- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04137562
Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
A Multicenter, Randomized, Single-Blind, Phase Ⅱ Clinical Trial and Open Label Long-term Observation Study of ADSTEM Inj. to Evaluate the Safety and Efficacy in Patients with Moderate to Severe Subacute and Chronic Atopic Dermatitis.
The aim of this study is to evaluate the safety and efficacy of ADSTEM Inj. against Placebo in the treatment of atopic dermatitis in patients with moderate to severe acute and chronic atopic.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Chungcheongnam-do
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Daejeon, Chungcheongnam-do, Korea, Republic of
- Chungnam National University Hospital
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Gyeonggi-do
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Ansan, Gyeonggi-do, Korea, Republic of
- Korea University Ansan Hospital
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Seoulteukbyeolsi
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Seoul, Seoulteukbyeolsi, Korea, Republic of
- Chung-Ang University Hospital
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Seoul, Seoulteukbyeolsi, Korea, Republic of
- Kyunghee University Medical Center
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Seoul, Seoulteukbyeolsi, Korea, Republic of
- Seoul National University Hospital
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Seoul, Seoulteukbyeolsi, Korea, Republic of
- SMG-SNU Boramae Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- At the time of visit 1, only men and women aged between 19 and 70
- Patients with atopic dermatitis meeting the Hanifin and Rajka diagnostic criteria
- Subacute and chronic patients with symptoms of atopic dermatitis lasting at least 6 months
Patients with moderate to severe atopic dermatitis who meet all of the following criteria
- SCORAD score ≥ 20points
- EASI score ≥ 12points
- BSA ≥ 10%
- Patients with inadequate response to the stable use of topical atopic dermatitis treatment within 24 weeks prior to study initiation, or those who are unable to administer topical atopic dermatitis treatment due to safety reasons
- Patients who voluntarily agreed in writing to participate in this clinical trial
Exclusion Criteria:
- Patients with systemic infection symptoms at the time of clinical trials
- Patients with HIV, HBV, HCV, Syphilis test positive
- Patients with uncontrolled asthma disease at the time of clinical trial participation
- Patients who were considered inevitable to receive the medication from 1 month prior to administration of the clinical trial drug to visit 6 such as Immune function modifier(tacrolimus, pimecrolimus, cyclosporine, etc.), and high-frequency topical steroids in Groups 1 to 5, systemic steroids, systemic photochemotherapy, medication that are thought to affect other immune functions (such as immunoglobulin therapy like dupilumab, tralloquinap and desensitization therapy, etc.)
- Women who are pregnant, breastfeeding or have a pregnancy plan up to visit 6 or who do not use available contraceptive methods (women of childbearing age must be negative in screening pregnancy test)
- If patients are the male subject, Those who do not agree to have a contraception during the clinical trial (If the male subject or female partner is infertile, the above-mentioned contravention method is unnecessary)
- Patients participating in other clinical trials or participating in other clinical trials within the last 30 days
- Patients who have experienced significant adverse events during treatment with stem cell therapies
- Patients with stem cell therapy doses or history of participating in clinical trials
- Patients with a history of hypersensitivity to antibiotics and antifungal agents used in the manufacture of medicines for clinical trials
- Patients with renal dysfunction whose creatinine level is more than twice the normal upper limit in the screening test
- Patients with hepatic dysfunction whose AST (Aspartate Amino Transaminase) and ALT (Alanine Amino Transaminase) levels are more than three times the normal upper limit
- Patients who are not suitable for this clinical trial under the judgment of the other examiners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADSTEM Inj.
ADSTEM Inj.
hAD-MSC 1.0x10^8 cells
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Two 5mL of the following study drug is pre-mixed with 320mL of 0.9% normal saline is injected intravenously twice for the duration of the study.
Treatment group: ADSTEM Inj.
0.5x10^8 cells/5mL
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Placebo Comparator: Placebo
0.9% Normal Saline Inj.
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330mL of 0.9% normal saline is injected intravenously twice for the duration of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EASI-50
Time Frame: 16 weeks
|
Percentage of subjects whose EASI score decreased by 50% or more at 16 weeks compared to baseline
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EASI-50
Time Frame: 4, 8, 12 weeks
|
Percentage of subjects whose EASI score decreased by 50% or more at 4, 8 and 12 weeks compared to baseline
|
4, 8, 12 weeks
|
EASI-75
Time Frame: 4, 8, 12, 16 weeks
|
Percentage of subjects whose EASI score decreased by 75% or more at 4, 8, 12 and 16 weeks compared to baseline
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4, 8, 12, 16 weeks
|
EASI score
Time Frame: 4, 8, 12, 16 weeks
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EASI score change at 4, 8, 12 and 16 weeks compared to baseline
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4, 8, 12, 16 weeks
|
SCORAD-50
Time Frame: 4, 8, 12, 16 weeks
|
Percentage of subjects whose SCORAD score decreased by 50% or more at 4, 8, 12 and 16 weeks compared to baseline
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4, 8, 12, 16 weeks
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SCORAD-75
Time Frame: 4, 8, 12, 16 weeks
|
Percentage of subjects whose SCORAD score decreased 75% or more at 4, 8, 12 and 16 weeks compared to baseline
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4, 8, 12, 16 weeks
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SCORAD score
Time Frame: 4, 8, 12, 16 weeks
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SCORAD score change at 4, 8, 12 and 16 weeks compared to baseline
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4, 8, 12, 16 weeks
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SCORAD subgroup
Time Frame: 4, 8, 12, 16 weeks
|
SCORAD evaluation items(Extent Criteria, erythema, edema/population, oozing/crusting, excoriation, lichenification, dryness, pruritus, insomnia) score change at 4, 8, 12 and 16 weeks compared to baseline
|
4, 8, 12, 16 weeks
|
Severity
Time Frame: 4, 8, 12, 16 weeks
|
Severity change of disease at 4, 8, 12 and 16 weeks compared to baseline
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4, 8, 12, 16 weeks
|
IGA grade
Time Frame: 4, 8, 12, 16 weeks
|
Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline
|
4, 8, 12, 16 weeks
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IGA -1 or more grade
Time Frame: 4, 8, 12, 16 weeks
|
Percentage of subjects who dropped one or more grades on the Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline
|
4, 8, 12, 16 weeks
|
IGA -2 or more grade
Time Frame: 4, 8, 12, 16 weeks
|
Percentage of subjects who dropped two or more grades on the Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline
|
4, 8, 12, 16 weeks
|
Total IgE
Time Frame: 4, 8, 12, 16 weeks
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Total IgE change at 4, 8, 12, 16 weeks compared to baseline
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4, 8, 12, 16 weeks
|
PGE2 and ECP
Time Frame: 4, 8, 12, 16 weeks
|
Prostaglandin E2 (PGE2) and Eosinophil Cationic Protein (ECP) changes at 4, 8, 12 and 16 weeks compared to baseline
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4, 8, 12, 16 weeks
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Immune cytokine
Time Frame: 4, 8, 12, 16 weeks
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TGF-1, interleukin (IL)-4, 5, 6, 8, 13, 31 and CCL17 at 4, 8, 12 and 16 weeks compared to baseline
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4, 8, 12, 16 weeks
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Remedy used days and frequency
Time Frame: 4, 8, 12, 16 weeks
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Days and frequency of used remedies at 4, 8, 12 and 16 weeks
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4, 8, 12, 16 weeks
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Remedy used subjects
Time Frame: 4, 8, 12, 16 weeks
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Percentage of subjects whom used remedies at 4, 8,12 and 16 weeks
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4, 8, 12, 16 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Seongjun Seo, M.D, Ph.D, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
- Principal Investigator: Sanguk Son, M.D, Ph.D, Korea University Ansan Hospital
- Principal Investigator: Soyeon Jo, M.D, Ph.D, SMG-SNU Boramae Medical Center
- Principal Investigator: Young-joon Seo, M.D, Ph.D, Chungnam National University Hospital
- Principal Investigator: Donghun Lee, M.D, Ph.D, Seoul National University Hospital
- Principal Investigator: Mingyeong Shin, M.D, Ph.D, Kyunghee University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AD-CP-18-1
- 30902 (Other Grant/Funding Number: Republic of Korea Ministry of Food and Durg Safety)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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