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

Kangstem Biotech

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Atopic Dermatitis

Treatments: Biological: FURESTEM-AD inj

Study type: Interventional

Funder types: Industry

Identifiers

NCT04725136

K0104

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 5 patient groups, including a placebo group

High-dose repeat administration group

Experimental group

Description:

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

Treatment:

Biological: FURESTEM-AD inj

High-dose single administration group

Experimental group

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

Treatment:

Biological: FURESTEM-AD inj

Low-dose repeat administration group

Experimental group

Description:

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

Treatment:

Biological: FURESTEM-AD inj

Low-dose single administration group

Experimental group

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

Treatment:

Biological: FURESTEM-AD inj

Placebo

Placebo Comparator group

Description:

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

Treatment:

Biological: FURESTEM-AD inj