Atopic Dermatitis (Eczema)Phase 2CLEAR-AD1NCT06855745
Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.
A Phase 2 study testing zabalafin in people with Atopic Dermatitis (Eczema) and Atopic Dermatitis Eczema, run by Alphyn Biologics at 12 sites in Australia.
Trial summary
A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema). Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Atopic Dermatitis (Eczema), Atopic Dermatitis Eczema, Atopic Dermatitis
- What is being tested?
- zabalafin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 12 sitesAustralia
- Study dates
- 25 Mar 2025to 28 Nov 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to 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 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.
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 32Show fewer
- 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 squamous cell cancer of the skin, or cervical carcinoma in situ are allowed.
- 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 antibodies (mABs), or other parenteral therapies as judged to be clinically significant by the Investigator within the past 3 months.
- 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. Participants with severe depression/suicidal ideation/behavior should be referred to appropriate medical professionals for evaluation.
- 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 intervention, another serum pregnancy test must be performed and must be negative for participant to start receiving study intervention.
- 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 for Emergency Use) is allowed in the study if they are Messenger Ribonucleic Acid (mRNA) vaccines, replication-incompetent adenoviral vaccines, or inactivated vaccines. These vaccines will be treated just as any other concomitant therapy. Investigational vaccines (ie, those not licensed or approved for Emergency Use) are not allowed.
- Prior/Concurrent Clinical Study Experience:
- 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 Criteria:
- 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 interpretation of study results.
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Australia12 sites, 12 recruiting
- Recruiting
The Skin Center
Benowa, Queensland, 4217
Dr Michael Freeman, +61 7 5597 7170, michael@skincentre.com.au
- Recruiting
Canopy Clinical Northern Beaches
Brookvale, New South Wales, 2100
Dr Deon Smith, +61 1300 55 96 76, dsmith@northernbeachesclinicalresearch.com
- Recruiting
Momentum Clinical Research
Darlinghurst, New South Wales, 2010
Dr Madeleine Janin, +61 2 8038 1044, maddie.janin@momentumclinicalresearch.com
- Recruiting
Premier Specialists
Kogarah, New South Wales, 2217
Prof Dedee Murrell, +61 2 9598 5800, premierspectrialsprofmurrell@gmail.com
- Recruiting
St George Dermatology
Kogarah, New South Wales, 2217
Dr Esther Hong, +61 2 9587 4277, ehon8261@med.usyd.edu.au
- Recruiting
Novatrials
Kotara, New South Wales, 2289
Dr Juliana Junger, +61 2 4063 3381, juliana@novatrials.com.au
- Recruiting
Captain Stirling Medical Centre
Nedlands, Western Australia, 6009
Dr Michael Benson, +61 8 9386 1858, michaelbenson@csmc.net.au
- Recruiting
Canopy Clinical Altona North
North Altona, Victoria, 3025
Dr Oscar Walsh, +61 1300 55 96 76, owalsh@altonaclinicalresearch.com
- Recruiting
Innovate Clinical Research
Waitara, New South Wales, 2077
Dr Linda Chan, +61 2 9159 3838, lchan@innovateclinical.com.au
- Recruiting
Momentum Clinical Research
Wellers Hill, Queensland, 4012
Dr Ellie Ngoh, +61 7 3517 0529, Ellie.Ngoh@momentumclinicalresearch.com.au
- Recruiting
Canopy Clinical Wollongong
Wollongong, New South Wales, 2500
Dr Tess Tonkin, +61 1300 112 708, ttonkin@wollongongclinicalreseach.com
- Recruiting
Veracity Clinical Research
Woolloongabba, Queensland, 4102
Prof Lynda Spelman, +61 7 3039 1311, spelchat@veracity.net.au
About this study
Official title: 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)
A Phase 2b study investigating the efficacy of zabalafin in people with mild to moderate atopic dermatitis (eczema).
Read the 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
- Being tested
- zabalafin
- Keywords
- Eczema, Childhood eczema, Adult eczema, AD, Dermatitis, Infected dermatitis
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zabalafinDrug
Also called AB-101
Active IP
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Zabalafin 9.5% Receives: Drug: zabalafin |
| Arm B | Placebo comparator | Placebo (vehicle) Receives: Drug: zabalafin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 113 days
Secondary outcomes (6)
To evaluate the safety and tolerability of zabalafin hydrogel versus vehicle.
- Frequency and severity of Adverse Events (AEs)
- Study intervention discontinuation due to AEs.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Proportion of participants achieving at least a ≥6-point decrease in POEM at Days 15, 29, 57, 85, and 113.
Measured: 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.
Measured: 113 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start25 Mar 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion28 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (Eczema)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alphyn Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Pekoe, PhD, Study director, Alphyn Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855745
- Sponsor's protocol ID
- AB-101-003-00
- Acronym
- CLEAR-AD1
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06855745
- Acronym / sponsor ID
- CLEAR-AD1 / AB-101-003-00
- Conditions
- Atopic Dermatitis (Eczema), Atopic Dermatitis Eczema, Atopic Dermatitis, Atopic Dermatitis (AD), Eczema, Eczema, Atopic
- Keywords
- Eczema, Childhood eczema, Adult eczema, AD, Dermatitis, Infected dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Alphyn BiologicsIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 28 Nov 2025 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: zabalafinZabalafin 9.5% |
| Arm B | Placebo comparator | Drug: zabalafinPlacebo (vehicle) |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (32 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zabalafinAlso: AB-101Active IP | Drug | Arm A, Arm B |
Primary outcome
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by vIGA.
Time frame: 113 days
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.
6 secondary outcomes
To evaluate the safety and tolerability of zabalafin hydrogel versus vehicle.
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.
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.
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.
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.
Time frame: 113 days
To evaluate the antibacterial efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD (Cohort 2).
Time frame: 113 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Alphyn announces positive results from second cohort of phase 2a clinical trial in atopic dermatitis. News release. PR Newswire. March 7, 2024.Link provided by the sponsor.
- Alphyn Granted U.S. Patent Covering First-in-Class Treatment for Atopic DermatitisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gary Pekoe, PhD study director
Alphyn Biologics
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zabalafin in people with Atopic Dermatitis (Eczema) and Atopic Dermatitis Eczema, run by Alphyn Biologics at 12 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Lynda Spelman (+61730391311, trials@veracityclinicalresearch.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by vIGA. (time frame: 113 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.