Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
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
1 other identifier
interventional
96
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2021
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2021
CompletedFirst Posted
Study publicly available on registry
January 26, 2021
CompletedStudy Start
First participant enrolled
January 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedJanuary 11, 2022
January 1, 2022
2 years
January 25, 2021
January 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety Assessment
safety information including drug tolerability
24 weeks follow-up after first treatment
Secondary Outcomes (15)
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
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
Rate of change and Change in EASI from baseline
24 weeks follow-up after first treatment
Percentage of subjects whose Investigator's Global Assessment (IGA) score at each visit is 0 or 1
24 weeks follow-up after first treatment
Percentage of subjects whose IGA at each visit is 0 or 1, or improved to 2 or higher
24 weeks follow-up after first treatment
- +10 more secondary outcomes
Study Arms (5)
High-dose repeat administration group
EXPERIMENTALFURESTEM-AD Inj 1.0 x 10\^8 cells /body 3 repeated subcutaneous injection at 4 week intervals
High-dose single administration group
EXPERIMENTALFURESTEM-AD Inj 1.0 x 10\^8 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals
Low-dose repeat administration group
EXPERIMENTALFURESTEM-AD Inj 5.0 x 10\^7 cells /body 3 repeated subcutaneous injection at 4 week intervals
Low-dose single administration group
EXPERIMENTALFURESTEM-AD Inj 5.0 x 10\^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals
Placebo
PLACEBO COMPARATORNormal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dongguk University Medical Center
Ilsan, South Korea
Seoul National Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2021
First Posted
January 26, 2021
Study Start
January 27, 2021
Primary Completion
January 31, 2023
Study Completion
May 31, 2023
Last Updated
January 11, 2022
Record last verified: 2022-01