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

Atopic Dermatitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

This clinical trial is designed with multi-organization, random assignment, single-blind, second-phase clinical trials and open long-term follow up studies, and is intended for patients with secondary or above subacuteal and chronic atopic dermatitis. If the test subjects voluntarily agree in writing to participate in this clinical trial, they shall conduct the examination and examination required for four weeks prior to administration of the investigational product (visit 1) in accordance with the clinical trial plan. As a result of the suitability assessment of the test subjects, those who comply with the inclusion/exclusion criteria, adipose tissue will be collected through the liposuction method and randomly assigned to each arms. Subjects who are eligible for administration of the investigational product on the day of administration (visit 2) under the investigator's judgment are given intravenous administration of the clinical trial medication once at the date of administration (visit 2, visit 3) and follow-up inspection is conducted at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the first administration of the investigational product and safety and efficacy assessments are conducted for a total of 16 weeks. The test subjects assigned to the placebo group shall be compensated by administering a experimental drug on demand after the visit 6. It is a principle to administer the test drug prepared from the previously obtained adipose tissue, and it is possible to carry out further adipose tissue collection if necessary. However, no safety and efficacy assessments of compensatory treatments will be collected. Safety and efficacy will be analyzed after all the subjects has completed visit 6. For the experimental group only, long-term observation study for safety assessment is conducted at the point of 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months after the second administration of the investigational product for a total of 5 years. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04137562
Study type Interventional
Source EHL Bio Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 2
Start date December 11, 2019
Completion date October 31, 2027
View Details
See also
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