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Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04725136
Recruitment Status : Recruiting
First Posted : January 26, 2021
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Kang Stem Biotech Co., Ltd.

Brief Summary:
A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD inj. for Moderate to Severe Chronic Atopic Dermatitis

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: FURESTEM-AD inj Phase 1 Phase 2

Detailed Description:

Phase 1: Multicenter, repeated administration, disclosure, dose escalation, Evaluate safety and tolerability and explore efficacy

Phase 2a: Multicenter, repeated administration, random assignment, double blinding, parallel, Efficacy and safety are evaluated for repeated administration compared to placebo and single administration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I/IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
Actual Study Start Date : January 27, 2021
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Safety

Arm Intervention/treatment
Experimental: High-dose repeat administration group
FURESTEM-AD Inj 1.0 x 10^8 cells /body 3 repeated subcutaneous injection at 4 week intervals
Biological: FURESTEM-AD inj
Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.

Experimental: High-dose single administration group
FURESTEM-AD Inj 1.0 x 10^8 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals
Biological: FURESTEM-AD inj
Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.

Experimental: Low-dose repeat administration group
FURESTEM-AD Inj 5.0 x 10^7 cells /body 3 repeated subcutaneous injection at 4 week intervals
Biological: FURESTEM-AD inj
Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.

Experimental: Low-dose single administration group
FURESTEM-AD Inj 5.0 x 10^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals
Biological: FURESTEM-AD inj
Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.

Placebo Comparator: Placebo
Normal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals
Biological: FURESTEM-AD inj
Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.




Primary Outcome Measures :
  1. Safety Assessment [ Time Frame: 24 weeks follow-up after first treatment ]
    safety information including drug tolerability


Secondary Outcome Measures :
  1. Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50) [ Time Frame: 24 weeks follow-up after first treatment ]
  2. Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75) [ Time Frame: 24 weeks follow-up after first treatment ]
  3. Rate of change and Change in EASI from baseline [ Time Frame: 24 weeks follow-up after first treatment ]
    EASI range is from 0 (clear) to 72 (severe)

  4. Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1 [ Time Frame: 24 weeks follow-up after first treatment ]
    IGA score is from 0 (clear) to 5 (severe)

  5. Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher [ Time Frame: 24 weeks follow-up after first treatment ]
    IGA score is from 0 (clear) to 5 (severe)

  6. Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50) [ Time Frame: 24 weeks follow-up after first treatment ]
  7. Rate of change and Change in SCORAD index from baseline at each visit [ Time Frame: 24 weeks follow-up after first treatment ]
    SCORAD index range is from 0 (clear) to 103 (severe)

  8. Change and rate of change in Body Surface Area (BSA) [ Time Frame: 24 weeks follow-up after first treatment ]
  9. Change and rate of change in total serum Immunoglobulin E (IgE) [ Time Frame: 24 weeks follow-up after first treatment ]
  10. Change and rate of change in Cytokine [ Time Frame: 24 weeks follow-up after first treatment ]
    CCL17(TARC), CCL18(PARC), CCL26(eotaxin-3), CCL27(CTACK), IL-4, IL-17A, IL-22, SCCA2

  11. Change and rate of change DLQI [ Time Frame: 24 weeks follow-up after first treatment ]
  12. Change and rate of change POEM [ Time Frame: 24 weeks follow-up after first treatment ]
  13. Change and rate of change Peak Pruritus NRS [ Time Frame: 24 weeks follow-up after first treatment ]
  14. Change and rate of change eosinophil [ Time Frame: 24 weeks follow-up after first treatment ]
  15. Use the number and total amount of rescue [ Time Frame: 24 weeks follow-up after first treatment ]
    only Phase 2a



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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>=16 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. Renal dysfunction with creatinine >2.0 mg/dL at screening
  4. Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening
  5. ALC<800/mm3 at screening
  6. Subjects with live vaccine administration within 12 weeks before baseline
  7. Receipt of leukotriene receptor antagonists, systemic steroids, systemic or topical antihistamines, phototherapy, or systemic immunosuppressants/modulators including janus kinase (JAK) inhibitors, and/or any other systemic therapy within 4 weeks before Baseline
  8. Receipt of topical steroids(class1~6), topical tacrolimus or pimecrolimus within 2 weeks before Baseline
  9. Subjects who need prohibited medication during clinical period
  10. Pregnant, breast-feeding women or women who plan to become pregnant during this study
  11. Subjects who currently participate in other clinical trial or participated in other clinical trial within 4 weeks
  12. Subjects with experience of administering FURESTEM-AD inj.
  13. Any other condition which the investigator judges would make patient unsuitable for study participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725136


Contacts
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Contact: Eundeok Yeo 82-2-888-1592 edyeo@kangstem.com
Contact: Seulbi Lee 82-2-888-1592 sblee@kangstem.com

Locations
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Korea, Republic of
Dongguk University Medical Center Completed
Ilsan, Korea, Republic of
Seoul National Hospital Recruiting
Seoul, Korea, Republic of
Contact: Donghoon Lee, Professor         
Sponsors and Collaborators
Kang Stem Biotech Co., Ltd.
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Responsible Party: Kang Stem Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04725136    
Other Study ID Numbers: K0104
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kang Stem Biotech Co., Ltd.:
hUCB-MSC
Atopic Dermatitis
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases