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

Phase 2

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: TER-101; Drug: Vehicle

• Registration Number: NCT04753034
• Lead Sponsor: Teres Bio, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-18
• Study First Submitted: 2021-01-21
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-12
• Primary Completion: 2021-05-03
• Study Completion: 2021-05-03
• Results First Submitted: 2022-04-28
• Results First Submitted QC: 2022-06-23
• Results First Posted: 2022-07-19
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TER-101	TER-101	BID (twice daily) application
Vehicle	Vehicle	Vehicle ointment, BID (twice daily) application

Primary Outcome Measures

Name	Time	Method
Percent Change in EASI From Baseline at Day 29	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 Outcome Measures

Name	Time	Method
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD	29 days	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)
Changes in EASI Over Time	15 days	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.
Change in IGA From Baseline Over Time	29 Days	IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear; 1. = Almost Clear; 2. = Mild; 3. = Moderate; 4. = Severe
Changes in Itch Over Time	29 days	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".

Trial Locations

Locations (12)

Teres Bio Site 06; 🇺🇸 Pflugerville, Texas, United States

Teres Bio Site 11; 🇺🇸 Wilmington, North Carolina, United States

Teres Bio site 09; 🇺🇸 Saint Joseph, Missouri, United States

Teres Bio Site 07; 🇺🇸 San Antonio, Texas, United States

Teres Bio Site 02; 🇺🇸 Clarksville, Indiana, United States

Teres Bio Site 04; 🇺🇸 Encinitas, California, United States

Teres Bio Site 12; 🇺🇸 North Miami Beach, Florida, United States

Teres Bio Site 10; 🇺🇸 Tampa, Florida, United States

Teres Bio Site 01; 🇺🇸 Louisville, Kentucky, United States

Teres Bio Site 08; 🇺🇸 High Point, North Carolina, United States

Teres Bio site 05; 🇺🇸 Scottsdale, Arizona, United States

Teres Bio Site 03; 🇺🇸 College Station, Texas, United States