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

Forte Biosciences

Status and phase: Terminated; Phase 2

Conditions: Atopic Dermatitis

Treatments: Biological: FB-401

Study type: Interventional

Funder types: Industry

Identifiers

NCT04936113

FB401-02

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 2+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

FB-401

Experimental group

Description:

FB-401 applied topically

Treatment:

Biological: FB-401