A Phase II Study of HY209 Gel for Atopic Dermatitis Patients (Shaperon)

Summary

A Randomized, Double-blinded, Placebo-controlled, Parallel, Multi-Center Phase II Clinical Study to Evaluate the Efficacy and Safety of HY209 gel for Patients with Atopic Dermatitis

Timeline

Start

2020-08-26

Primary completion

2021-09-07

Completion

2021-09-07

Outcome

Missed primary endpoint

release “㈜샤페론(378800)은 아토피 피부염 치료제 후보물질 ‘누겔(NuGel, HY209gel)’의 미국·한국 임상 2상(Part 1 33명, Part 2 175명, 총 208명) 최종 결과보고서(CSR)를 수령했다고 1일 밝혔다. 이번 임상에서 1차 평가지표는 충족하지 못했으나,” shaperon.com ↗

Publications

• Baek GH, Kim BR, Shin JW, Huh CH, Hwang J, Ko S, Kim S, Ho PS, Kim KH, Park CW, Seo SJ, Park CO, Shin D, Kim Y, Kim Y, Seong SY, Na JI. A phase 2a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of NuGel, a novel topical GPCR19-mediated inflammasome inhibitor, in patients with mild to moderate atopic dermatitis: a proof-of-concept study with Post-hoc biomarker analysis. Front Immunol. 2025 May 19;16:1560447. doi: 10.3389/fimmu.2025.1560447. eCollection 2025.

Drugs

Indications