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

Teres Bio, Inc.63 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

TER-101DRUG

Active Comparator

VehicleDRUG

Placebo Comparator

Eligibility

Sex: ALLMin age: 12 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (12)

Teres Bio site 05

Scottsdale, Arizona, United States

Teres Bio Site 04

Encinitas, California, United States

Teres Bio Site 12

North Miami Beach, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 29 days

Secondary Outcomes

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.

Time frame: 15 days

Change in IGA From Baseline Over Time

IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe

Time frame: 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".

Time frame: 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)

Time frame: 29 days

Data from ClinicalTrials.gov

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