Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj. for Moderate to Severe Chronic Atopic Dermatitis
NCT ID: NCT04725136
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
96 participants
INTERVENTIONAL
2021-01-27
2023-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderate to Severe Chronic Atopic Dermatitis(AD)
NCT03269773
Long-term Follow-up Study to Evaluate the Safety and Explore the Efficacy of Multiple Doses of FURESTEM-AD Inj
NCT04730024
Safety and Efficacy of FURESTEM-AD Inj. for Moderate to Severe Atopic Dermatitis (AD)
NCT05004324
Evalution the Safety and Efficacy in Atopic Dermatitis Patients
NCT03962387
Safety and Efficacy of FURESTEM-AD Inj. in Patients With Moderately Subacute and Chronic Atopic Dermatitis (AD)
NCT01927705
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Phase 2a: Multicenter, repeated administration, random assignment, double blinding, parallel, Efficacy and safety are evaluated for repeated administration compared to placebo and single administration.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
High-dose repeat administration group
FURESTEM-AD Inj 1.0 x 10\^8 cells /body 3 repeated subcutaneous injection at 4 week intervals
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.
High-dose single administration group
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
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.
Low-dose repeat administration group
FURESTEM-AD Inj 5.0 x 10\^7 cells /body 3 repeated subcutaneous injection at 4 week intervals
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.
Low-dose single administration group
FURESTEM-AD Inj 5.0 x 10\^7 cells /body 1 single subcutaneous injection, and Placebo 2 repeated subcutaneous injection at 4 week intervals
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.
Placebo
Normal saline(0.9% NaCl) 3 repeated subcutaneous injection at 4 week intervals
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
19 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kang Stem Biotech Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dongguk University Medical Center
Ilsan, , South Korea
Seoul National Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Donghoon Lee, Professor
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
K0104
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.