NCT06397911

Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Oneness Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy, pharmacokinetics, and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis.

Detailed description

This multicenter, randomized, double-blind, placebo-controlled, 2-arm, parallel-group study will enroll approximately 90 subjects with moderate-to-severe atopic dermatitis, with approximately 45 subjects per group. The study duration of subject participation in the study is up to 28 weeks, including up to 4 weeks for screening, a 12-week study intervention and a 12-week follow-up period after study intervention. The study treatment will be administered as 5 SC doses.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	FB825	The study treatment will be administered as 5 SC doses in total 12 weeks
DRUG	Placebo	The study treatment will be administered as 5 SC doses in total 12 weeks

Timeline

• Start date: 2024-08-08
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-05-03
• Last updated: 2025-09-22

Locations

16 sites across 2 countries: United States, Taiwan

Regulatory

• FDA-regulated drug study