A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Active IP
Canopy Clinical Northern Beaches
Brookvale, New South Wales, Australia
RECRUITINGMomentum Clinical Research
Darlinghurst, New South Wales, Australia
RECRUITINGTo evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by vIGA.
Proportion of participants who achieve Validated Investigator's Global Assessment (vIGA) "clear or almost clear" with a 2-grade improvement from baseline at Day 113.
Time frame: 113 days
To evaluate the safety and tolerability of zabalafin hydrogel versus vehicle.
* Frequency and severity of Adverse Events (AEs) * Study intervention discontinuation due to AEs.
Time frame: 113 days
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by absolute change in Eczema area and severity index (EASI) score.
Absolute change in EASI score at Days 15, 29, 57, 85, and 113.
Time frame: 113 days
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by vIGA, where response is defined as achieving at least a 1-point decrease from baseline in vIGA score.
Proportion of participants achieving at least a 1-point decrease in vIGA score at Days 15, 29, 57, 85, and 113
Time frame: 113 days
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by peak pruritus numerical rating score (NRS), where response is defined as achieving at least a 4-point decrease from baseline.
Proportion of participants achieving at least a ≥4-point decrease in peak pruritus NRS at Days 15, 29, 57, 85, and 113.
Time frame: 113 days
To evaluate the efficacy of zabalafin hydrogel compared with vehicle as assessed by Patient oriented eczema measure (POEM) Score, where response is defined as achieving at least a 6-point decrease from baseline.
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Premier Specialists
Kogarah, New South Wales, Australia
RECRUITINGSt George Dermatology
Kogarah, New South Wales, Australia
RECRUITINGNovatrials
Kotara, New South Wales, Australia
RECRUITINGInnovate Clinical Research
Waitara, New South Wales, Australia
RECRUITINGCanopy Clinical Wollongong
Wollongong, New South Wales, Australia
RECRUITINGThe Skin Center
Benowa, Queensland, Australia
RECRUITINGMomentum Clinical Research
Wellers Hill, Queensland, Australia
RECRUITINGVeracity Clinical Research
Woolloongabba, Queensland, Australia
RECRUITING...and 2 more locations
Proportion of participants achieving at least a ≥6-point decrease in POEM at Days 15, 29, 57, 85, and 113.
Time frame: 113 days
To evaluate the antibacterial efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD (Cohort 2).
* Clinical assessment of infection at Days 4, 15, 29, 57, 85, and 113. * Bacteriologic assessment of infection at Days 4, 15, 29, 57, 85, and 113.
Time frame: 113 days