NCT03269773

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
197

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2016

Completed
11 months until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

April 25, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

11 months

First QC Date

October 5, 2016

Last Update Submit

September 10, 2019

Conditions

Atopic Dermatitis

Keywords

Atopic DermatitisStem cellCell therapyskin diseaseUmbilical cord BloodUCB-MSChUCB-MSCADfurestemdermatitiseczema

Outcome Measures

Primary Outcomes (1)

  • over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)

    12 week

Secondary Outcomes (10)

  • over 75% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-75)

    12 week

  • Change and rafe of change in EASI index

    24weeks

  • Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1

    24weeks

  • Proportion of patients who Investigator's Global Assessment (IGA) score 0 or 1, or reduced more than 2 points

    24weeks

  • over 50% reduction ratio of SCORing Atopic Dermatitis (SCORAD) INDEX as contrasted with baseline value (SCORAD-50)

    24weeks

  • +5 more secondary outcomes

Study Arms (2)

FURESTEM-AD Inj.

EXPERIMENTAL

hUCB-MSC 5.0x10\^7 cells

Biological: FURESTEM-AD Inj.

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

FURESTEM-AD Inj.BIOLOGICAL

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

FURESTEM-AD Inj.
PlaceboOTHER

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)

Placebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Of either gender, aged \>=19
  • Atopic Dermatitis subjects who are coincident with Hanifin and Rajka diagnosis criteria
  • Chronic Atopic Dermatitis that has been present for at least 3 years
  • EASI\>=12 at screening and baseline visit
  • IGA\>=3, SCORAD index\>=25, BSA \>=10% of AD involvement at screegning and baseline visit
  • 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
  • Subjects who understand and voluntarily sign an informed consent form

You may not qualify if:

  • Subjects with medical history or surgery/procedure history
  • 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)
  • Subjects who need prohibited medication during clinical period
  • Pregnant, breast-feeding women or women who plan to become pregnant during this study
  • Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
  • Any other condition which the investigator judges would make patient unsuitable for study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Pusan National University Hospital

Busan, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Dongguk University Medical Center

Ilsan, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Catholic Medical Center

Seoul, 137-701, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Chung-Ang University Healthcare System

Seoul, South Korea

Location

Hanyang University Medical Center

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Dermatitis, AtopicSkin DiseasesDermatitisEczema

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2016

First Posted

September 1, 2017

Study Start

April 25, 2018

Primary Completion

March 30, 2019

Study Completion

June 20, 2019

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations

KR(11)