NCT04504279

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

Completed Phase 2 Last updated 16 September 2021

What this trial tests

Phase 2 trial testing FB-401 in Atopic Dermatitis in 154 participants. Completed in 19 August 2021.

Timeline

13 October 2020

Primary endpoint
14 July 2021

19 August 2021

Quick facts

Lead sponsor	Forte Biosciences, Inc.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	154
Start date	13 October 2020
Primary completion	14 July 2021
Estimated completion	19 August 2021
Sites	15 locations across United States

Drugs / interventions tested

• FB-401 — full drug profile →
• Placebo

Conditions studied

• Atopic Dermatitis — all drugs for Atopic Dermatitis →

Sponsor

Forte Biosciences, Inc. — full company profile →

Who can join

2 and older, any sex, with Atopic Dermatitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Atopic dermatitis: an expanding therapeutic pipeline for a complex disease.
   Bieber T. · · 2022 · cited 421× · PMID 34417579 · DOI 10.1038/s41573-021-00266-6
2. Exposure to isocyanates predicts atopic dermatitis prevalence and disrupts therapeutic pathways in commensal bacteria.
   Zeldin J, Chaudhary PP, Spathies J, Yadav M, et al · · 2023 · cited 29× · PMID 36608129 · DOI 10.1126/sciadv.ade8898
3. Unraveling Atopic Dermatitis: Insights into Pathophysiology, Therapeutic Advances, and Future Perspectives.
   Pareek A, Kumari L, Pareek A, Chaudhary S, et al · · 2024 · cited 27× · PMID 38474389 · DOI 10.3390/cells13050425
4. Novel Therapeutic Strategies in the Topical Treatment of Atopic Dermatitis.
   Pinto LM, Chiricozzi A, Calabrese L, Mannino M, et al · · 2022 · cited 17× · PMID 36559261 · DOI 10.3390/pharmaceutics14122767
5. A Systematic Review of Atopic Dermatitis: The Intriguing Journey Starting from Physiopathology to Treatment, from Laboratory Bench to Bedside.
   Radi G, Campanti A, Diotallevi F, Martina E, et al · · 2022 · cited 17× · PMID 36359220 · DOI 10.3390/biomedicines10112700
6. A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 16-Week Trial to Evaluate the Efficacy and Safety of FB-401 in Children, Adolescents, and Adult Subjects (Ages 2 Years and Older) with Mild-to-Moderate Atopic Dermatitis.
   Jacobson ME, Myles IA, Paller AS, Eichenfield LF, et al · · 2024 · cited 13× · PMID 37579728 · DOI 10.1159/000532054
7. Bacterial live therapeutics for human diseases.
   Frutos-Grilo E, Ana Y, Gonzalez-de Miguel J, Cardona-I-Collado M, et al · · 2024 · cited 6× · PMID 39443745 · DOI 10.1038/s44320-024-00067-0
8. Advancing Therapeutic Strategies in Atopic Dermatitis: Emerging Targets and Personalized Approaches.
   Lo Y, Cheng TT, Huang CJ, Cheng YC, et al · · 2025 · cited 5× · PMID 40563478 · DOI 10.3390/biom15060838