A Multicenter, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of TER-101 Topical Ointment to Assess Efficacy and Safety in Subjects With Mild to Moderate Atopic
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Teres Bio, Inc.
- Enrollment
- 63
- Locations
- 12
- Primary Endpoint
- Percent Change in EASI From Baseline at Day 29
Study Overview
Brief Summary
This Phase 2 study will assess efficacy, safety, and tolerability of TER-101 ointment and vehicle twice daily for 28 days in adult and adolescent subjects with mild to moderate atopic dermatitis.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adolescent or adult subject aged 12 - 65 years.
- •Overall IGA score of 2 (mild) or 3 (moderate) at baseline on a 5-point IGA
Exclusion Criteria
- •AD with known hypersensitivity to excipients of TER-101 Ointment
- •Subjects who are immunocompromised
Arms & Interventions
TER-101
BID (twice daily) application
Intervention: TER-101 (Drug)
Vehicle
Vehicle ointment, BID (twice daily) application
Intervention: Vehicle (Drug)
Outcomes
Primary Outcomes
Percent Change in EASI From Baseline at Day 29
Time Frame: 29 days
EASI = Eczema Area and Severity Index, EASI combines the assessment of the severity of lesions and the the numerical area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for erythema, induration, lichenification, excoriation are multiplied with value of the area affected and with the percentage of the four body areas.
Secondary Outcomes
- Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD(29 days)
- Changes in EASI Over Time(15 days)
- Change in IGA From Baseline Over Time(29 Days)
- Changes in Itch Over Time(29 days)