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NCT04936113 Clinical 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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04936113
Other study ID # FB401-02
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date June 2, 2021
Est. completion date September 30, 2021

Study information
Verified date October 2021
Source Forte Biosciences, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 36
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• FB-401
Topical

Locations
Country Name City State
United States Bellaire Dermatology Associates Bellaire Texas
United States DS Research Clarksville Indiana
United States Center for Dermatology Clinical Research, Inc. Fremont California
United States Cyn3rgy Research Gresham Oregon
United States Multi-Specialty Research Associates, Inc. Lake City Florida
United States DS Research Louisville Kentucky
United States Cyn3rgy Research New Brighton Minnesota
United States MedaPhase, Inc Newnan Georgia

Sponsors (1)
Lead Sponsor Collaborator
Forte Biosciences, Inc.

Country where clinical trial is conducted

United States, 

References & 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). pii: 120608. doi: 10.1172/jci.insight.120608. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of adverse events Safety evaluations 52 weeks
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