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Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04504279
Recruitment Status : Completed
First Posted : August 7, 2020
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Forte Biosciences, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: FB-401 Biological: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : October 13, 2020
Actual Primary Completion Date : July 14, 2021
Actual Study Completion Date : August 19, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: FB-401
FB-401 applied topically for 16 weeks.
 Biological: FB-401
Topical application
Placebo Comparator: Placebo
Placebo applied topically for 16 weeks.
 Biological: Placebo
Vehicle


Outcome Measures
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Primary Outcome Measures :
  1. EASI 50 [ Time Frame: 16 weeks ]
    The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16


Secondary Outcome Measures :
  1. Includes percent change in EASI [ Time Frame: 16 weeks ]
    Percent change in EASI score is measured from baseline to Week 16


Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504279


Locations
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United States, California
First OC Dermatology
Fountain Valley, California, United States, 92708
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
United States, Florida
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States, 32055
United States, Georgia
MedaPhase, Inc.
Newnan, Georgia, United States, 30263
United States, Indiana
DS Research
Clarksville, Indiana, United States, 47129
The Indiana Clinical Trials Center
Plainfield, Indiana, United States, 46168
United States, Kentucky
DS Research
Louisville, Kentucky, United States, 40241
United States, Maryland
Lawrence J. Green MD LLC
Rockville, Maryland, United States, 20850
United States, Minnesota
Minnesota Clinical Study Center
New Brighton, Minnesota, United States, 55112
United States, Nebraska
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States, 68516
United States, North Carolina
Dermatology Consulting Services, PLLC
High Point, North Carolina, United States, 27262
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
United States, Pennsylvania
KGL Skin Study Center LLC
Newtown Square, Pennsylvania, United States, 19073
United States, Texas
Bellaire Dermatology Associates
Bellaire, Texas, United States, 77401
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Sponsors and Collaborators
Forte Biosciences, Inc.
More Information
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Publications:

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Responsible Party: Forte Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04504279    
Other Study ID Numbers: FB401-01
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Forte Biosciences, Inc.:
atopic dermatitis
microbiome
probiotic
commensal Gram-negative bacteria
transdermal water loss
allergic diseases
 dermatitis
eczema
skin diseases
skin diseases, eczematous
immune system diseases
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases