Study of topical AB-101 hydrogel versus vehicle in participants with atopic dermatitis.
- Conditions
- Atopic DermatitisSkin - Dermatological conditions
- Registration Number
- ACTRN12622000395730
- Lead Sponsor
- Alphyn Biologics Australia Pty. Ltd., a subsidiary of Alphyn Biologics, LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 79
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.
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 supe
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method