- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04179760
Safety and Efficacy of SCM-AGH in Subjects With Moderate to Severe Atopic Dermatitis
A Randomized, Phase I/II Trial to Evaluate the Safety and Efficacy of SCM-AGH in Subjects With Moderate to Severe Atopic Dermatitis
This study consists of two phases (Phase I and Phase II). Phase II will be conducted sequentially after the safety of SCM-AGH is secured in Phase I.
Phase I: Multicenter in Korea, Randomized, Open-label, Parallel arm Phase II: Multicenter in Korea, Double-blind, Placebo-controlled, Parallel arm
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Phase I (Multicenter, Randomized, Open-label, Parallel arm Design) Twenty subjects with moderate to severe Atopic Dermatitis(AD) are planned to be enrolled from 6 sites in Korea and administered with SCM-AGH by intravenous (IV) infusion 3 times at two-week intervals and evaluated for safety during the safety evaluation period (12 weeks after first infusion).
Phase II (Multicenter, Double-blind, Placebo-controlled, Parallel arm) Phase II of the study is randomized, double-blind, placebo-controlled, parallel arm comparison study in adult subjects with moderate to severe AD. 72 subjects with moderate to severe AD are planned to be enrolled from 6 sites in Korea. Following up to a 4-week Screening period, subjects will be randomly assigned to one of the following treatment arms: SCM-AGH or placebo in the ratio of 1:1.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Howard Her
- Phone Number: +8200000000
- Email: hher@scmlifescience.com
Study Locations
-
-
-
Incheon, Korea, Republic of
- Inha University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects who are males or females aged >= 19 years
Subjects who are diagnosed with Atopic Dermatitis (AD) based on the Eichenfield revised criteria of Hannifin and Rajka that
- has been present for at least 1 year before the Screening visit, and
- have chronic AD symptoms continually for at least 6 months before Screening visit
- Subjects who have moderate to severe AD (EASI ≥16) at the Screening visit and Baseline visit
- Subjects who have IGA score ≥3 at the Screening and Baseline visits
- Subjects who have at least 10% of total body surface area affected by AD at the Screening and Baseline visits
- Subjects who can give written informed consent
- Subjects must have applied a stable dose of a bland emollient to affected areas for at least 7 days before the Baseline visit and be willing to continue for the duration of the study
- Male subjects must abstain from heterosexual activities or agree to use a condom through 30 days after the final dose of study drug. Women of childbearing potential (WOCBP) must abstain from heterosexual activities or agree to use effective contraception through 30 days after the final dose of study drug.
Effective contraception for males and/or WOCBP includes:
- Blockage methods - spermicides and condoms/spermicides and vaginal diaphragm for contraception, vaginal sponges or cervical cap (where available)
- Oral contraceptives ("the pill") for at least 1 month
- Depot or injectable birth control or implantable contraception (e.g., Implanon)
- Intrauterine device (IUD)
- Documented evidence of surgical sterilization at least 6 months prior to Screening visit i.e., tubal ligation or hysterectomy for women or vasectomy for men
- Women who are post-menopausal, as documented by measurement of follicle stimulating hormone
Exclusion Criteria:
- Systemic infection or local infection requiring prohibited medications at Screening visit
Subjects who underwent the following treatments within 4 weeks prior to Baseline visit or are scheduled to receive the following treatments within 4 weeks from Baseline at the discretion of investigator:
- Use of immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ (interferon-gamma), Janus kinase inhibitors, azathioprine, methotrexate)
- Phototherapy for AD
- Any other systemic therapy used to treat AD or symptoms of AD (approved or off-label use)
- Use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within at least 2 weeks prior to Baseline
- History of anaphylaxis to any biologic therapy or vaccine
- History of Guillain-Barré syndrome
- Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
- Any allergen immunotherapy within 4 months prior to or throughout the study
- A value outside the specified range of 90 mmHg - 140 mmHg for systolic blood pressure and 50 mmHg -90 mmHg for diastolic blood pressure (both inclusive) at Screening (can be repeated once at Screening as per Principal Investigator's [PI's] discretion).
- Receipt of live vaccines within 12 weeks prior to Baseline
Receipt of the following biologics:
- Cell depleting agents such as rituximab: within 6 months prior to Baseline or within time to return of lymphocyte count to normal, whichever is longer
- Other biologics: within 5 half-lives or within 16 weeks prior to Baseline, whichever is longer
- Active infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus (HCV)
- Female subjects who are pregnant or lactating or female subjects of childbearing potential who have a pregnancy plan or do not agree to use acceptable methods of contraception, excluding females who are in post-menopausal or surgically infertile (bilateral tubal ligation, bilateral oophorectomy or complete hysterectomy)
- Receipt of any investigational drugs within 8 weeks prior to baseline, within 5 half lives of investigational drug or participated in any clinical trials of medical device
- Diagnosed with either primary or recurrent malignancy within 5 years from Screening
- Liver malfunctions with aspartate aminotransferase (AST) / alanine aminotransferase (ALT) level >2x upper limit of normal (ULN) at Screening
- Renal malfunctions with creatinine level >2x ULN at Screening
- QTc (corrected QT interval) prolongation >470 msec or other significant ECG abnormality noted within 14 days of treatment
- History of hypersensitivity to antibiotics and antimicrobial agents
- History of significant Adverse Events (AEs) during stem cell therapies
- Allergic or hypersensitivity reaction to the IP (Investigational Product), drug of similar class or ingredients [bovine serum, dimethyl sulfoxide (DMSO)]
- Failure to comply with emollient application instructions prior to baseline, per diary
- Subjects who, in the opinion of the investigator, have other unstable intercurrent diseases that confound safety and efficacy assessment
- Planned or anticipated major surgical procedure during the subject's participation in this study
- Subjects who, in the opinion of the investigator, would be non-compliant with the visit schedule of study procedures
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
3 times with 2-week intervals by IV infusion.
|
Placebo will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4).
|
Experimental: SCM-AGH
|
SCM-AGH will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
Time Frame: Week 12
|
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index).
The minimum EASI score is 0 and the maximum EASI score is 72.
Higher scores mean worse outcome.
|
Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score change from Baseline in Eczema Area and Severity Index(EASI) score
Time Frame: Weeks 4, 8, 12, 16, 20 and 24
|
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index).
The minimum EASI score is 0 and the maximum EASI score is 72.
Higher scores mean worse outcome.
|
Weeks 4, 8, 12, 16, 20 and 24
|
Percentage of subjects who have EASI-75 (improvement of ≥75% in EASI score from Baseline)
Time Frame: Weeks 12, 16, 20 and 24
|
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index).
The minimum EASI score is 0 and the maximum EASI score is 72.
Higher scores mean worse outcome.
|
Weeks 12, 16, 20 and 24
|
Percentage of subjects who have EASI-90 (improvement of ≥90% in EASI score from Baseline)
Time Frame: Weeks 12, 16, 20 and 24
|
An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index).
The minimum EASI score is 0 and the maximum EASI score is 72.
Higher scores mean worse outcome.
|
Weeks 12, 16, 20 and 24
|
Percentage of subjects who have the Investigator's Global Assessment (IGA) score of 0 or 1
Time Frame: Weeks 12, 16, 20 and 24
|
This assessment is the overall investigator's overall global assessment for the whole body.
Minimum 0 to Maximum 4. 0 means No inflammatory signs of atopic dermatitis, 4 means Marked erythema & Disease is widespread in extent.
|
Weeks 12, 16, 20 and 24
|
Percentage of subjects whose Investigator Global Assessment (IGA) score is decreased by 2 points or more
Time Frame: Weeks 12, 16, 20 and 24
|
This assessment is the overall investigator's overall global assessment for the whole body.
Minimum 0 to Maximum 4. 0 means No inflammatory signs of atopic dermatitis, 4 means Marked erythema & Disease is widespread in extent.
|
Weeks 12, 16, 20 and 24
|
Score change from Baseline on Pruritus Numerical Rating Scale (NRS)
Time Frame: Weeks 4, 8, 12, 16, 20 and 24
|
The NRS is comprised of two items and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch") in the average score of itch and the worst score of itch.
|
Weeks 4, 8, 12, 16, 20 and 24
|
Percentage of subjects whose Pruritus Numerical Rating Scale (NRS) is improved by 3 points or more
Time Frame: Weeks 12, 16, 20 and 24
|
The NRS is comprised of two items and represents the numbers 0 ("no itch") to 10 ("worst imaginable itch") in the average score of itch and the worst score of itch.
|
Weeks 12, 16, 20 and 24
|
Percentage change from Baseline in Body Surface Area (BSA) affected by Atopic Dermatitis (AD)
Time Frame: Weeks 4, 8, 12, 16, 20 and 24
|
BSA involvement of AD will be assessed for each part of the body using "Wallace rule of nines".
This BSA is not calculated by weight and height unlike usual BSA calculation, the Wallace rule of nines is a tool used in pre-hospital and emergency medicine to estimate the total body surface area (BSA) affected by a burn.
However, this study, the rule of nines will be used to measure the estimated BSA of atopic dermatitis.
|
Weeks 4, 8, 12, 16, 20 and 24
|
Score change from Baseline in the SCORing Atopic Dermatitis (SCORAD) index
Time Frame: Weeks 4, 8, 12, 16, 20 and 24
|
SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis).
Dermatologists may use this tool before and after treatment to determine whether the treatment has been effective.
Maximum value is up to 103 which is the worst outcome.
|
Weeks 4, 8, 12, 16, 20 and 24
|
Score change from Baseline in the Dermatology Life Quality Index (DLQI)
Time Frame: Weeks 4, 8, 12, 16, 20 and 24
|
The Dermatology Life Quality Index questionnaire is designed for use in adults.
The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
|
Weeks 4, 8, 12, 16, 20 and 24
|
Score change from Baseline the Patient-Oriented Eczema Measure (POEM)
Time Frame: Weeks 4, 8, 12, 16, 20 and 24
|
POEM scores are 0-2 (clear/almost clear); 3-7 (mild); 8-16 (moderate); 17-24 (severe); 25-28 (very severe)
|
Weeks 4, 8, 12, 16, 20 and 24
|
Change from Baseline in biomarker (Immunoglobulin E [IgE])
Time Frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
biomarkers will be evaluated from the baseline to each time point.
Unit of Measure is IU/mL.
|
Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
Change from Baseline in biomarker (eosinophil count)
Time Frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
biomarkers will be evaluated from the baseline to each time point.
Unit of measure is cells/μL.
|
Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
Change from Baseline in biomarker (interleukin [IL]-13)
Time Frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
biomarkers will be evaluated from the baseline to each time point.
Unit of measure is pg/mL.
|
Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
Change from Baseline in biomarker (interleukin [IL]-17)
Time Frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
biomarkers will be evaluated from the baseline to each time point.
Unit of measure is pg/mL.
|
Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
Change from Baseline in biomarker (thymus and activation-regulated chemokine [TARC])
Time Frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
biomarkers will be evaluated from the baseline to each time point.
Unit of measure is pg/mL.
|
Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
Change from Baseline in biomarker (interleukin [IL]-22)
Time Frame: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
biomarkers will be evaluated from the baseline to each time point.
Unit of measure is pg/mL.
|
Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gwang Seong Choi, MD-Ph.D, Inha University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- ADT2002
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.
Clinical Trials on Dermatitis, Atopic
-
Catalysis SLCompletedAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related Conditions | Atopic Dermatitis \(AD\)Serbia
-
Jacob Pontoppidan ThyssenThe Novo Nordic FoundationRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis FlareDenmark
-
ShaperonRecruitingAtopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis of ScalpUnited States
-
University of California, San FranciscoSanofi; Regeneron PharmaceuticalsRecruitingEczema | Atopic Dermatitis | Atopic Dermatitis Eczema | Atopic Dermatitis and Related ConditionsUnited States
-
PfizerActive, not recruitingEczema | Atopic Dermatitis | Eczema, Atopic | Atopic Dermatitis, UnspecifiedUnited States, Canada, Czechia, Poland
-
AmgenCompletedDermatitis, Atopic DermatitisCanada, United States, Japan
-
Hadassah Medical OrganizationUnknownATOPIC DERMATITIS
-
National Institute of Allergy and Infectious Diseases...Atopic Dermatitis Research NetworkCompletedAtopic Dermatitis (AD) | Non-atopic Healthy ControlsUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...ZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruitingAtopic Dermatitis | Atopic Dermatitis EczemaNetherlands
-
AbbVieActive, not recruiting
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States