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Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

Primary Purpose

Atopic Dermatitis

Status
Active
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ADSTEM Inj.
Placebo
Sponsored by
EHL Bio Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Adipose Derived Mesenchymal Stem cell, ADMSC, AD, Inflammatory disease, ADMC, Stem cell, ehlbio

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    1. SCORAD score ≥ 20points
    2. EASI score ≥ 12points
    3. 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

Sites / Locations

  • Chungnam National University Hospital
  • Korea University AnSan Hospital
  • Chung-Ang University Hospital
  • Kyunghee University Medical Center
  • Seoul National University Hospital
  • SMG-SNU Boramae Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ADSTEM Inj.

Placebo

Arm Description

ADSTEM Inj. hAD-MSC 1.0x10^8 cells

0.9% Normal Saline Inj.

Outcomes

Primary Outcome Measures

EASI-50
Percentage of subjects whose EASI score decreased by 50% or more at 16 weeks compared to baseline

Secondary Outcome Measures

EASI-50
Percentage of subjects whose EASI score decreased by 50% or more at 4, 8 and 12 weeks compared to baseline
EASI-75
Percentage of subjects whose EASI score decreased by 75% or more at 4, 8, 12 and 16 weeks compared to baseline
EASI score
EASI score change at 4, 8, 12 and 16 weeks compared to baseline
SCORAD-50
Percentage of subjects whose SCORAD score decreased by 50% or more at 4, 8, 12 and 16 weeks compared to baseline
SCORAD-75
Percentage of subjects whose SCORAD score decreased 75% or more at 4, 8, 12 and 16 weeks compared to baseline
SCORAD score
SCORAD score change at 4, 8, 12 and 16 weeks compared to baseline
SCORAD subgroup
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
Severity
Severity change of disease at 4, 8, 12 and 16 weeks compared to baseline
IGA grade
Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline
IGA -1 or more grade
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
IGA -2 or more grade
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
Total IgE
Total IgE change at 4, 8, 12, 16 weeks compared to baseline
PGE2 and ECP
Prostaglandin E2 (PGE2) and Eosinophil Cationic Protein (ECP) changes at 4, 8, 12 and 16 weeks compared to baseline
Immune cytokine
TGF-1, interleukin (IL)-4, 5, 6, 8, 13, 31 and CCL17 at 4, 8, 12 and 16 weeks compared to baseline
Remedy used days and frequency
Days and frequency of used remedies at 4, 8, 12 and 16 weeks
Remedy used subjects
Percentage of subjects whom used remedies at 4, 8,12 and 16 weeks

Full Information

First Posted
October 21, 2019
Last Updated
February 14, 2023
Sponsor
EHL Bio Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04137562
Brief Title
Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 11, 2019 (Actual)
Primary Completion Date
January 26, 2023 (Actual)
Study Completion Date
May 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EHL Bio Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
This clinical trial is designed with multi-organization, random assignment, single-blind, second-phase clinical trials and open long-term follow up studies, and is intended for patients with secondary or above subacuteal and chronic atopic dermatitis. If the test subjects voluntarily agree in writing to participate in this clinical trial, they shall conduct the examination and examination required for four weeks prior to administration of the investigational product (visit 1) in accordance with the clinical trial plan. As a result of the suitability assessment of the test subjects, those who comply with the inclusion/exclusion criteria, adipose tissue will be collected through the liposuction method and randomly assigned to each arms. Subjects who are eligible for administration of the investigational product on the day of administration (visit 2) under the investigator's judgment are given intravenous administration of the clinical trial medication once at the date of administration (visit 2, visit 3) and follow-up inspection is conducted at 4 weeks, 8 weeks, 12 weeks, and 16 weeks after the first administration of the investigational product and safety and efficacy assessments are conducted for a total of 16 weeks. The test subjects assigned to the placebo group shall be compensated by administering a experimental drug on demand after the visit 6. It is a principle to administer the test drug prepared from the previously obtained adipose tissue, and it is possible to carry out further adipose tissue collection if necessary. However, no safety and efficacy assessments of compensatory treatments will be collected. Safety and efficacy will be analyzed after all the subjects has completed visit 6. For the experimental group only, long-term observation study for safety assessment is conducted at the point of 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months after the second administration of the investigational product for a total of 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Adipose Derived Mesenchymal Stem cell, ADMSC, AD, Inflammatory disease, ADMC, Stem cell, ehlbio

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Participants and efficacy outcome assessor will be blinded
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADSTEM Inj.
Arm Type
Experimental
Arm Description
ADSTEM Inj. hAD-MSC 1.0x10^8 cells
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
0.9% Normal Saline Inj.
Intervention Type
Biological
Intervention Name(s)
ADSTEM Inj.
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
330mL of 0.9% normal saline is injected intravenously twice for the duration of the study.
Primary Outcome Measure Information:
Title
EASI-50
Description
Percentage of subjects whose EASI score decreased by 50% or more at 16 weeks compared to baseline
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
EASI-50
Description
Percentage of subjects whose EASI score decreased by 50% or more at 4, 8 and 12 weeks compared to baseline
Time Frame
4, 8, 12 weeks
Title
EASI-75
Description
Percentage of subjects whose EASI score decreased by 75% or more at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
EASI score
Description
EASI score change at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
SCORAD-50
Description
Percentage of subjects whose SCORAD score decreased by 50% or more at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
SCORAD-75
Description
Percentage of subjects whose SCORAD score decreased 75% or more at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
SCORAD score
Description
SCORAD score change at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
SCORAD subgroup
Description
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
Time Frame
4, 8, 12, 16 weeks
Title
Severity
Description
Severity change of disease at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
IGA grade
Description
Investigator's Global Assessment (IGA) score at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
IGA -1 or more grade
Description
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
Time Frame
4, 8, 12, 16 weeks
Title
IGA -2 or more grade
Description
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
Time Frame
4, 8, 12, 16 weeks
Title
Total IgE
Description
Total IgE change at 4, 8, 12, 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
PGE2 and ECP
Description
Prostaglandin E2 (PGE2) and Eosinophil Cationic Protein (ECP) changes at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
Immune cytokine
Description
TGF-1, interleukin (IL)-4, 5, 6, 8, 13, 31 and CCL17 at 4, 8, 12 and 16 weeks compared to baseline
Time Frame
4, 8, 12, 16 weeks
Title
Remedy used days and frequency
Description
Days and frequency of used remedies at 4, 8, 12 and 16 weeks
Time Frame
4, 8, 12, 16 weeks
Title
Remedy used subjects
Description
Percentage of subjects whom used remedies at 4, 8,12 and 16 weeks
Time Frame
4, 8, 12, 16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seongjun Seo, M.D, Ph.D
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanguk Son, M.D, Ph.D
Organizational Affiliation
Korea University Ansan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soyeon Jo, M.D, Ph.D
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Young-joon Seo, M.D, Ph.D
Organizational Affiliation
Chungnam National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Donghun Lee, M.D, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mingyeong Shin, M.D, Ph.D
Organizational Affiliation
Kyunghee University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungnam National University Hospital
City
Daejeon
State/Province
Chungcheongnam-do
Country
Korea, Republic of
Facility Name
Korea University AnSan Hospital
City
Ansan
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
State/Province
Seoulteukbyeolsi
Country
Korea, Republic of
Facility Name
Kyunghee University Medical Center
City
Seoul
State/Province
Seoulteukbyeolsi
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
State/Province
Seoulteukbyeolsi
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
State/Province
Seoulteukbyeolsi
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy in Patients With Moderate to Severe Subacute and Chronic Atopic Dermatitis

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