search
Back to results

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

Primary Purpose

Atopic Dermatitis

Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
FURESTEM-AD inj
Sponsored by
Kang Stem Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring hUCB-MSC, Atopic Dermatitis

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dongguk University Medical Center
  • Seoul National HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

High-dose repeat administration group

High-dose single administration group

Low-dose repeat administration group

Low-dose single administration group

Placebo

Arm Description

FURESTEM-AD Inj 1.0 x 10^8 cells /body 3 repeated subcutaneous injection at 4 week intervals

FURESTEM-AD Inj 1.0 x 10^8 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals

FURESTEM-AD Inj 5.0 x 10^7 cells /body 3 repeated subcutaneous injection at 4 week intervals

FURESTEM-AD Inj 5.0 x 10^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals

Normal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals

Outcomes

Primary Outcome Measures

Safety Assessment
safety information including drug tolerability

Secondary Outcome Measures

Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)
Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)
Rate of change and Change in EASI from baseline
EASI range is from 0 (clear) to 72 (severe)
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
IGA score is from 0 (clear) to 5 (severe)
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
IGA score is from 0 (clear) to 5 (severe)
Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)
Rate of change and Change in SCORAD index from baseline at each visit
SCORAD index range is from 0 (clear) to 103 (severe)
Change and rate of change in Body Surface Area (BSA)
Change and rate of change in total serum Immunoglobulin E (IgE)
Change and rate of change in Cytokine
CCL17(TARC), CCL18(PARC), CCL26(eotaxin-3), CCL27(CTACK), IL-4, IL-17A, IL-22, SCCA2
Change and rate of change DLQI
Change and rate of change POEM
Change and rate of change Peak Pruritus NRS
Change and rate of change eosinophil
Use the number and total amount of rescue
only Phase 2a

Full Information

First Posted
January 25, 2021
Last Updated
January 10, 2022
Sponsor
Kang Stem Biotech Co., Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT04725136
Brief Title
Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2021 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kang Stem Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
hUCB-MSC, Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-dose repeat administration group
Arm Type
Experimental
Arm Description
FURESTEM-AD Inj 1.0 x 10^8 cells /body 3 repeated subcutaneous injection at 4 week intervals
Arm Title
High-dose single administration group
Arm Type
Experimental
Arm Description
FURESTEM-AD Inj 1.0 x 10^8 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals
Arm Title
Low-dose repeat administration group
Arm Type
Experimental
Arm Description
FURESTEM-AD Inj 5.0 x 10^7 cells /body 3 repeated subcutaneous injection at 4 week intervals
Arm Title
Low-dose single administration group
Arm Type
Experimental
Arm Description
FURESTEM-AD Inj 5.0 x 10^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals
Intervention Type
Biological
Intervention Name(s)
FURESTEM-AD inj
Intervention Description
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 Measure Information:
Title
Safety Assessment
Description
safety information including drug tolerability
Time Frame
24 weeks follow-up after first treatment
Secondary Outcome Measure Information:
Title
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
Title
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
Title
Rate of change and Change in EASI from baseline
Description
EASI range is from 0 (clear) to 72 (severe)
Time Frame
24 weeks follow-up after first treatment
Title
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
Description
IGA score is from 0 (clear) to 5 (severe)
Time Frame
24 weeks follow-up after first treatment
Title
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
Description
IGA score is from 0 (clear) to 5 (severe)
Time Frame
24 weeks follow-up after first treatment
Title
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
Title
Rate of change and Change in SCORAD index from baseline at each visit
Description
SCORAD index range is from 0 (clear) to 103 (severe)
Time Frame
24 weeks follow-up after first treatment
Title
Change and rate of change in Body Surface Area (BSA)
Time Frame
24 weeks follow-up after first treatment
Title
Change and rate of change in total serum Immunoglobulin E (IgE)
Time Frame
24 weeks follow-up after first treatment
Title
Change and rate of change in Cytokine
Description
CCL17(TARC), CCL18(PARC), CCL26(eotaxin-3), CCL27(CTACK), IL-4, IL-17A, IL-22, SCCA2
Time Frame
24 weeks follow-up after first treatment
Title
Change and rate of change DLQI
Time Frame
24 weeks follow-up after first treatment
Title
Change and rate of change POEM
Time Frame
24 weeks follow-up after first treatment
Title
Change and rate of change Peak Pruritus NRS
Time Frame
24 weeks follow-up after first treatment
Title
Change and rate of change eosinophil
Time Frame
24 weeks follow-up after first treatment
Title
Use the number and total amount of rescue
Description
only Phase 2a
Time Frame
24 weeks follow-up after first treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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>=16 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) Renal dysfunction with creatinine >2.0 mg/dL at screening Hepatic dysfunction with ALT or AST levels 2.5 times higher than the normal range at screening ALC<800/mm3 at screening Subjects with live vaccine administration within 12 weeks before baseline 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 Receipt of topical steroids(class1~6), topical tacrolimus or pimecrolimus within 2 weeks before Baseline 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 Subjects with experience of administering FURESTEM-AD inj. Any other condition which the investigator judges would make patient unsuitable for study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eundeok Yeo
Phone
82-2-888-1592
Email
edyeo@kangstem.com
First Name & Middle Initial & Last Name or Official Title & Degree
Seulbi Lee
Phone
82-2-888-1592
Email
sblee@kangstem.com
Facility Information:
Facility Name
Dongguk University Medical Center
City
Ilsan
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Seoul National Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donghoon Lee, Professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs