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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04504279
• Other study ID #: FB401-01
• Status: Completed
• Phase: Phase 2
• Start date: October 13, 2020
• Est. completion date: August 19, 2021

Study information

• Verified date: September 2021
• Source: Forte Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 19, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• FB-401
Topical application
• Placebo
Vehicle

Locations

Country	Name	City	State
United States	Bellaire Dermatology Associates	Bellaire	Texas
United States	DS Research	Clarksville	Indiana
United States	First OC Dermatology	Fountain Valley	California
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	Cyn3rgy Research	Gresham	Oregon
United States	Dermatology Consulting Services, PLLC	High Point	North Carolina
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Midwest Children's Health Research Institute	Lincoln	Nebraska
United States	DS Research	Louisville	Kentucky
United States	Minnesota Clinical Study Center	New Brighton	Minnesota
United States	MedaPhase, Inc.	Newnan	Georgia
United States	KGL Skin Study Center LLC	Newtown Square	Pennsylvania
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
United States	Lawrence J. Green MD LLC	Rockville	Maryland
United States	Texas Dermatology and Laser Specialists	San Antonio	Texas

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	EASI 50	The proportion of subjects with 50% improvement in Eczema Area and Severity Index (EASI) score from baseline at Week 16	16 weeks
Secondary	Includes percent change in EASI	Percent change in EASI score is measured from baseline to Week 16	16 weeks