NCT05004324

Safety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD)

A Two-stage, Multi-center, Randomized, Double-Blind, Placebo Controlled, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 308 (estimated)
• Sponsor: Kang Stem Biotech Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial study is two-stage, multi-center, randomized, double-blind, placebo controlled, phase 3 clinical trial to evaluate the efficacy and safety of FURESTEM-AD Inj. for moderate to severe chronic atopic dermatitis.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
BIOLOGICAL	FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL	the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)
BIOLOGICAL	Placebo	the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)

Timeline

• Start date: 2021-06-29
• Primary completion: 2023-01-01
• Completion: 2023-04-01
• First posted: 2021-08-13
• Last updated: 2021-08-13

Locations

1 site across 1 country: South Korea