Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TER-101
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis
Eligibility Criteria
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
Sites / Locations
- Teres Bio site 05
- Teres Bio Site 04
- Teres Bio Site 12
- Teres Bio Site 10
- Teres Bio Site 02
- Teres Bio Site 01
- Teres Bio site 09
- Teres Bio Site 08
- Teres Bio Site 11
- Teres Bio Site 03
- Teres Bio Site 06
- Teres Bio Site 07
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TER-101
Vehicle
Arm Description
BID (twice daily) application
Vehicle ointment, BID (twice daily) application
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in IGA From Baseline Over Time
IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
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".
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04753034
Brief Title
Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
May 3, 2021 (Actual)
Study Completion Date
May 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teres Bio, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TER-101
Arm Type
Experimental
Arm Description
BID (twice daily) application
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle ointment, BID (twice daily) application
Intervention Type
Drug
Intervention Name(s)
TER-101
Intervention Description
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Placebo Comparator
Primary Outcome Measure Information:
Title
Percent Change in EASI From Baseline at Day 29
Description
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 Outcome Measure Information:
Title
Changes in EASI Over Time
Description
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
Title
Change in IGA From Baseline Over Time
Description
IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
= Almost Clear
= Mild
= Moderate
= Severe
Time Frame
29 Days
Title
Changes in Itch Over Time
Description
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
Title
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Teres Bio site 05
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85255
Country
United States
Facility Name
Teres Bio Site 04
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Teres Bio Site 12
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Teres Bio Site 10
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Teres Bio Site 02
City
Clarksville
State/Province
Indiana
ZIP/Postal Code
47129
Country
United States
Facility Name
Teres Bio Site 01
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Facility Name
Teres Bio site 09
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Teres Bio Site 08
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Teres Bio Site 11
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28405
Country
United States
Facility Name
Teres Bio Site 03
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Teres Bio Site 06
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Teres Bio Site 07
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
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