Actively Recruiting
Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.
Led by Alphyn Biologics · Updated on 2025-08-01
72
Participants Needed
12
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).
CONDITIONS
Official Title
Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 2 years or older at consent
- Clinical diagnosis of atopic dermatitis with a history of at least 6 months (3 months for children under 6 years)
- Mild to moderate atopic dermatitis with vIGA score of 2 or 3 at screening and Day 1
- Atopic dermatitis affecting head, neck, trunk (excluding groin/genitals), or limbs covering 2% to 20% body surface area
- At least one lesion of approximately 5 cm2 or larger, not on hands, feet, or genitalia
- Eczema Area and Severity Index (EASI) score between 3 and 21 at screening and Day 1
- Peak itch (pruritus) score of at least 4 at screening and Day 1
- Stable use of allowed oral and topical medications for at least 14 days before Day 1
- Willing to avoid other topical products on affected areas during treatment
- Able and willing to comply with all study procedures and visits
- Females must not be pregnant or breastfeeding and either not of childbearing potential or agree to follow contraceptive guidelines
- Males must agree to follow contraceptive guidelines
You will not qualify if you...
- Unstable or rapidly changing atopic dermatitis in the 4 weeks before Day 1
- Other skin disorders, pigmentation issues, or scarring affecting assessment
- Atopic dermatitis only on hands or feet without other typical areas involved
- Other types of atopic dermatitis
- Recent or planned treatments that may affect atopic dermatitis course
- UV light therapy or artificial UV exposure within 2 weeks before screening or planned during study
- Use of biologic agents within 12 weeks or 5 half-lives before Day 1
- Use of systemic corticosteroids or immunosuppressants within 4 weeks before Day 1
- Use of systemic antibiotics within 2 weeks before Day 1
- Use of topical treatments for atopic dermatitis (except bland emollients) within 1 week before Day 1
- Treatment for cancer (except certain skin cancers) within last 5 years
- Other active skin conditions that may interfere with evaluation
- Severe or uncontrolled major organ diseases or infections in past 3 months
- Recent use of significant systemic therapies judged clinically important
- Major surgery or trauma within 3 months before screening or planned during study
- Hypersensitivity to zabalafin or hydrogel components
- Uncontrolled or severe depression, suicidal thoughts, or behavior
- Positive pregnancy test within 24 hours before randomization
- Live vaccines within 30 days before treatment; certain COVID-19 vaccines allowed
- Participation in another investigational drug trial within 90 days
- Investigator site staff or family members involved in the study
- History of substance or alcohol abuse in past 6 months
- Any medical or psychiatric condition that poses risk or interferes with study participation or results interpretation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Canopy Clinical Northern Beaches
Brookvale, New South Wales, Australia, 2100
Actively Recruiting
2
Momentum Clinical Research
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
3
Premier Specialists
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
4
St George Dermatology
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
5
Novatrials
Kotara, New South Wales, Australia, 2289
Actively Recruiting
6
Innovate Clinical Research
Waitara, New South Wales, Australia, 2077
Actively Recruiting
7
Canopy Clinical Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
8
The Skin Center
Benowa, Queensland, Australia, 4217
Actively Recruiting
9
Momentum Clinical Research
Wellers Hill, Queensland, Australia, 4012
Actively Recruiting
10
Veracity Clinical Research
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
11
Canopy Clinical Altona North
North Altona, Victoria, Australia, 3025
Actively Recruiting
12
Captain Stirling Medical Centre
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
D
Dr. Lynda Spelman
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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