Status:
COMPLETED
Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Forte Biosciences, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
2+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2021
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04504279
Start Date
October 13 2020
End Date
August 19 2021
Last Update
September 16 2021
Active Locations (15)
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1
First OC Dermatology
Fountain Valley, California, United States, 92708
2
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States, 94538
3
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States, 32055
4
MedaPhase, Inc.
Newnan, Georgia, United States, 30263