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

NCT04179760 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-06-08

No results posted yet for this study

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

Interventions

BIOLOGICAL

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).

OTHER

Placebo

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).

Sponsors & Collaborators

  • SCM Lifescience Co., LTD.

    lead INDUSTRY

Principal Investigators

  • Gwang Seong Choi, MD-Ph.D · Inha University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-24
Primary Completion
2022-08-02
Completion
2022-10-26

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04179760 on ClinicalTrials.gov