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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

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:

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

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

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

NCT ID

NCT04725136

First Posted

January 25, 2021

Last Updated

January 10, 2022

Sponsor

Kang Stem Biotech Co., Ltd.

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

Studies a U.S. FDA-regulated Device Product

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