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

NCT04179760 | Completed Phase 1

• 1 other identifier: ADT2002
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (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.

  Week 12

Secondary Outcomes (17)

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

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

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

  Weeks 12, 16, 20 and 24

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

  Weeks 12, 16, 20 and 24

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

  Weeks 12, 16, 20 and 24

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

  Weeks 12, 16, 20 and 24

Study Arms (2)

SCM-AGH

EXPERIMENTAL

* Ingredient: Allogeneic human bone marrow-derived mesenchymal stem cells * Dose: 1x10\^6 cells/Kg

Biological: SCM-AGH

Placebo

PLACEBO COMPARATOR

3 times with 2-week intervals by IV infusion.

Other: Placebo

Interventions

SCM-AGH BIOLOGICAL

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).

SCM-AGH

Placebo OTHER

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).

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• SCM Lifescience Co., LTD.: lead

Study Sites (1)

Inha University Hospital

Incheon, South Korea

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gwang Seong Choi, MD-Ph.D

  Inha University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I: Multicenter in Korea, Randomized, Open-label, Parallel arm Phase II: Multicenter in Korea, Double-blind, Placebo-controlled, Parallel arm

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 27, 2019
• Study Start: March 24, 2020
• Primary Completion: August 2, 2022
• Study Completion: October 26, 2022
• Last Updated: June 8, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)