Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis

September 14, 2021 updated by: Forte Biosciences, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescent and Adult Subjects (Ages 2 Years and Older) With Mild to Moderate Atopic Dermatitis

The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs and symptoms following the application of FB-401 in patients 2 years or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will be assessed by assessment of the skin and patient reports.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

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
      • Fountain Valley, California, United States, 92708
        • First OC Dermatology
      • 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
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • DS Research
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence J. Green MD LLC
    • Minnesota
      • New Brighton, Minnesota, United States, 55112
        • Minnesota Clinical Study Center
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Midwest Children's Health Research Institute
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services, PLLC
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research
    • Pennsylvania
      • Newtown Square, Pennsylvania, United States, 19073
        • KGL Skin Study Center LLC
    • Texas
      • Bellaire, Texas, United States, 77401
        • Bellaire Dermatology Associates
      • San Antonio, Texas, United States, 78218
        • Texas Dermatology and Laser Specialists

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

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, ≥ 2 years of age
  • Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit
  • Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baseline/Day 1 using the validated IGA scale for atopic dermatitis
  • EASI score ≥ 5 at the screening and the Baseline visit
  • 5% to 30% (inclusive) body surface area of atopic dermatitis involvement at the screening and the baseline visit

Exclusion Criteria:

  • Previous treatment within 4 weeks prior to the baseline visit with any of the following:
  • Immunosuppressive or immunomodulating systemic drugs such as systemic (intravenous, oral, intra-articular or intramuscular) corticosteroids, azathioprine, methotrexate, cyclosporine
  • Phototherapy or photo chemotherapy for atopic dermatitis
  • Previous treatment within 1 week prior to the baseline visit with any of the following:
  • Topical corticosteroids (does not include inhaled, intranasal or ophthalmic) or topical calcineurin inhibitors
  • Topical phosphodiesterase type 4 (PDE4) inhibitor
  • Use of emollients other than provided for the study
  • Bleach baths
  • Within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the baseline visit with Janus kinase inhibitors or other investigational drug
  • Within16 weeks or 5 half-lives, whichever is longer, prior to the baseline visit with dupilumab or other biologic agent to treat atopic dermatitis
  • Within 1 year prior to the baseline visit with any live bacterial therapy
  • 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FB-401
FB-401 applied topically for 16 weeks.
Biological: FB-401
Topical application
Placebo Comparator: Placebo
Placebo applied topically for 16 weeks.
Biological: Placebo
Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EASI 50
Time Frame: 16 weeks
The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Includes percent change in EASI
Time Frame: 16 weeks
Percent change in EASI score is measured from baseline to Week 16
16 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)

October 13, 2020

Primary Completion (Actual)

July 14, 2021

Study Completion (Actual)

August 19, 2021

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 14, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FB401-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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