NCT03962387

Brief Summary

A multi-center, open, long-term follow-up study to evaluate the efficacy and safety of FURESTEM-AD inj. in patients with moderate to severe chronic atopic dermatitis: 5-year results from the K0102 extension study

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
98

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 28, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

April 5, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

4.7 years

First QC Date

November 28, 2018

Last Update Submit

June 15, 2021

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Safety Assessment (Rate of Adverse Event, Number of Participants with Adverse Event)

    5 years

Secondary Outcomes (12)

  • Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 50% at Week 12 (EASI-50)

    3 years

  • Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at Week 12 (EASI-75)

    3 years

  • Rate of change in EASI from baseline

    3 years

  • Change in EASI from baseline

    3 years

  • Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1

    3 years

  • +7 more secondary outcomes

Study Arms (1)

Atopic Dermatitis

Other: Not applicable(observational study)

Interventions

Not applicable(observational study)OTHER

Not applicable(observational study)

Atopic Dermatitis

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

moderate to severe chronic atopic dermatitis

You may qualify if:

  • Subject who enrolled K0102 Clinical Trial(parent study).
  • Subjects who understand and voluntarily sign an informed consent form

You may not qualify if:

  • In case follow-up is not possible from end of K0102 clinical trial to end of this study period
  • 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 (1)

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2018

First Posted

May 24, 2019

Study Start

April 5, 2019

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

June 16, 2021

Record last verified: 2021-06

Locations

KR(1)