Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
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ClinicalTrials.gov Identifier: NCT04504279 |
Recruitment Status :
Completed
First Posted : August 7, 2020
Last Update Posted : September 16, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Biological: FB-401 Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 154 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | October 13, 2020 |
Actual Primary Completion Date : | July 14, 2021 |
Actual Study Completion Date : | August 19, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: FB-401
FB-401 applied topically for 16 weeks.
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Biological: FB-401
Topical application |
Placebo Comparator: Placebo
Placebo applied topically for 16 weeks.
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Biological: Placebo
Vehicle |
- 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
- Includes percent change in EASI [ Time Frame: 16 weeks ]Percent change in EASI score is measured from baseline to Week 16

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04504279
United States, California | |
First OC Dermatology | |
Fountain Valley, California, United States, 92708 | |
Center for Dermatology Clinical Research, Inc. | |
Fremont, California, United States, 94538 | |
United States, Florida | |
Multi-Specialty Research Associates, Inc. | |
Lake City, Florida, United States, 32055 | |
United States, Georgia | |
MedaPhase, Inc. | |
Newnan, Georgia, United States, 30263 | |
United States, Indiana | |
DS Research | |
Clarksville, Indiana, United States, 47129 | |
The Indiana Clinical Trials Center | |
Plainfield, Indiana, United States, 46168 | |
United States, Kentucky | |
DS Research | |
Louisville, Kentucky, United States, 40241 | |
United States, Maryland | |
Lawrence J. Green MD LLC | |
Rockville, Maryland, United States, 20850 | |
United States, Minnesota | |
Minnesota Clinical Study Center | |
New Brighton, Minnesota, United States, 55112 | |
United States, Nebraska | |
Midwest Children's Health Research Institute | |
Lincoln, Nebraska, United States, 68516 | |
United States, North Carolina | |
Dermatology Consulting Services, PLLC | |
High Point, North Carolina, United States, 27262 | |
United States, Oregon | |
Cyn3rgy Research | |
Gresham, Oregon, United States, 97030 | |
United States, Pennsylvania | |
KGL Skin Study Center LLC | |
Newtown Square, Pennsylvania, United States, 19073 | |
United States, Texas | |
Bellaire Dermatology Associates | |
Bellaire, Texas, United States, 77401 | |
Texas Dermatology and Laser Specialists | |
San Antonio, Texas, United States, 78218 |
Responsible Party: | Forte Biosciences, Inc. |
ClinicalTrials.gov Identifier: | NCT04504279 |
Other Study ID Numbers: |
FB401-01 |
First Posted: | August 7, 2020 Key Record Dates |
Last Update Posted: | September 16, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
atopic dermatitis microbiome probiotic commensal Gram-negative bacteria transdermal water loss allergic diseases |
dermatitis eczema skin diseases skin diseases, eczematous immune system diseases |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |