NCT04413942

Evaluate Efficacy, PK, and Safety of FB825 in Adults With Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Multiple Intravenous Doses of FB825 in Adults With Atopic Dermatitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the efficacy, improvement from baseline in Eczema Area and Severity Index (EASI) score, of multiple intravenous (IV) doses of FB825 in subjects with atopic dermatitis

Detailed description

IgE plays an important role in mediating hypersensitivity reactions responsible for most of the allergic diseases, such as atopic dermatitis, asthma etc. which remain poorly controlled. FB825 blocks the biological pathway of IgE synthesis and thus can be used to treat IgE-mediated allergic diseases. FB825 was found to be safe when given IV repeat dose in toxicology study in monkey. No adverse effects of FB825 were observed in parameters included electrocardiograms for cardiovascular, ophthalmic examinations and other clinical, CNS and respiratory safety observations. The safety and tolerability of FB825 was demonstrated in the US phase I randomized, double-blind study with healthy subjects. Also, the FB825 was proved by in vivo study that it is able to block the biological pathway of IgE synthesis and thus can be used to treat IgE-mediated allergic diseases. Therefore, in this study, the effects of IgE in patients with atopic dermatitis receiving FB825 treatment will be investigated. The study will evaluate safety and efficacy in adults with atopic dermatitis.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
BIOLOGICAL	FB825	Humanized monoclonal IgG1 specifically targeting the CεmX domain of membrane-bound IgE
OTHER	Placebo	Formulation buffer

Timeline

• Start date: 2020-03-10
• Primary completion: 2021-12-31
• Completion: 2022-06-30
• First posted: 2020-06-04
• Last updated: 2022-04-04

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated drug study