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Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study

Primary Purpose

Atopic Dermatitis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FB-401
Sponsored by
Forte Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study
  • Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor

Exclusion Criteria:

  • Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01
  • Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological
  • Pregnant (or planning to become pregnant during the period of the study) or lactating females

Sites / Locations

  • Center for Dermatology Clinical Research, Inc.
  • Multi-Specialty Research Associates, Inc.
  • MedaPhase, Inc
  • DS Research
  • DS Research
  • Cyn3rgy Research
  • Cyn3rgy Research
  • Bellaire Dermatology Associates

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FB-401

Arm Description

FB-401 applied topically

Outcomes

Primary Outcome Measures

Number of adverse events
Safety evaluations

Secondary Outcome Measures

Full Information

First Posted
June 15, 2021
Last Updated
October 22, 2021
Sponsor
Forte Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04936113
Brief Title
Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study
Official Title
An Open-Label, Multicenter Study to Evaluate Continued Safety of FB-401 for up to 48 Weeks in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in FB401-01 Phase 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
Failure of the Phase 2 study (protocol FB401-01) to meet its endpoint.
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 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 continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.

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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FB-401
Arm Type
Experimental
Arm Description
FB-401 applied topically
Intervention Type
Biological
Intervention Name(s)
FB-401
Intervention Description
Topical
Primary Outcome Measure Information:
Title
Number of adverse events
Description
Safety evaluations
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participated in Protocol FB401-01, completed through Week 20 visit and able to directly enroll into this (FB401-02) study Refrain from use of all other atopic dermatitis treatments, unless given permission by medical monitor Exclusion Criteria: Subject experienced a serious adverse event or severe adverse event attributable to study drug in Protocol FB401-01 Severe concomitant illness that, in the Investigator's opinion, would adversely affect subject participation in the study, whether medical or psychological Pregnant (or planning to become pregnant during the period of the study) or lactating females
Facility Information:
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
DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Cyn3rgy Research
City
New Brighton
State/Province
Minnesota
ZIP/Postal Code
55112
Country
United States
Facility Name
Cyn3rgy Research
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Bellaire Dermatology Associates
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States

12. IPD Sharing Statement

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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Learn more about this trial

Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study

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