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

NCT06855745 | Recruiting Phase 2 DMC

• 1 other identifier: AB-101-003-00
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Atopic Dermatitis Eczema; Atopic Dermatitis; Atopic Dermatitis (AD); Eczema; Eczema, Atopic

Keywords

Eczema; Childhood eczema; Adult eczema; AD; Dermatitis; Infected dermatitis

Outcome Measures

Primary Outcomes (1)

• To 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.

  113 days

Secondary Outcomes (6)

• To evaluate the safety and tolerability of zabalafin hydrogel versus vehicle.

  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.

  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.

  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.

  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.

  113 days

Study Arms (2)

Arm A

EXPERIMENTAL

Zabalafin 9.5%

Drug: zabalafin

Arm B

PLACEBO COMPARATOR

Placebo (vehicle)

Drug: zabalafin

Interventions

zabalafin DRUG

Active IP

Also known as: AB-101

Arm A; Arm B

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/female participants who are ≥2 years of age on the day of providing documented informed consent/assent.
• Have a clinical diagnosis of Atopic Dermatitis (AD) according to the criteria of Hanifin and Rajka (1980) at the Screening visit and a history of AD for at least 6 months (3 months for children under the age of 6).
• Mild to moderate AD indicated by vIGA (Validated Investigator's Global Assessment) score of 2 (mild) or 3 (moderate) at Screening and at Day 1 prior to application of study intervention.
• Have AD on the head (including face, but excluding hair-bearing scalp), neck, trunk (excluding groin and genitals), or limbs, covering at least ≥2% of total BSA (body surface area) and not more than 20% at Screening and at Day 1 (Visit 1).
• Participants who have at least 1 lesion that measures approximately 5 cm2 or more at Screening and Day 1. Lesion must be representative of the participant's atopic dermatitis and not be located on the hands, feet, or genitalia.
• Have an Eczema Area and Severity Index (EASI) total score of ≥3 to ≤21 at Screening and at Day 1.
• Have a peak pruritus Numeric Rating Scale (NRS) score of at least 4 at Screening and at Day 1.
• All allowed oral and topical medications (Protocol Section 6.5) must be stable regimens within the 14 days prior to Day 1.
• Willing to refrain from using any topical products, including cosmetics and skin cleansers on the AD lesions during the study intervention application period (Section 6.5.1).
• Participants who are willing and able to comply with all study procedures, including scheduled visits, proper administration of study intervention application, lifestyle considerations.
• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• Not a woman of childbearing potential (WOCBP) OR
• A WOCBP who agrees to follow the contraceptive guidance in Section 10.4. Male participants are eligible to participate if they agree to follow the contraceptive guidance

You may not qualify if:

• Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
• Concurrent conditions and history of other diseases:
• Any other concomitant skin disorder, pigmentation, or extensive scarring that, in the opinion of the investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
• The presence of AD lesions only on the hands or feet without prior history of involvement of other classical areas of involvement such as the face or the folds.
• Other types of atopic dermatitis.
• Has recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD in the opinion of the investigator
• Ultraviolet (UV) light therapy or prolonged exposure to artificial sources of UV radiation within 2 weeks prior to Screening and/or intention to have such exposure during the study.
• Use of any of the following treatments within the indicated washout period before Day
• half-lives or 12 weeks, whichever is longer - biologic agents (e.g. dupilumab).
• weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g. mycophenolate or tacrolimus).
• Two weeks - systemic antibiotics.
• One week - use of other topical treatments for AD (other than bland emollients).
• One week - topical antiviral agents, topical antibacterial agents, topical antifungal agents, topical corticosteroid agents.
• One week - oral antibiotics
• Has undergone treatment within 5 years for any cancer except non-melanoma skin cancers, squamous cell carcinoma, basal cell carcinoma. Participants with adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ are allowed.

Sponsors & Collaborators

• Alphyn Biologics: lead

Study Sites (12)

Canopy Clinical Northern Beaches

Brookvale, New South Wales, 2100, Australia

RECRUITING

Momentum Clinical Research

Darlinghurst, New South Wales, 2010, Australia

RECRUITING

Premier Specialists

Kogarah, New South Wales, 2217, Australia

RECRUITING

St George Dermatology

Kogarah, New South Wales, 2217, Australia

RECRUITING

Novatrials

Kotara, New South Wales, 2289, Australia

RECRUITING

Innovate Clinical Research

Waitara, New South Wales, 2077, Australia

RECRUITING

Canopy Clinical Wollongong

Wollongong, New South Wales, 2500, Australia

RECRUITING

The Skin Center

Benowa, Queensland, 4217, Australia

RECRUITING

Momentum Clinical Research

Wellers Hill, Queensland, 4012, Australia

RECRUITING

Veracity Clinical Research

Woolloongabba, Queensland, 4102, Australia

RECRUITING

Canopy Clinical Altona North

North Altona, Victoria, 3025, Australia

RECRUITING

Captain Stirling Medical Centre

Nedlands, Western Australia, 6009, Australia

RECRUITING

Related Links

• Alphyn announces positive results from second cohort of phase 2a clinical trial in atopic dermatitis. News release. PR Newswire. March 7, 2024.
• Alphyn Granted U.S. Patent Covering First-in-Class Treatment for Atopic Dermatitis

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gary Pekoe, PhD

  Alphyn Biologics

  STUDY DIRECTOR

Central Study Contacts

Dr. Lynda Spelman

CONTACT

+61730391311; trials@veracityclinicalresearch.com.au

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomised, double blind study aiming to enrol 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.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 4, 2025
• Study Start: March 25, 2025
• Primary Completion: October 30, 2025
• Study Completion: November 28, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (12)