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

NCT04137562 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2024-03-15

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • EHL Bio Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Seongjun Seo, M.D, Ph.D · Chung-Ang University Hosptial, Chung-Ang University College of Medicine

  • Sanguk Son, M.D, Ph.D · Korea University Ansan Hospital

  • Soyeon Jo, M.D, Ph.D · SMG-SNU Boramae Medical Center

  • Young-joon Seo, M.D, Ph.D · Chungnam National University Hospital

  • Donghun Lee, M.D, Ph.D · Seoul National University Hospital

  • Mingyeong Shin, M.D, Ph.D · Kyunghee University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2023-01-26
Completion
2027-10-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04137562 on ClinicalTrials.gov