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

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ClinicalTrials.gov Identifier: NCT04753034
Recruitment Status : Active, not recruiting
First Posted : February 12, 2021
Last Update Posted : March 22, 2021
Sponsor:
Information provided by (Responsible Party):
Teres Bio, Inc.

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: TER-101 Drug: Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 18, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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".

  4. 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.

  5. Safety - Adverse Events (AEs) [ Time Frame: 30 days ]
    Comparison by treatment group of reported adverse events (MedRA coded).



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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04753034


Locations
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United States, Arizona
Teres Bio site 05
Scottsdale, Arizona, United States, 85255
United States, California
Teres Bio Site 04
Encinitas, California, United States, 92024
United States, Florida
Teres Bio Site 12
North Miami Beach, Florida, United States, 33162
Teres Bio Site 10
Tampa, Florida, United States, 33613
United States, Indiana
Teres Bio Site 02
Clarksville, Indiana, United States, 47129
United States, Kentucky
Teres Bio Site 01
Louisville, Kentucky, United States, 40241
United States, Missouri
Teres Bio site 09
Saint Joseph, Missouri, United States, 64506
United States, North Carolina
Teres Bio Site 08
High Point, North Carolina, United States, 27262
Teres Bio Site 11
Wilmington, North Carolina, United States, 28405
United States, Texas
Teres Bio Site 03
College Station, Texas, United States, 77845
Teres Bio Site 06
Pflugerville, Texas, United States, 78660
Teres Bio Site 07
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Teres Bio, Inc.
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Responsible Party: Teres Bio, Inc.
ClinicalTrials.gov Identifier: NCT04753034    
Other Study ID Numbers: TER101-AD-201
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: March 22, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases