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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06855745




Registration number
NCT06855745
Ethics application status
Date submitted
27/02/2025
Date registered
4/03/2025

Titles & IDs
Public title
Phase 2 Randomized Double-blind Study to Assess Topical Zabalafin Hydrogel Vs Vehicle in Mild to Moderate AD.
Scientific 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)
Secondary ID [1] 0 0
AB-101-003-00
Universal Trial Number (UTN)
Trial acronym
CLEAR-AD1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis (Eczema) 0 0
Atopic Dermatitis Eczema 0 0
Atopic Dermatitis 0 0
Atopic Dermatitis (AD) 0 0
Eczema 0 0
Eczema, Atopic 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - zabalafin

Experimental: Arm A - Zabalafin 9.5%

Placebo comparator: Arm B - Placebo (vehicle)


Treatment: Drugs: zabalafin
Active IP
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD as assessed by vIGA.
Timepoint [1] 0 0
113 days
Secondary outcome [1] 0 0
To evaluate the safety and tolerability of zabalafin hydrogel versus vehicle.
Timepoint [1] 0 0
113 days
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
113 days
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
113 days
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
113 days
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
113 days
Secondary outcome [6] 0 0
To evaluate the antibacterial efficacy of zabalafin hydrogel compared with vehicle in treating mild to moderate AD (Cohort 2).
Timepoint [6] 0 0
113 days

Eligibility
Key inclusion criteria
1. Male/female participants who are =2 years of age on the day of providing documented informed consent/assent.
2. 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).
3. 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.
4. 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).
5. 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.
6. Have an Eczema Area and Severity Index (EASI) total score of =3 to =21 at Screening and at Day 1.
7. Have a peak pruritus Numeric Rating Scale (NRS) score of at least 4 at Screening and at Day 1.
8. All allowed oral and topical medications (Protocol Section 6.5) must be stable regimens within the 14 days prior to Day 1.
9. 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).
10. Participants who are willing and able to comply with all study procedures, including scheduled visits, proper administration of study intervention application, lifestyle considerations.
11. 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
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to Day 1.
2. Concurrent conditions and history of other diseases:

1. 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.
2. 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.
3. Other types of atopic dermatitis.
3. Has recent or anticipated concomitant use of systemic or topical therapies that might alter the course of AD in the opinion of the investigator
4. 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.
5. Use of any of the following treatments within the indicated washout period before Day

1. 5 half-lives or 12 weeks, whichever is longer - biologic agents (e.g. dupilumab).
2. 4 weeks - systemic corticosteroids or adrenocorticotropic hormone analogs, cyclosporin, methotrexate, azathioprine, or other systemic immunosuppressive or immunomodulating agents (e.g. mycophenolate or tacrolimus).
3. Two weeks - systemic antibiotics.
4. One week - use of other topical treatments for AD (other than bland emollients).
5. One week - topical antiviral agents, topical antibacterial agents, topical antifungal agents, topical corticosteroid agents.
6. One week - oral antibiotics
6. 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.
7. Active or potentially recurrent dermatologic condition other than AD that may confound evaluation in the opinion of the investigator.
8. Current or recent history (within 3 months) of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiovascular, or neurological disease.
9. Have had a systemic infection within the past 3 months requiring hospitalization.
10. 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.
11. Has undergone significant trauma or major surgery within 3 months prior to screening or has major surgery planned during the study.
12. Known hypersensitivity to zabalafin or any component of the hydrogel vehicle.
13. 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.
14. 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.
15. 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:
16. 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
17. 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.
18. 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.
19. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
10/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/11/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Momentum Clinical Research - Darlinghurst
Recruitment hospital [2] 0 0
St George Dermatology - Kogarah
Recruitment hospital [3] 0 0
Novatrials - Kotara
Recruitment hospital [4] 0 0
Innovate Clinical Research - Waitara
Recruitment hospital [5] 0 0
The Skin Center - Benowa
Recruitment hospital [6] 0 0
Momentum Clinical Research - Wellers Hill
Recruitment hospital [7] 0 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [8] 0 0
Altona Clinical Research - Altona North
Recruitment hospital [9] 0 0
Captain Stirling Medical Centre - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2289 - Kotara
Recruitment postcode(s) [4] 0 0
2077 - Waitara
Recruitment postcode(s) [5] 0 0
4217 - Benowa
Recruitment postcode(s) [6] 0 0
4012 - Wellers Hill
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
3025 - Altona North
Recruitment postcode(s) [9] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Alphyn Biologics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gary Pekoe, PhD
Address 0 0
Alphyn Biologics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Dr. Lynda Spelman
Address 0 0
Country 0 0
Phone 0 0
+61730391311
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06855745