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Trial record 1 of 1 for:    TER-101
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Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04753034
Recruitment Status : Completed
First Posted : February 12, 2021
Results First Posted : July 19, 2022
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Teres Bio, Inc.

Tracking Information
First Submitted Date  ICMJE January 21, 2021
First Posted Date  ICMJE February 12, 2021
Results First Submitted Date  ICMJE April 28, 2022
Results First Posted Date  ICMJE July 19, 2022
Last Update Posted Date July 26, 2022
Actual Study Start Date  ICMJE January 18, 2021
Actual Primary Completion Date May 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 26, 2022)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2021)
Percent change in EASI from baseline at Day 29 [ Time Frame: 30 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, lichenifcation, excoriation are multiplied with value of the area affected and with the percentage of the four body areas.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2022)
  • 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.
  • Change in IGA From Baseline Over Time [ Time Frame: 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 [ 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".
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2021)
  • Changes in EASI over time [ Time Frame: 15 - 30 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, lichenifcation, 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 [ Time Frame: 15 - 30 days ]
    IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
    1. = Almost Clear
    2. = Mild
    3. = Moderate
    4. = Severe
  • Changes in itch over time [ Time Frame: 15 - 30 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".
  • Tolerability of TER-101 ointment vs. vehicle in subjects with AD [ Time Frame: 30 days ]
    Sum of erythema, itch, and burning at the time of visit compared to baseline measured on a 0 - 3 scale for each component.
  • Safety - Adverse Events (AEs) [ Time Frame: 30 days ]
    Comparison by treatment group of reported adverse events (MedRA coded).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Drug: TER-101
    Active Comparator
  • Drug: Vehicle
    Placebo Comparator
Study Arms  ICMJE
  • Experimental: TER-101
    BID (twice daily) application
    Intervention: Drug: TER-101
  • Placebo Comparator: Vehicle
    Vehicle ointment, BID (twice daily) application
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2021)
63
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2021)
60
Actual Study Completion Date  ICMJE May 3, 2021
Actual Primary Completion Date May 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04753034
Other Study ID Numbers  ICMJE TER101-AD-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Teres Bio, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Teres Bio, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Teres Bio, Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP