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

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

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 Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Vehicle; Drug: TER-101

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Teres Bio site 05
  • California
    • Encinitas, California, United States, 92024
      • Teres Bio Site 04
  • Florida
    • North Miami Beach, Florida, United States, 33162
      • Teres Bio Site 12
    • Tampa, Florida, United States, 33613
      • Teres Bio Site 10
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • Teres Bio Site 02
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Teres Bio Site 01
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Teres Bio site 09
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Teres Bio Site 08
    • Wilmington, North Carolina, United States, 28405
      • Teres Bio Site 11
  • Texas
    • College Station, Texas, United States, 77845
      • Teres Bio Site 03
    • Pflugerville, Texas, United States, 78660
      • Teres Bio Site 06
    • San Antonio, Texas, United States, 78229
      • Teres Bio Site 07

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TER-101; BID (twice daily) application	Drug: TER-101; Active Comparator
PLACEBO_COMPARATOR: Vehicle; Vehicle ointment, BID (twice daily) application	Drug: Vehicle; Placebo Comparator

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Teres Bio, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2021
• Primary Completion (ACTUAL): May 3, 2021
• Study Completion (ACTUAL): May 3, 2021

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (ACTUAL): February 12, 2021

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: TER101-AD-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No