Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)

Atopic Dermatitis Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03269773
• Other study ID #: K0102
• Status: Completed
• Phase: Phase 3
• Start date: April 25, 2018
• Est. completion date: June 20, 2019

Study information

• Verified date: September 2019
• Source: Kang Stem Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: June 20, 2019
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Of either gender, aged >=19

2. Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria

3. Chronic Atopic Dermatitis that has been present for at least 3 years

4. EASI>=12 at screening and baseline visit

5. IGA>=3, SCORAD index>=25, BSA >=10% of AD involvement at screegning and baseline visit

6. Subjects with documented record of inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks before participating in the study, or whom are inadvisable due to safety risks

7. Subjects who understand and voluntarily sign an informed consent form

Exclusion Criteria:

1. Subjects with medical history or surgery/procedure history

2. Subjects with diseases at the time of participation in this study (systemic infection, other serious skin disorders, pigmentation or extensive scarring in atopic dermatitis symptom region)

3. Subjects who need prohibited medication during clinical period

4. Pregnant, breast-feeding women or women who plan to become pregnant during this study

5. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks

6. Any other condition which the investigator judges would make patient unsuitable for study participation

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Biological:
• FURESTEM-AD Inj.
0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL). Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL

Other:
• Placebo
0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Dongguk University Medical Center	Ilsan
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Catholic Medical Center	Seoul
Korea, Republic of	Chung-Ang University Healthcare System	Seoul
Korea, Republic of	Hanyang University Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Kang Stem Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)		12 week
Secondary	over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)		12 week
Secondary	Change and rafe of change in EASI index		24weeks
Secondary	Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1		24weeks
Secondary	Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points		24weeks
Secondary	over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)		24weeks
Secondary	Change and rafe of change in SCORAD index		24weeks
Secondary	Change and rafe of change in Body Surface Area (BSA)		24weeks
Secondary	Change in total serum Immunoglobulin E (IgE)		24weeks
Secondary	Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)		24weeks
Secondary	Total number of use and consumed amount of rescue medicine		24weeks