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Trial registered on ANZCTR


Registration number
ACTRN12622000395730
Ethics application status
Approved
Date submitted
9/02/2022
Date registered
8/03/2022
Date last updated
11/10/2023
Date data sharing statement initially provided
8/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of topical AB-101 hydrogel versus vehicle in participants with atopic dermatitis.
Scientific title
A Phase 2, Randomized, Double-blind, Multicenter Study to Assess the Safety and Efficacy of Topical AB-101 Hydrogel Versus Vehicle in the Treatment of Participants With Mild to Moderate Atopic Dermatitis With or Without Secondary Cutaneous Infection
Secondary ID [1] 305817 0
AB-101-001-00
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atopic Dermatitis 324330 0
Condition category
Condition code
Skin 321823 321823 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The AB-101 product is a topical pharmaceutical grade Botanical Drug Product in a hydrogel carrier, derived from and containing 100% of the components of the crude plant latex (CPL) from the South American C. lechleri Müll. Arg tree. The concentration of AB101 in the finished product is 40% AB-101 in a hydrogel vehicle. The placebo contains the hydrogel vehicle only.

Participants will be randomized to receive either the active (AB-101) or placebo (hydrogel vehicle) for topical application to targeted involved atopic dermatitis. The first dose of study intervention will be administered at the study site. When participants are dosed at the site, they will receive study intervention directly from the investigator or designee, under medical supervision. The date and time of the dose applied in the clinic will be recorded in the source documents and the dosing diary. The study intervention will then be self-administered by the participants two times a day, >8 hours between applications, for up to 28 days, as this is the typical duration of treatment for atopic dermatitis. When participants self-administer study intervention at home, compliance with study intervention will be assessed at each visit. Participants will be given a diary to complete indicating the date and time of each of the 2 daily applications. Participants must bring the study intervention and diary to each study visit. Compliance will be assessed by reviewing the diary during the site visits.

All participants will be supplied with instructions on application and dose frequency. A thin layer of study intervention dispensed via a pump bottle, will be applied to each target lesion and rubbed gently in a circular motion until almost dry. The amount of product used will be depended upon lesion size and the amount of AB-101 required to cover the lesion.
Intervention code [1] 322211 0
Treatment: Drugs
Comparator / control treatment
Participants will be randomized to receive either the active (AB-101 hydrogel) or placebo (hydrogel vehicle) for topical application to targeted involved atopic dermatitis. The first dose will be applied at the clinic by the investigator or designee. The study intervention will then be self-administered by the participants, two times a day, >8 hours between applications, for up to 28 days.
Control group
Placebo

Outcomes
Primary outcome [1] 329579 0
To evaluate the safety and tolerability of AB-101 Hydrogel versus vehicle by assessing the frequency and severity of AEs & study intervention discontinuation due to AEs.
There is currently no adverse event data available for AB-101 hydrogel as this is the first time it is being given to humans.

Safety endpoints include but are not limited to the frequency and severity of TEAEs/SAEs and changes in vital signs. Adverse events will be assessed as defined by CTCAE, Version 5.0.

AEs, SAEs, and other reportable safety events will be reported by the participant (or, when
appropriate, by a caregiver, surrogate, or the participant’s legally authorized representative). The investigator and any qualified designees are responsible for detecting, documenting, and recording events that meet the definition of an AE or SAE and remain responsible for following up AE, SAEs, and other reportable safety events
Timepoint [1] 329579 0
Frequency and severity of AEs will be assessed daily from the start of treatment, day 1 to final follow-up visit on day 36.

Primary outcome [2] 330585 0
To compare the 1-point change from baseline in Investigator global assessment (IGA) score between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [2] 330585 0
Proportion of participants achieving at least a 1-point decrease in Investigator global assessment (IGA) score at Day 29 (end of treatment) or sooner.
Secondary outcome [1] 403094 0
To compare the eczema severity using the Eczema Area and Severity Index (EASI75) response between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [1] 403094 0
EASI: Percent change from baseline in eczema severity using the Eczema Area and Severity Index (EASI) total score at Day 29 (end of treatment) or sooner.
Secondary outcome [2] 406800 0
To compare the change in eczema severity using the Eczema Area and Severity Index (EASI) score between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [2] 406800 0
EASI: Percent change from baseline in eczema severity using the Eczema Area and Severity Index (EASI) total score at Day 29 (end of treatment) or sooner.
Secondary outcome [3] 406801 0
To compare the 2-point change in Investigator global assessment (IGA) score between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [3] 406801 0
Proportion of participants achieving at least a 2-point decrease in Investigator global assessment (IGA) score at Day 29 (end of treatment) or sooner
Secondary outcome [4] 406802 0
To compare the time to 1-point change in Investigator global assessment (IGA) score between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [4] 406802 0
Proportion of participants achieving at least a 1-point decrease in Investigator global assessment (IGA) score at Days 8, 15, 22, post-treatment and Day 29 (end of treatment).
Secondary outcome [5] 406803 0
To compare the time to 2-point change in Investigator global assessment (IGA) score between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [5] 406803 0
Proportion of participants achieving at least a 2-point decrease in Investigator global assessment (IGA) score at Days 8, 15, 22, post-treatment and Day 29 (end of treatment).
Secondary outcome [6] 406804 0
To compare the change in Secondary Infection Rating Scale (SIRS) between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [6] 406804 0
Secondary Infection Rating Scale (SIRS) calculated at Days 4, 8, 15, 22, post-treatment and Day 29 (end of treatment).
Secondary outcome [7] 406805 0
To compare the change in % Body Surface Area (BSA) involvement between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [7] 406805 0
Body Surface Area (BSA) calculated using rule of nines at Days 8, 15, 22, post-treatment and Day 29 (end of treatment).
Secondary outcome [8] 406806 0
To compare the change in Patient Oriented Eczema Measure (POEM) score between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2)
Timepoint [8] 406806 0
Patient Oriented Eczema Measure reported at Days 8, 15, 22, post-treatment and Day 29 (end of treatment).
Secondary outcome [9] 406807 0
To compare the change in age-specific patient-reported outcome score between treatment arms in participants with infected (Cohort 1) and non-infected AD (Cohort 2).
Outcome scores will be assessed using the following patient reported outcomes, which will be analysed together as a composite outcome:
• Dermatology Life Quality Index (DLQI)
• Children’s Dermatology Life Quality Index (CDLQI)
• Infants' Dermatitis Quality of Life Index (IDQOL)
• POEM
• Peak Pruritus NRS
Timepoint [9] 406807 0
Patient reported outcomes will be assessed every day, starting from the screening visit up until final follow up on day 36.
Secondary outcome [10] 406808 0
To compare the bacteriology response between treatment arms in participants with infected (Cohort 1).

To compare the bacteriology response, a bacteriology specimen of the infected lesion, for Gram stain, culture, and susceptibility testing will be obtained by a swab from each participant.
Timepoint [10] 406808 0
Bacteriology response at Days 4, 8, 15, 22, post-treatment and Day 29 (end of treatment).

Eligibility
Key inclusion criteria
1. Male/female participants who are 2 years of age or older on the day of providing documented informed consent/assent.
2. Have a clinical diagnosis of AD according to the criteria of Hanifin and Rajka (1980) at the Screening visit and a history of AD for at least 3 months.
3. Mild to moderate AD indicated by IGA 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 5% of total BSA at Screening and at Day 1 (Visit 1).
5. Have an EASI total score including and between 3 to 21 at Screening and at Day 1.
6. SIRS Score equal to or greater than 8 (Cohort 1) or less than 8 (Cohort 2)
7. All allowed oral and topical medications must be stable regimens within the 14 days prior to Day 1.
8. Willing to refrain from using any topical products, including cosmetics and skin cleansers to the Target Lesion, during the study intervention application period.
9. Willing to refrain from application of study intervention to areas of skin that are not within the Target Lesion.
10. Participants who are willing and able to comply with all study procedures, including scheduled visits, 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 child bearing potential (WOCBP) or a WOCBP who agrees to follow contraceptive guidance.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Medical Conditions
1. Has reliance on high-potency topical corticosteroids to manage AD signs and symptoms.
2. Has an active systemic infection requiring systemic antibiotic treatment.
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. Fitzpatrick skin phototype VI.
5. Has received prior treatment with any monoclonal antibody, TYK2 and/or JAK inhibitor.
6. Has undergone treatment 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. Hospitalization for systemic infection, chronic or acute skin infection, or use of parenteral antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals, or as otherwise judged clinically significant by the investigator.
10. Use of systemic antibiotics or systemic corticosteroids within 28 days prior to screening.
11. Use of topical antiviral agents, topical antibacterial agents, topical antifungal agents, or topical corticosteroid agents within 14 days prior to Day 1.
12. A known heritable immunodeficiency disorder.
13. Undergone significant trauma or major surgery within 3 months prior to screening.
14. Known hypersensitivity to AB-101 or any component of the hydrogel vehicle.
15. Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
16. A WOCBP who has a positive urine pregnancy test within 24 hours prior to randomization or treatment allocation. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.
Note: If 24 hours have elapsed between the screening pregnancy test and the first dose of study intervention, another pregnancy test (urine or serum) must be performed and must be negative for participant to start receiving study intervention.
17. 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.

Prior/Concurrent Clinical Study Experience
18. Is currently participating in or has participated in a study of an investigational agent or used an investigational device within 28 days prior to the first dose of study intervention.

Diagnostic Assessments
19. Has a self-reported history of HIV, Hepatitis B or Hepatitis C infection.
Note: No testing for HIV, Hepatitis C or Hepatitis C is required unless mandated by local health authority.

Other Exclusion Criteria
20. 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.
21. 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.
22. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of this study, interfere with the participant’s participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Interactive Response Technology system)
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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2022
Actual
16/05/2022
Date of last participant enrolment
Anticipated
1/10/2022
Actual
4/05/2023
Date of last data collection
Anticipated
27/07/2023
Actual
7/08/2023
Sample size
Target
72
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 21112 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [2] 21113 0
St George Dermatology & Skin Cancer Centre - Kogarah
Recruitment hospital [3] 21114 0
Veracity Clinical Research - Woolloongabba
Recruitment hospital [4] 21115 0
The Skin Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [5] 21116 0
Sinclair Dermatology - East Melbourne
Recruitment hospital [6] 21117 0
Fremantle Dermatology - Fremantle
Recruitment hospital [7] 21118 0
Captain Stirling Medical Centre - Nedlands
Recruitment postcode(s) [1] 35968 0
2010 - Sydney
Recruitment postcode(s) [2] 35969 0
2217 - Kogarah
Recruitment postcode(s) [3] 35970 0
4102 - Woolloongabba
Recruitment postcode(s) [4] 35971 0
2010 - Darlinghurst
Recruitment postcode(s) [5] 35972 0
3002 - East Melbourne
Recruitment postcode(s) [6] 35973 0
6160 - Fremantle
Recruitment postcode(s) [7] 35974 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 310164 0
Commercial sector/Industry
Name [1] 310164 0
Alphyn Biologics Australia Pty. Ltd., a subsidiary of Alphyn Biologics, LLC
Country [1] 310164 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Alphyn Biologics Australia Pty. Ltd., a subsidiary of Alphyn Biologics, LLC
Address
Alphyn Biologics Australia Pty Ltd C/O Bentleys SA
Level 5 63 Pirie Street Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 311251 0
None
Name [1] 311251 0
Address [1] 311251 0
Country [1] 311251 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309853 0
Bellberry Limited
Ethics committee address [1] 309853 0
Ethics committee country [1] 309853 0
Australia
Date submitted for ethics approval [1] 309853 0
27/10/2021
Approval date [1] 309853 0
04/02/2022
Ethics approval number [1] 309853 0

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

Contacts
Principal investigator
Name 115614 0
Dr Lynda Spelman
Address 115614 0
Veracity Clinical Research
Suite 18, Level 1, 250 Ipswich Road,
Woolloongabba QLD 4102
Country 115614 0
Australia
Phone 115614 0
+61 730391311
Fax 115614 0
Email 115614 0
spelchat@veracity.net.au
Contact person for public queries
Name 115615 0
Greg Plunkett
Address 115615 0
Accelagen Pty Ltd
Suite 1.02, Level 1
722 High Street, Kew East
Victoria, Australia 3102
Country 115615 0
Australia
Phone 115615 0
+61 3 9114 2274
Fax 115615 0
+61 3 8845 0200
Email 115615 0
greg.plunkett@accelagen.com.au
Contact person for scientific queries
Name 115616 0
Lynda Spelman
Address 115616 0
Veracity Clinical Research
Suite 18, Level 1, 250 Ipswich Road,
Woolloongabba QLD 4102
Country 115616 0
Australia
Phone 115616 0
+61 730391311
Fax 115616 0
Email 115616 0
spelchat@veracity.net.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The Sponsor, Alphyn Biologics Australia Pty. Ltd., will not be sharing data with anyone outside of Alphyn and the CRO involved in the study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.