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

October 22, 2021 updated by: Forte Biosciences, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fremont, California, United States, 94538
        • Center for Dermatology Clinical Research, Inc.
    • Florida
      • Lake City, Florida, United States, 32055
        • Multi-Specialty Research Associates, Inc.
    • Georgia
      • Newnan, Georgia, United States, 30263
        • MedaPhase, Inc
    • Indiana
      • Clarksville, Indiana, United States, 47129
        • DS Research
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • DS Research
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Cyn3rgy Research
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research
    • Texas
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FB-401
FB-401 applied topically
Biological: FB-401
Topical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 52 weeks
Safety evaluations
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Forte Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

June 15, 2021

First Submitted That Met QC Criteria

June 15, 2021

First Posted (Actual)

June 23, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FB401-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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