Study Stopped
Failure of the Phase 2 study (protocol FB401-01) to meet its endpoint.
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
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
1 other identifier
interventional
36
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2021
Shorter than P25 for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2021
CompletedFirst Submitted
Initial submission to the registry
June 15, 2021
CompletedFirst Posted
Study publicly available on registry
June 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedOctober 28, 2021
October 1, 2021
4 months
June 15, 2021
October 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of adverse events
Safety evaluations
52 weeks
Study Arms (1)
FB-401
EXPERIMENTALFB-401 applied topically
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Center for Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Multi-Specialty Research Associates, Inc.
Lake City, Florida, 32055, United States
MedaPhase, Inc
Newnan, Georgia, 30263, United States
DS Research
Clarksville, Indiana, 47129, United States
DS Research
Louisville, Kentucky, 40241, United States
Cyn3rgy Research
New Brighton, Minnesota, 55112, United States
Cyn3rgy Research
Gresham, Oregon, 97030, United States
Bellaire Dermatology Associates
Bellaire, Texas, 77401, United States
Related Publications (1)
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.
PMID: 29720571BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2021
First Posted
June 23, 2021
Study Start
June 2, 2021
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
October 28, 2021
Record last verified: 2021-10