioprine, methotrexate, cyclosporine
- Phototherapy or photo chemotherapy for atopic dermatitis
- Previous treatment within 1 week prior to the baseline visit with any of the following:
- Topical corticosteroids (does not include inhaled, intranasal or ophthalmic) or topical calcineurin inhibitors
- Topical phosphodiesterase type 4 (PDE4) inhibitor
- Use of emollients other than provided for the study
- Bleach baths
- Within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the baseline visit with Janus kinase inhibitors or other investigational drug
- Within16 weeks or 5 half-lives, whichever is longer, prior to the baseline visit with dupilumab or other biologic agent to treat atopic dermatitis
- Within 1 year prior to the baseline visit with any live bacterial therapy
- Pregnant (or planning to become pregnant during the period of the study) or lactating females
Sites / Locations
- First OC Dermatology
- Center for Dermatology Clinical Research, Inc.
- Multi-Specialty Research Associates, Inc.
- MedaPhase, Inc.
- DS Research
- The Indiana Clinical Trials Center
- DS Research
- Lawrence J. Green MD LLC
- Minnesota Clinical Study Center
- Midwest Children's Health Research Institute
- Dermatology Consulting Services, PLLC
- Cyn3rgy Research
- KGL Skin Study Center LLC
- Bellaire Dermatology Associates
- Texas Dermatology and Laser Specialists
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
FB-401
Placebo
Arm Description
FB-401 applied topically for 16 weeks.
Placebo applied topically for 16 weeks.
Outcomes
Primary Outcome Measures
EASI 50
The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
Secondary Outcome Measures
Includes percent change in EASI
Percent change in EASI score is measured from baseline to Week 16
Full Information
NCT ID
NCT04504279
First Posted
August 5, 2020
Last Updated
September 14, 2021
Sponsor
Forte Biosciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04504279
Brief Title
Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 13, 2020 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
August 19, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forte Biosciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs and symptoms following the application of FB-401 in patients 2 years or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will be assessed by assessment of the skin and patient reports.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, microbiome, probiotic, commensal Gram-negative bacteria, transdermal water loss, allergic diseases, dermatitis, eczema, skin diseases, skin diseases, eczematous, immune system diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FB-401
Arm Type
Experimental
Arm Description
FB-401 applied topically for 16 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo applied topically for 16 weeks.
Intervention Type
Biological
Intervention Name(s)
FB-401
Intervention Description
Topical application
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
EASI 50
Description
The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Includes percent change in EASI
Description
Percent change in EASI score is measured from baseline to Week 16
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female, ≥ 2 years of age
Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit
Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baseline/Day 1 using the validated IGA scale for atopic dermatitis
EASI score ≥ 5 at the screening and the Baseline visit
5% to 30% (inclusive) body surface area of atopic dermatitis involvement at the screening and the baseline visit
Exclusion Criteria:
Previous treatment within 4 weeks prior to the baseline visit with any of the following:
Immunosuppressive or immunomodulating systemic drugs such as systemic (intravenous, oral, intra-articular or intramuscular) corticosteroids, azathioprine, methotrexate, cyclosporine
Phototherapy or photo chemotherapy for atopic dermatitis
Previous treatment within 1 week prior to the baseline visit with any of the following:
Topical corticosteroids (does not include inhaled, intranasal or ophthalmic) or topical calcineurin inhibitors
Topical phosphodiesterase type 4 (PDE4) inhibitor
Use of emollients other than provided for the study
Bleach baths
Within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the baseline visit with Janus kinase inhibitors or other investigational drug
Within16 weeks or 5 half-lives, whichever is longer, prior to the baseline visit with dupilumab or other biologic agent to treat atopic dermatitis
Within 1 year prior to the baseline visit with any live bacterial therapy
Pregnant (or planning to become pregnant during the period of the study) or lactating females
Facility Information:
Facility Name
First OC Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Center for Dermatology Clinical Research, Inc.
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Multi-Specialty Research Associates, Inc.
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
MedaPhase, Inc.
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
DS Research
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Facility Name
The Indiana Clinical Trials Center
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Lawrence J. Green MD LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Minnesota Clinical Study Center
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Midwest Children's Health Research Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Dermatology Consulting Services, PLLC
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
KGL Skin Study Center LLC
City
Newtown Square
State/Province
Pennsylvania
ZIP/Postal Code
19073
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29720571
Citation
Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.
Results Reference
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Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
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