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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725136
• Other study ID #: K0104
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 27, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: January 2022
• Source: Kang Stem Biotech Co., Ltd.
• Contact: Eundeok Yeo
• Phone: 82-2-888-1592
• Email: edyeo[@]kangstem.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: May 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Medical Center	Ilsan
Korea, Republic of	Seoul National Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kang Stem Biotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Assessment	safety information including drug tolerability	24 weeks follow-up after first treatment
Secondary	Percentage of subjects whose EASI decreased by 50% or more at each evaluation visit compared to the baseline (EASI-50)		24 weeks follow-up after first treatment
Secondary	Percentage of subjects whose Eczema Area and Severity Index (EASI) was decreased from baseline by more than 75% at each visit (EASI-75)		24 weeks follow-up after first treatment
Secondary	Rate of change and Change in EASI from baseline	EASI range is from 0 (clear) to 72 (severe)	24 weeks follow-up after first treatment
Secondary	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)	24 weeks follow-up after first treatment
Secondary	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)	24 weeks follow-up after first treatment
Secondary	Percentage of subjects whose SCORing Atopic Dermatitis (SCORAD) INDEX was decreased from baseline by more than 50% at each visit (SCORAD-50)		24 weeks follow-up after first treatment
Secondary	Rate of change and Change in SCORAD index from baseline at each visit	SCORAD index range is from 0 (clear) to 103 (severe)	24 weeks follow-up after first treatment
Secondary	Change and rate of change in Body Surface Area (BSA)		24 weeks follow-up after first treatment
Secondary	Change and rate of change in total serum Immunoglobulin E (IgE)		24 weeks follow-up after first treatment
Secondary	Change and rate of change in Cytokine	CCL17(TARC), CCL18(PARC), CCL26(eotaxin-3), CCL27(CTACK), IL-4, IL-17A, IL-22, SCCA2	24 weeks follow-up after first treatment
Secondary	Change and rate of change DLQI		24 weeks follow-up after first treatment
Secondary	Change and rate of change POEM		24 weeks follow-up after first treatment
Secondary	Change and rate of change Peak Pruritus NRS		24 weeks follow-up after first treatment
Secondary	Change and rate of change eosinophil		24 weeks follow-up after first treatment
Secondary	Use the number and total amount of rescue	only Phase 2a	24 weeks follow-up after first treatment