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Completed

NCT Number: NCT04753034

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Teres Bio site 05, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TER-101

Drug

Active Comparator

Vehicle

Drug

Placebo Comparator

Primary outcomes

  1. Percent Change in EASI From Baseline at Day 29

    Time frame: 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 outcomes

  1. Changes in EASI Over Time

    Time frame: 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.

  2. Change in IGA From Baseline Over Time

    Time frame: 29 Days

    IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear

    • = Almost Clear
    • = Mild
    • = Moderate
    • = Severe

  3. Changes in Itch Over Time

    Time frame: 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".

  4. Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Teres Bio, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2021
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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