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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

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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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Atopic Dermatitis
Interventions Drug: TER-101
Drug: Vehicle
Enrollment 63
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TER-101 Vehicle
Hide Arm/Group Description

BID (twice daily) application

TER-101: Active Comparator

Vehicle ointment, BID (twice daily) application

Vehicle: Placebo Comparator

Period Title: Overall Study
Started 31 32
Completed 29 31
Not Completed 2 1
Arm/Group Title TER-101 Vehicle Total
Hide Arm/Group Description

BID (twice daily) application

TER-101: Active Comparator

Vehicle ointment, BID (twice daily) application

Vehicle: Placebo Comparator

Total of all reporting groups
Overall Number of Baseline Participants 31 32 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
<=18 years
7
  22.6%
3
   9.4%
10
  15.9%
Between 18 and 65 years
24
  77.4%
29
  90.6%
53
  84.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Female
24
  77.4%
21
  65.6%
45
  71.4%
Male
7
  22.6%
11
  34.4%
18
  28.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
Hispanic or Latino
2
   6.5%
2
   6.3%
4
   6.3%
Not Hispanic or Latino
27
  87.1%
29
  90.6%
56
  88.9%
Unknown or Not Reported
2
   6.5%
1
   3.1%
3
   4.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 31 participants 32 participants 63 participants
White
21
  67.7%
15
  46.9%
36
  57.1%
Asian
5
  16.1%
2
   6.3%
7
  11.1%
Black or African American
4
  12.9%
13
  40.6%
17
  27.0%
Other
0
   0.0%
1
   3.1%
1
   1.6%
More than one race
1
   3.2%
1
   3.1%
2
   3.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 32 participants 63 participants
31 32 63
EASI  
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 31 participants 32 participants 63 participants
7.97  (2.424) 8.47  (3.016) 8.22  (2.730)
Overall IGA score  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 63 participants
2 - mild
8
  25.8%
7
  21.9%
15
  23.8%
3 - moderate
23
  74.2%
25
  78.1%
48
  76.2%
WI-NRS  
Mean (Standard Deviation)
Unit of measure:  Scores on a scale
Number Analyzed 31 participants 32 participants 63 participants
5.1  (2.14) 5.5  (2.58) 5.3  (2.37)
Total body surface area  
Mean (Standard Deviation)
Unit of measure:  Percent of body surface area
Number Analyzed 31 participants 32 participants 63 participants
7.2  (3.58) 7.8  (3.83) 7.5  (3.69)
1.Primary Outcome
Title Percent Change in EASI From Baseline at Day 29
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 application of the study treatment and had at least 1 post-baseline efficacy assessment. The treatment group as assigned (randomized) was used for analyses.
Arm/Group Title TER-101 Vehicle
Hide Arm/Group Description:

BID (twice daily) application

TER-101: Active Comparator

Vehicle ointment, BID (twice daily) application

Vehicle: Placebo Comparator

Overall Number of Participants Analyzed 31 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent change
-47.37
(-67.088 to -27.653)
-42.10
(-61.476 to -22.721)
2.Secondary Outcome
Title Changes in EASI Over Time
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 application of the study treatment and had at least 1 post-baseline efficacy assessment. The treatment group as assigned (randomized) was used for analyses.
Arm/Group Title TER-101 Vehicle
Hide Arm/Group Description:

BID (twice daily) application

TER-101: Active Comparator

Vehicle ointment, BID (twice daily) application

Vehicle: Placebo Comparator

Overall Number of Participants Analyzed 31 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: percent
-35.96
(-51.842 to -20.081)
-39.24
(-54.739 to -23.742)
3.Secondary Outcome
Title Change in IGA From Baseline Over Time
Hide Description

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

  1. = Almost Clear
  2. = Mild
  3. = Moderate
  4. = Severe
Time Frame 29 Days
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 application of the study treatment and had at least 1 post-baseline efficacy assessment. The treatment group as assigned (randomized) was used for analyses.
Arm/Group Title TER-101 Vehicle
Hide Arm/Group Description:

BID (twice daily) application

TER-101: Active Comparator

Vehicle ointment, BID (twice daily) application

Vehicle: Placebo Comparator

Overall Number of Participants Analyzed 31 32
Mean (Full Range)
Unit of Measure: score on a scale
-0.7
(-3 to 1)
-0.7
(-3 to 0)
4.Secondary Outcome
Title Changes in Itch Over Time
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 application of the study treatment and had at least 1 post-baseline efficacy assessment. The treatment group as assigned (randomized) was used for analyses.
Arm/Group Title TER-101 Vehicle
Hide Arm/Group Description:

BID (twice daily) application

TER-101: Active Comparator

Vehicle ointment, BID (twice daily) application

Vehicle: Placebo Comparator

Overall Number of Participants Analyzed 31 32
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
-2.0
(-2.92 to -1.14)
-1.2
(-2.00 to -0.32)
5.Secondary Outcome
Title Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 application of the study treatment. The treatment group for analyses was determined by the treatment received. If any TER-101 was applied, the participant was summarized under the TER-101 treatment group.
Arm/Group Title TER-101 Vehicle
Hide Arm/Group Description:

BID (twice daily) application

TER-101: Active Comparator

Vehicle ointment, BID (twice daily) application

Vehicle: Placebo Comparator

Overall Number of Participants Analyzed 31 32
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline Erythema - none
17
  54.8%
15
  46.9%
Baseline Erythema - mild
0
   0.0%
2
   6.3%
Baseline Erythema - moderate
1
   3.2%
2
   6.3%
Baseline Erythema - Severe
0
   0.0%
0
   0.0%
Day 29 Erythema - none
15
  48.4%
14
  43.8%
Day 29 Erythema -mild
2
   6.5%
5
  15.6%
Day 29 Erythema - moderate
7
  22.6%
7
  21.9%
Day 29 Erythema - severe
0
   0.0%
0
   0.0%
Burning/Stinging baseline - none
22
  71.0%
26
  81.3%
Burning/Stinging baseline - mild
3
   9.7%
3
   9.4%
Burning/Stinging baseline - moderate
1
   3.2%
1
   3.1%
Burning/Stinging baseline - severe
0
   0.0%
0
   0.0%
Burning/Stinging D29 - none
20
  64.5%
24
  75.0%
Burning/Stinging D29 - mild
0
   0.0%
3
   9.4%
Burning/Stinging D29 - moderate
1
   3.2%
2
   6.3%
Burning/Stinging D29 - severe
1
   3.2%
0
   0.0%
Pruritis - Baseline - none
14
  45.2%
18
  56.3%
Pruritis - Baseline - mild
6
  19.4%
3
   9.4%
Pruritis - Baseline - moderate
2
   6.5%
2
   6.3%
Pruritis - Baseline - severe
1
   3.2%
0
   0.0%
Pruritis - D29 - none
13
  41.9%
15
  46.9%
Pruritis - D29 - mild
7
  22.6%
3
   9.4%
Pruritis - D29 - moderate
6
  19.4%
10
  31.3%
Pruritis - D29 - severe
0
   0.0%
0
   0.0%
Time Frame 29 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TER-101 Vehicle
Hide Arm/Group Description

BID (twice daily) application

TER-101: Active Comparator

Vehicle ointment, BID (twice daily) application

Vehicle: Placebo Comparator

All-Cause Mortality
TER-101 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/32 (0.00%) 
Hide Serious Adverse Events
TER-101 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   1/31 (3.23%)   0/32 (0.00%) 
Infections and infestations     
Kidney infection * 1  1/31 (3.23%)  0/32 (0.00%) 
Pneumonia * 1  1/31 (3.23%)  0/32 (0.00%) 
Urinary tract infection * 1  1/31 (3.23%)  0/32 (0.00%) 
1
Term from vocabulary, MedDRA version 24.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TER-101 Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   9/31 (29.03%)   3/32 (9.38%) 
Cardiac disorders     
Bundle branch block right * 1  1/31 (3.23%)  0/32 (0.00%) 
Eye disorders     
Eye irritation * 1  1/31 (3.23%)  0/32 (0.00%) 
Gastrointestinal disorders     
Diarrhoea * 1  1/31 (3.23%)  0/32 (0.00%) 
General disorders     
Application site pain * 1  1/31 (3.23%)  1/32 (3.13%) 
Product intolerance * 1  1/31 (3.23%)  0/32 (0.00%) 
Application site inflammation * 1  0/31 (0.00%)  1/32 (3.13%) 
Hangover * 1  0/31 (0.00%)  1/32 (3.13%) 
Infections and infestations     
Pilonidal cyst * 1  1/31 (3.23%)  0/32 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/31 (3.23%)  0/32 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Sinus congestion * 1  1/31 (3.23%)  0/32 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis atopic * 1  1/31 (3.23%)  0/32 (0.00%) 
Seborrhoeic dermatitis * 1  1/31 (3.23%)  0/32 (0.00%) 
Skin hypopigmentation * 1  1/31 (3.23%)  0/32 (0.00%) 
Urticaria * 1  1/31 (3.23%)  0/32 (0.00%) 
1
Term from vocabulary, MedDRA version 24.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
After database lock, Institution/Investigator may publish trial data generated by Investigator at Institution upon the earlier of: (i) publication of primary Multicenter Publication; or (ii) 18 months after the Trial is completed, if a Multicenter Publication is not submitted by Sponsor for publication within such 18 month period; provided Sponsor has opportunity to review proposed publication or disclosure at least 60 days in advance of its submission to a journal, congress, panel, etc.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: VP, Clinical Operations
Organization: Aditum Bio
Phone: (510) 227-2102
EMail: Chris.resburg@aditumbio.com
Layout table for additonal information
Responsible Party: Teres Bio, Inc.
ClinicalTrials.gov Identifier: NCT04753034    
Other Study ID Numbers: TER101-AD-201
First Submitted: January 21, 2021
First Posted: February 12, 2021
Results First Submitted: April 28, 2022
Results First Posted: July 19, 2022
Last Update Posted: July 26, 2022