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

Dermatitis, Atopic Clinical Trial

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

Status Completed

Clinical 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

• NCT number: NCT04179760
• Study type: Interventional
• Source: SCM Lifescience Co., LTD.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 24, 2020
• Completion date: October 26, 2022