NCT06024499

Phase 2 Trial of HY209gel in Atopic Dermatitis Patients

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Shaperon · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.

Detailed description

Part 1 (2 cohorts): Total 33 subjects * Cohort A: 15 subjects (6 HY209gel 0.5%, 6 HY209gel 1%, and 3 placebo) * Cohort B: 9 subjects (6 HY209gel 2%, and 3 placebo) * Cohort C: 9 subjects (6 HY209gel 4%, and 3 placebo) Part 2 (3 treatment groups): Total 177 subjects * Low dose of HY209gel: 59 subjects * High dose of HY209gel: 59 subjects * Placebo (Vehicle): 59 subjects Part 1 is a dose-escalation part of HY209gel using lower doses of HY209gel (0.5% and 1%) with escalation (HY209gel 2% and 4%) to evaluate the pharmacokinetics(PK), safety, and tolerability of HY209gel treatment. Escalation to the next dose level will be decided by the Safety Monitoring Committee(SMC) that will review all available safety data of the planned dose level within the timeline specified on SMC charter after all enrolled subjects of each cohort complete 2-week treatment and determine the escalation to the next dose to be safe. Based on the interim analysis for 4-week safety and efficacy data collected from Part 1, two doses will be selected for use in Part 2, which will enroll up to 177 subjects in 3 treatment arms (59 subjects per treatment arm) to evaluate the efficacy and safety of HY209gel, compared to placebo (vehicle) for 8-week treatment period.

Conditions

• Atopic Dermatitis
• Atopic Dermatitis Eczema
• Atopic Dermatitis of Scalp

Interventions

Type	Name	Description
DRUG	HY209GEL Active	Selected two among four doses (HY209GEL 0.5% or 1% or 2% or 4%) in PART1
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-06-30
• Completion: 2026-08-31
• First posted: 2023-09-06
• Last updated: 2026-02-23

Locations

12 sites across 2 countries: United States, South Korea

Regulatory

• FDA-regulated drug study