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Safety and Efficacy of SCM-AGH in Subjects With Moderate to Severe Atopic Dermatitis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT04179760•SCM Lifescience Co., LTD.

View on ClinicalTrials.gov

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.

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects who are males or females aged \>= 19 years
•2. Subjects who are diagnosed with Atopic Dermatitis (AD) based on the Eichenfield revised criteria of Hannifin and Rajka that
•1. has been present for at least 1 year before the Screening visit, and
•2. have chronic AD symptoms continually for at least 6 months before Screening visit
•3. Subjects who have moderate to severe AD (EASI ≥16) at the Screening visit and Baseline visit
•4. Subjects who have IGA score ≥3 at the Screening and Baseline visits
•5. Subjects who have at least 10% of total body surface area affected by AD at the Screening and Baseline visits
•6. Subjects who can give written informed consent
•7. 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
•8. 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.
+7 more criteria

Exclusion Criteria

•1. Systemic infection or local infection requiring prohibited medications at Screening visit
•2. 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:
•1. Use of immunosuppressive/ immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ (interferon-gamma), Janus kinase inhibitors, azathioprine, methotrexate)
•2. Phototherapy for AD
•3. Any other systemic therapy used to treat AD or symptoms of AD (approved or off-label use)
•3. Use of topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within at least 2 weeks prior to Baseline
•4. History of anaphylaxis to any biologic therapy or vaccine
•5. History of Guillain-Barré syndrome
•6. Receipt of immunoglobulin or blood products within 30 days prior to the date informed consent is obtained
•7. Any allergen immunotherapy within 4 months prior to or throughout the study
+19 more criteria

Locations (1)

Inha University Hospital

Incheon, South Korea

Key Dates

Start Date

March 24, 2020

Primary Completion Date

August 2, 2022

Completion Date

October 26, 2022

Last Updated

June 8, 2023

Enrollment

ACTUAL participants

Conditions

Dermatitis, Atopic

Interventions

SCM-AGH

BIOLOGICAL

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 8, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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