A Randomized, Double-Blind, Parallel Group, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Topical ATx201 OINTMENT in Adolescents and Adults With Mild to Moderate Atopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- ATx201
- Conditions
- Atopic Dermatitis
- Sponsor
- UNION therapeutics
- Enrollment
- 220
- Locations
- 10
- Primary Endpoint
- Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ATx201 OINTMENT 4%
ATx201 OINTMENT 4%
Intervention: ATx201
ATx201 OINTMENT 7%
ATx201 OINTMENT 7%
Intervention: ATx201
ATx201 OINTMENT vehicle
ATx201 OINTMENT vehicle
Intervention: ATx201 OINTMENT vehicle
Outcomes
Primary Outcomes
Mean change from baseline at Week 6 in Eczema Area Severity Index (EASI)
Time Frame: Baseline to Week 6
EASI mean change from baseline at Week 6
Secondary Outcomes
- Investigator Global Assessment (IGA) success(Baseline to Week 6)
- Mean change from baseline in Target lesion Total Sign Score (TSS)(Baseline to Week 6)
- change from baseline in Investigator Global Assessment (IGA) scoring(Baseline to Week 6)