Atopic Dermatitis MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Interventions
Product Name: ATx201 OINTMENT
Product Code: ATx201
Pharmaceutical Form: Ointment
INN or Proposed INN: Niclosamide
CAS Number: 50-65-7
Current Sponsor code: ATx201
Other descriptive name: NICLOSAMIDE
C
Sponsors
UNION therapeutics A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 niclosamide 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 Prior or concomitant therapy 10. Systemic anti-inflammatory/immunomodulatory/immunosuppressant drugs, systemic antihistamine regimens, systemic antimycotic treatments, or topical high-potency corticosteroids 4 weeks prior to Day 1 (subjects requiring chronic antihistamine therapy that have been stable on treatment for more than 3 months are allowed to participate in the study) 11. Ultraviolet phototherapy or use of tanning booths within 4 weeks prior to Day 1, or is not willing to minimize natural and artificial sunlight exposure during the study 12. Topical medium-potency corticosteroids, topical calcineurin or PDE4 inhibitors, topical retinoids, topical antimycotic treatments, oral antibiotics for infected AD, or bleach baths within 2 weeks prior to Day 1 13. Topical low-potency corticosteroids, topical antihistamines, or topical antibacterial medications within 1 week prior to Day 1 14. Use of emollients on the target lesion within 4 hours of the first application
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate clinical efficacy of ATx201 in subjects with mild to moderate AD.;Secondary Objective: Confirm safety and tolerability of ATx201 in subjects with mild to moderate AD;Primary end point(s): EASI mean change from baseline at Week 6;Timepoint(s) of evaluation of this end point: Week 6. Data from visits at Weeks 1, 2 and 4 will also be analyzed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - EASI-50 and EASI-75 - IGA success defined as clear (0) or almost clear (1) with =2grade improvement from baseline - Distribution of IGA scores (full scale/all categories) and of its change from baseline - Proportion of subjects with a treatable BSA<5% - TSS mean change from baseline;Timepoint(s) of evaluation of this end point: Week 6. Data from visits before Week 6 will also be analyzed. | — |
Countries
Bulgaria, Denmark, Poland
Contacts
Public ContactRegulatory Affairs Department
Nordic Bioscience Clinical Development
Outcome results
None listed