NCT04179760

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: SCM Lifescience Co., LTD. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-03-24
• Primary completion: 2022-08-02
• Completion: 2022-10-26
• First posted: 2019-11-27
• Last updated: 2023-06-08

Locations

1 site across 1 country: South Korea