Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: TER-101
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TER-101<br>BID (twice daily) application | Drug: TER-101<br>* Active Comparator<br>|
| Placebo Comparator: Vehicle<br>Vehicle ointment, BID (twice daily) application | Drug: Vehicle<br>* Placebo Comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in EASI From Baseline at Day 29 | 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. | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in EASI Over Time | EASI combines the assessment of the severity of lesions and the 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 the numerical value of the area affected and with the percentage of the four body areas. | 15 days | 
| Change in IGA From Baseline Over Time | IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear = Almost Clear = Mild = Moderate = Severe | 29 Days | 
| Changes in Itch Over Time | The WI-NRS asks subjects to report their worst itch (maximal intensity) during the last 24 hours on an 11-point NRS, ranging from 0 = no itch at all to 10 = worst itch you can imagine. | 29 days | 
| Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Sum of erythema, itch, and burning at the time of visit compared to baseline measured on a 0 - 3 scale for each component. A score of 0 indicates no erythema, itch or burning. Higher scores indicate worsening tolerability: 1 (mild), 2 (moderate), 3 (severe) | 29 days |