Atopic Dermatitis
Conditions
Brief summary
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis
Detailed description
This is a Phase 2 randomized, double-blind, parallel group, vehicle-controlled study to evaluate the safety and efficacy of topical ATx201 OINTMENT in adolescents and adults with mild to moderate Atopic Dermatitis. Approximately 210 subjects will be randomly assigned to receive ATx201 OINTMENT 4%, ATx201 OINTMENT 7%, or OINTMENT vehicle for 6 weeks. Treatments will be balanced into consecutive blocks in 1:1:1 ratio for the active groups and vehicle. Sixteen additional subjects (adults and adolescents) will be enrolled in a 2-week open label substudy of twice-daily ATx201 OINTMENT 7% to evaluate the PK profile of ATx201.
Interventions
DRUGATx201
Topical
DRUGATx201 OINTMENT vehicle
ATx201 OINTMENT vehicle
Sponsors
UNION therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Approx. 210 subjects randomized and 16 subjects will be in an open-label sub-study
Intervention model description
Subjects will be randomly assigned by using Interactive Web Response System (IWRS) to one of three treatment groups
Eligibility
Sex/Gender
ALL
Age
12 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
(main ones): 1. Diagnosis of AD using the Hanifin and Rajka criteria and minimum 1-year history with a current IGA score of 2 or 3 and treatable BSA ≥5% but ≤36% (treatable BSA includes all lesions present at screening except scalp) 2. Age ≥12 and \<60 years 3. Male or nonpregnant and nonlactating female who is abstinent or agrees to use effective contraceptive methods throughout the course of the study. Females must have a negative urine beta-human chorionic gonadotropin hormone (hCG) pregnancy test at Day 1. 4. Subject or LAR able to understand and provide signed informed consent. Assent is also required of adolescents. 5. Normally active and otherwise in good health by medical history and physical examination
Exclusion criteria
(main ones): 1. Actively infected AD (ie, requiring antimicrobial therapy as determined by the investigator) 2. Acute exacerbation or flare in the 4 weeks prior to the Day 1 visit that necessitates treatment with a high potency corticosteroid (such as clobetasol propionate or betamethasone dipropionate), or antibiotics, or prednisolone 3. Enrollment in an ATx201 study in the previous 6 months 4. Allergy or history of significant adverse reaction to ATx201 or related compounds, or to any of the excipients used 5. Underlying skin condition that may interfere with the placement of study treatment or impede clinical evaluations (including active Herpes simplex) 6. Current acute or chronic condition unless considered clinically irrelevant and stable by the investigator 7. The presence of a condition the investigator believes would interfere with the ability to provide informed consent or assent, or comply with study instructions, or that might confound the interpretation of the study results or put the subject at undue risk 8. Unable or unwilling to comply with study procedures 9. Exposure to any IP within 30 days prior to randomization There are also some specific criteria related to prior or concomitant therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI) | Baseline to Week 6 | EASI mean change from baseline at Week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) success | Baseline to Week 6 | IGA success with defined improvement from baseline; success defined as clear (0) or almost clear (1) with ≥2 grade improvement from baseline |
| change from baseline in Investigator Global Assessment (IGA) scoring | Baseline to Week 6 | Distribution of IGA scores and change from baseline |
| Mean change from baseline in Target lesion Total Sign Score (TSS) | Baseline to Week 6 | Target lesion TSS mean change from baseline |
Countries
Bulgaria, Denmark, Poland
Outcome results
None listed