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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04936113

Enrollment

Registered

2021-06-23

Start date

2021-06-02

Completion date

2021-09-30

Last updated

2021-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BIOLOGICALFB-401

Topical

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Number of adverse events	52 weeks	Safety evaluations

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026