NCT06855745

Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.

A Phase 2, Randomized, Double-blind, Multicenter Study to Assess the Safety and Efficacy of Topical Zabalafin Hydrogel Versus Vehicle in the Treatment of Participants With Mild to Moderate Atopic Dermatitis (CLEAR-AD1)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Alphyn Biologics · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).

Detailed description

This is a randomised, double blind study aiming to enroll 72 participants across 10 sites in Australia. There are 2 cohorts: Cohort 1: Mild to moderate atopic dermatitis Cohort 2: Mild to moderate atopic dermatitis - with secondary skin infection. Once assigned to a cohort participants will be randomised into 1 of 2 Groups: Arm A: Zabalafin hydrogel or Arm B: vehicle (placebo). Randomisation will be 2:1 ratio. There is up to 2 weeks for screening and study treatment period of 16 weeks. Participants will need to attend the site every 2 weeks for 1 month and then monthly until Week 16 (end of study treatment). The primary objective (efficacy) will be assessed using validated Investigators Global Assessment scale (vIGA).

Conditions

• Atopic Dermatitis (Eczema)
• Atopic Dermatitis Eczema
• Atopic Dermatitis
• Atopic Dermatitis (AD)
• Eczema
• Eczema, Atopic

Interventions

Type	Name	Description
DRUG	zabalafin	Active IP

Timeline

• Start date: 2025-03-25
• Primary completion: 2025-10-30
• Completion: 2025-11-28
• First posted: 2025-03-04
• Last updated: 2025-08-01

Locations

12 sites across 1 country: Australia