NCT04936113 is a Phase 2 clinical trial of FB-401 in Atopic Dermatitis, sponsored by Forte Biosciences, Inc..

Who is sponsoring NCT04936113?

NCT04936113 is sponsored by Forte Biosciences, Inc..

What drugs are being tested in NCT04936113?

Interventions in NCT04936113: FB-401.

What condition does NCT04936113 study?

NCT04936113 studies Atopic Dermatitis.

Is NCT04936113 still recruiting?

NCT04936113 is currently terminated. Last updated 28 October 2021.

Last reviewed 2021-10-28 · How we verify

NCT04936113

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Continued Safety Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis Previously Enrolled in the FB401-01 Study

Terminated Phase 2 Last updated 28 October 2021

What this trial tests

Phase 2 trial testing FB-401 in Atopic Dermatitis in 36 participants. Terminated before completion.

Timeline

2 June 2021

Primary endpoint
30 September 2021

30 September 2021

Quick facts

Lead sponsor	Forte Biosciences, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	2 June 2021
Primary completion	30 September 2021
Estimated completion	30 September 2021
Sites	8 locations across United States

Drugs / interventions tested

FB-401 — full drug profile →

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 continued safety and tolerability of FB-401 in subjects 2 years of age or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for up to 48 additional weeks and subjects will be evaluated for safety.

Publications & conference data

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

The skin microbiome in pediatric atopic dermatitis and food allergy.
Tham EH, Chia M, Riggioni C, Nagarajan N, et al · · 2024 · cited 18× · PMID 38308490 · DOI 10.1111/all.16044
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
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

Verify or expand the search:

Other trials of FB-401

Trials testing the same drug.

NCT04504279 — Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis · Phase 2 · completed

Other recruiting trials for Atopic Dermatitis

Currently open trials in the same condition.

NCT07262983 — Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopi · Phase 1 · recruiting
NCT07445919 — A Clinical Study to Evaluate SM17 for Atopic Dermatitis · Phase 2 · recruiting
NCT07488065 — A Study of SKB575 (HBM7575) Injection in Healthy Participants and Atopic Dermatitis Participants · Phase 1 · recruiting
NCT07467564 — The Impact of Dupilumab Treatment on Anxiety and Depression Symptoms in Patients With Moderate-to-Severe Atopic Dermatit · recruiting
NCT07358156 — A Study to Compare the Pharmacokinetics, Pharmacodynamic, Immunogenicity, and Safety of CKD-706 With US-Dupixent®, and E · Phase 1 · recruiting

Other Forte Biosciences, Inc. trials

Trials by the same sponsor.

NCT07205159 — A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Severe to Very Severe Alopecia Areata. · Phase 1 · recruiting
NCT06982963 — Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease · Phase 2 · recruiting
NCT06905873 — A Study to Evaluate the Safety and Efficacy of FB102 in Patients With Non-segmental Vitiligo · Phase 1 · recruiting
NCT04504279 — Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04936113 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Forte Biosciences, Inc.
Last refreshed: 28 October 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04936113.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing