None listed
Conditions
Brief summary
Atopic dermatitis is a common chronic disorder of the skin that occurs mostly in infants and children. In some cases, this disorder may resolve by itself, however it is common for atopic dermatitis to continue until adolescence and adulthood, where this disorder can exist together with respiratory allergies such as asthma or allergic rhinitis (hay fever). AB-101 Hydrogel contains Crude Plant Latex, which has antibacterial (destroys bacteria or stops its growth), anti-inflammatory (reduces redness, swelling and pain), and anti-pruritic (anti-itching) properties. AB-101 is designed to be used as a single treatment for atopic dermatitis, that can be applied to the skin. The purpose of this study is to gain more information on whether AB-101 Hydrogel works and is safe for the treatment of mild to moderate atopic dermatitis, with or without infection. To test this, the safety and efficacy of AB-101 will be compared to its hydrogel vehicle in participants with mild to moderate AD with or without secondary infection. It is hypothesized that AB-101 Hydrogel is superior to hydrogel vehicle alone.
Interventions
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 ta
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.
Sponsors
Alphyn Biologics Australia Pty. Ltd., a subsidiary of Alphyn Biologics, LLC
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed