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Dermatitis, AtopicPhase 1/2NCT04179760

Safety and Efficacy of SCM-AGH in Subjects With Moderate to Severe Atopic Dermatitis

A Phase 1/2 study testing SCM-AGH in people with Dermatitis, Atopic, run by SCM Lifescience Co., LTD. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Dermatitis, Atopic
What is being tested?
SCM-AGH
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteSouth Korea
Study dates
24 Mar 2020to 26 Oct 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Inha University Hospital

    Incheon

Other trials in South Korea

About this study

Official title: 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

Read the 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.

Being tested
SCM-AGH, Placebo
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCM-AGHBiological

    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).

  • PlaceboOther

    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).

Study groups in NCT04179760
Study groupRoleWhat they receive
SCM-AGHExperimental* Ingredient: Allogeneic human bone marrow-derived mesenchymal stem cells * Dose: 1x10^6 cells/Kg
Receives: Biological: SCM-AGH
PlaceboPlacebo comparator3 times with 2-week intervals by IV infusion.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)

    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.

    Measured: Week 12

Secondary outcomes (17)

  1. Score change from Baseline in Eczema Area and Severity Index(EASI) score

    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.

    Measured: Weeks 4, 8, 12, 16, 20 and 24

  2. Percentage of subjects who have EASI-75 (improvement of ≥75% in EASI score from Baseline)

    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.

    Measured: Weeks 12, 16, 20 and 24

  3. Percentage of subjects who have EASI-90 (improvement of ≥90% in EASI score from Baseline)

    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.

    Measured: Weeks 12, 16, 20 and 24

  4. Percentage of subjects who have the Investigator's Global Assessment (IGA) score of 0 or 1

    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.

    Measured: Weeks 12, 16, 20 and 24

  5. Percentage of subjects whose Investigator Global Assessment (IGA) score is decreased by 2 points or more

    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.

    Measured: Weeks 12, 16, 20 and 24

  6. Score change from Baseline on Pruritus Numerical Rating Scale (NRS)

    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.

    Measured: Weeks 4, 8, 12, 16, 20 and 24

  7. Percentage of subjects whose Pruritus Numerical Rating Scale (NRS) is improved by 3 points or more

    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.

    Measured: Weeks 12, 16, 20 and 24

  8. Percentage change from Baseline in Body Surface Area (BSA) affected by Atopic Dermatitis (AD)

    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.

    Measured: Weeks 4, 8, 12, 16, 20 and 24

  9. Score change from Baseline in the SCORing Atopic Dermatitis (SCORAD) index

    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.

    Measured: Weeks 4, 8, 12, 16, 20 and 24

  10. Score change from Baseline in the Dermatology Life Quality Index (DLQI)

    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.

    Measured: Weeks 4, 8, 12, 16, 20 and 24

  11. Score change from Baseline the Patient-Oriented Eczema Measure (POEM)

    POEM scores are 0-2 (clear/almost clear); 3-7 (mild); 8-16 (moderate); 17-24 (severe); 25-28 (very severe)

    Measured: Weeks 4, 8, 12, 16, 20 and 24

  12. Change from Baseline in biomarker (Immunoglobulin E [IgE])

    biomarkers will be evaluated from the baseline to each time point. Unit of Measure is IU/mL.

    Measured: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24

  13. Change from Baseline in biomarker (eosinophil count)

    biomarkers will be evaluated from the baseline to each time point. Unit of measure is cells/μL.

    Measured: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24

  14. Change from Baseline in biomarker (interleukin [IL]-13)

    biomarkers will be evaluated from the baseline to each time point. Unit of measure is pg/mL.

    Measured: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24

  15. Change from Baseline in biomarker (interleukin [IL]-17)

    biomarkers will be evaluated from the baseline to each time point. Unit of measure is pg/mL.

    Measured: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24

  16. Change from Baseline in biomarker (thymus and activation-regulated chemokine [TARC])

    biomarkers will be evaluated from the baseline to each time point. Unit of measure is pg/mL.

    Measured: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24

  17. Change from Baseline in biomarker (interleukin [IL]-22)

    biomarkers will be evaluated from the baseline to each time point. Unit of measure is pg/mL.

    Measured: Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Nov 2019
  2. Study start24 Mar 2020
  3. Primary completion2 Aug 2022
  4. Study completion26 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase I: Multicenter in Korea, Randomized, Open-label, Parallel arm Phase II: Multicenter in Korea, Double-blind, Placebo-controlled, Parallel arm
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04179760
Sponsor's protocol ID
ADT2002
Status last verified
Jun 2023
First submitted
20 Nov 2019
Last updated
8 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SCM-AGH in people with Dermatitis, Atopic, run by SCM Lifescience Co., LTD. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50) (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04179760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.

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