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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04753034
Other study ID # TER101-AD-201
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 18, 2021
Est. completion date May 3, 2021

Study information

Verified date February 2021
Source Teres Bio, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 63
Est. completion date May 3, 2021
Est. primary completion date May 3, 2021
Accepts healthy volunteers No
Gender All
Age group 12 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
TER-101
Active Comparator
Vehicle
Placebo Comparator

Locations

Country Name City State
United States Teres Bio Site 02 Clarksville Indiana
United States Teres Bio Site 03 College Station Texas
United States Teres Bio Site 04 Encinitas California
United States Teres Bio Site 08 High Point North Carolina
United States Teres Bio Site 01 Louisville Kentucky
United States Teres Bio Site 12 North Miami Beach Florida
United States Teres Bio Site 06 Pflugerville Texas
United States Teres Bio site 09 Saint Joseph Missouri
United States Teres Bio Site 07 San Antonio Texas
United States Teres Bio site 05 Scottsdale Arizona
United States Teres Bio Site 10 Tampa Florida
United States Teres Bio Site 11 Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Teres Bio, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary Change in IGA From Baseline Over Time IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
29 Days
Secondary 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
Secondary 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
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