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ACTIVE NOT RECRUITING
NCT04137562
PHASE2

Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

Sponsor: EHL Bio Co., Ltd.

View on ClinicalTrials.gov

Summary

A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis. The aim of this study is to evaluate the safety and efficacy of ADSTEM Inj. against Placebo in the treatment of atopic dermatitis in patients with moderate to severe acute and chronic atopic.

Official title: A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

Key Details

Gender

All

Age Range

19 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2019-12-11

Completion Date

2027-10-31

Last Updated

2024-03-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

ADSTEM Inj.

Two 5mL of the following study drug is pre-mixed with 320mL of 0.9% normal saline is injected intravenously twice for the duration of the study. Treatment group: ADSTEM Inj. 0.5x10\^8 cells/5mL

OTHER

Placebo

330mL of 0.9% normal saline is injected intravenously twice for the duration of the study.

Locations (6)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, South Korea

Korea University AnSan Hospital

Ansan, Gyeonggi-do, South Korea

Chung-Ang University Hospital

Seoul, Seoulteukbyeolsi, South Korea

Kyunghee University Medical Center

Seoul, Seoulteukbyeolsi, South Korea

Seoul National University Hospital

Seoul, Seoulteukbyeolsi, South Korea

SMG-SNU Boramae Medical Center

Seoul, Seoulteukbyeolsi, South Korea