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Completed

NCT Number: NCT03269773

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Eczema Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pusan National University Hospital, Busan, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Placebo

Other

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)

Primary outcomes

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

    Time frame: 12 week

Secondary outcomes

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

    Time frame: 12 week

  2. Change and rafe of change in EASI index

    Time frame: 24weeks

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

    Time frame: 24weeks

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

    Time frame: 24weeks

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

    Time frame: 24weeks

  6. Change and rafe of change in SCORAD index

    Time frame: 24weeks

  7. Change and rafe of change in Body Surface Area (BSA)

    Time frame: 24weeks

  8. Change in total serum Immunoglobulin E (IgE)

    Time frame: 24weeks

  9. Change in Cytokine (TNF-a, Interleukin (IL)-4, IL-5, IL-6, IL-8, IL-13, IL-31, TARC (CCL17) and CCL 27 analysis)

    Time frame: 24weeks

  10. Total number of use and consumed amount of rescue medicine

    Time frame: 24weeks

Sponsors and collaborators

Lead sponsor

Kang Stem Biotech Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 1, 2017
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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