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Compares treatment options for Atopic Dermatitis (Eczema)
Official title Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.
ClinicalTrials.gov ID: NCT06855745
What this study is testing
What is zabalafin?
zabalafin is an investigational medicine, given as a monthly treatment applied to the skin, being studied as a potential treatment for atopic dermatitis (eczema).
Also referred to as AB-101.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).
- Phase 2: a mid-size study of how well it works
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join 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...
- 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...
- Have AD on the head (including face, but excluding hair-bearing scalp), neck, trunk (excluding groin and genitals), or limbs, covering at least ≥2%...
- 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...
You likely can't join 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...
- 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...
- 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
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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
What rules you out
- 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
- 5 half-lives or 12 weeks, whichever is longer - biologic agents (e.g. dupilumab).
- 4 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...
- Active or potentially recurrent dermatologic condition other than AD that may confound evaluation in the opinion of the investigator.
- Current or recent history (within 3 months) of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
- Have had a systemic infection within the past 3 months requiring hospitalization.
- Have required the use of parenteral antimicrobial, antivirals, antiprotozoals, antifungals, janus kinase inhibitors (JAK), tyrosine kinase inhibitors (TYK2, or phosphodiesterase 4 (PDE4) inhibitors, monoclonal...
- Has undergone significant trauma or major surgery within 3 months prior to screening or has major surgery planned during the study.
- Known hypersensitivity to zabalafin or any component of the hydrogel vehicle.
- Has a presence of depression per the Depression and Anxiety Disorder Score (DASS) scale that is not controlled with medication or is in remission, or the presence of severe depression or suicidal ideation or behavior...
- A WOCBP who has a positive serum pregnancy test within 24 hours prior to randomization or treatment allocation. Note: If 24 hours have elapsed between the screening pregnancy test and the first dose of study...
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Administration of killed vaccine and mRNA vaccines are allowed. Note: Any licensed COVID-19 vaccine (including...
- Current treatment or treatment within 90 days or 5 half-lives (whichever is longer) before Day 1 with another investigational medication or current enrollment in another investigational drug protocol. Other Exclusion...
- Investigator site staff members directly involved in the conduct of the study and their family members; site staff members otherwise supervised by the investigator, are not eligible.
- Has a history of alcohol or substance abuse within 6 months prior to Screening that in the opinion of the investigator will preclude participation in the study.
- Have any medical or psychiatric condition which, in the opinion of the Investigator or the Sponsor's Medical Monitor, would place the participant at risk, interfere with participation in the study, or interfere with the...
The study team makes the final eligibility decision.
Where it's taking place
- Brookvale, New South Wales, Australia
- Darlinghurst, New South Wales, Australia
- Kogarah, New South Wales, Australia
- Kotara, New South Wales, Australia
- Waitara, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Benowa, Queensland, Australia
- Wellers Hill, Queensland, Australia
- Woolloongabba, Queensland, Australia
- North Altona, Victoria, Australia
- Nedlands, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Brookvale, New South Wales, Australia; Darlinghurst, New South Wales, Australia; Kogarah, New South Wales, Australia; Kotara, New South Wales, Australia; Waitara, New South Wales, Australia; Wollongong, New South Wales, Australia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.