A Randomized, Phase I/II Trial to Evaluate the Safety and Efficacy of SCM-AGH in Subjects With Moderate to Severe Atopic Dermatitis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dermatitis, Atopic
- Sponsor
- SCM Lifescience Co., LTD.
- Enrollment
- 92
- Locations
- 1
- Primary Endpoint
- over 50% reduction ratio of Eczema Area and Severity Index (EASI) as contrasted with baseline value (EASI-50)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
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.
Investigators
Eligibility Criteria
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.
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Percentage of subjects who have EASI-90 (improvement of ≥90% in EASI score from Baseline)(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)
- Score change from Baseline in the Dermatology Life Quality Index (DLQI)(Weeks 4, 8, 12, 16, 20 and 24)
- Change from Baseline in biomarker (eosinophil count)(Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24)
- Change from Baseline in biomarker (interleukin [IL]-13)(Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24)
- 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 the Investigator's Global Assessment (IGA) score of 0 or 1(Weeks 12, 16, 20 and 24)
- Percentage of subjects whose Pruritus Numerical Rating Scale (NRS) is improved by 3 points or more(Weeks 12, 16, 20 and 24)
- Score change from Baseline in the SCORing Atopic Dermatitis (SCORAD) index(Weeks 4, 8, 12, 16, 20 and 24)
- Score change from Baseline the Patient-Oriented Eczema Measure (POEM)(Weeks 4, 8, 12, 16, 20 and 24)
- Change from Baseline in biomarker (interleukin [IL]-22)(Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24)
- Percentage change from Baseline in Body Surface Area (BSA) affected by Atopic Dermatitis (AD)(Weeks 4, 8, 12, 16, 20 and 24)
- Change from Baseline in biomarker (Immunoglobulin E [IgE])(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])(Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24)
- Score change from Baseline on Pruritus Numerical Rating Scale (NRS)(Weeks 4, 8, 12, 16, 20 and 24)
- Change from Baseline in biomarker (interleukin [IL]-17)(Week 4, Week 6, Week 8, Week 12, Week 16, Week 20 and Week 24)