Study of TER-101 Topical Ointment in Subjects With Atopic Dermatitis
Sponsor
Teres Bio, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04753034
Collaborator
(none)
63
12
2
3.4
5.3
1.5
Study Details
Study Description
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 |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
63 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
:
Jan 18, 2021
Actual Primary Completion Date
:
May 3, 2021
Actual Study Completion Date
:
May 3, 2021
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Percent Change in EASI From Baseline at Day 29 [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 Outcome Measures
- Changes in EASI Over Time [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 [29 Days]
IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear = Almost Clear = Mild = Moderate = Severe
- Changes in Itch Over Time [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 [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)
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Teres Bio site 05 | Scottsdale | Arizona | United States | 85255 |
| 2 | Teres Bio Site 04 | Encinitas | California | United States | 92024 |
| 3 | Teres Bio Site 12 | North Miami Beach | Florida | United States | 33162 |
| 4 | Teres Bio Site 10 | Tampa | Florida | United States | 33613 |
| 5 | Teres Bio Site 02 | Clarksville | Indiana | United States | 47129 |
| 6 | Teres Bio Site 01 | Louisville | Kentucky | United States | 40241 |
| 7 | Teres Bio site 09 | Saint Joseph | Missouri | United States | 64506 |
| 8 | Teres Bio Site 08 | High Point | North Carolina | United States | 27262 |
| 9 | Teres Bio Site 11 | Wilmington | North Carolina | United States | 28405 |
| 10 | Teres Bio Site 03 | College Station | Texas | United States | 77845 |
| 11 | Teres Bio Site 06 | Pflugerville | Texas | United States | 78660 |
| 12 | Teres Bio Site 07 | San Antonio | Texas | United States | 78229 |
Sponsors and Collaborators
- Teres Bio, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Teres Bio, Inc.
ClinicalTrials.gov Identifier:
NCT04753034
Other Study ID Numbers:
- TER101-AD-201
First Posted:
Feb 12, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TER-101 | Vehicle |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | TER-101 | Vehicle | Total |
|---|---|---|---|
| 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 Participants | 31 | 32 | 63 |
| Age (Count of 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%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
77.4%
|
21
65.6%
|
45
71.4%
|
| Male |
7
22.6%
|
11
34.4%
|
18
28.6%
|
| Ethnicity (NIH/OMB) (Count of 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 (Count of 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%
|
| Other |
0
0%
|
1
3.1%
|
1
1.6%
|
| More than one race |
1
3.2%
|
1
3.1%
|
2
3.2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
31
100%
|
32
100%
|
63
100%
|
| EASI (Scores on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Scores on a scale] |
7.97
(2.424)
|
8.47
(3.016)
|
8.22
(2.730)
|
| Overall IGA score (Count of 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 (scores on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [scores on a scale] |
5.1
(2.14)
|
5.5
(2.58)
|
5.3
(2.37)
|
| Total body surface area (Percent of body surface area) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Percent of body surface area] |
7.2
(3.58)
|
7.8
(3.83)
|
7.5
(3.69)
|
Outcome Measures
| Title | Percent Change in EASI From Baseline at Day 29 |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | BID (twice daily) application TER-101: Active Comparator | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator |
| Measure Participants | 31 | 32 |
| Least Squares Mean (95% Confidence Interval) [percent change] |
-47.37
|
-42.10
|
| Title | Changes in EASI Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | BID (twice daily) application TER-101: Active Comparator | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator |
| Measure Participants | 31 | 32 |
| Least Squares Mean (95% Confidence Interval) [percent] |
-35.96
|
-39.24
|
| Title | Change in IGA From Baseline Over Time |
|---|---|
| Description | IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear = Almost Clear = Mild = Moderate = Severe |
| Time Frame | 29 Days |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | BID (twice daily) application TER-101: Active Comparator | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator |
| Measure Participants | 31 | 32 |
| Mean (Full Range) [score on a scale] |
-0.7
|
-0.7
|
| Title | Changes in Itch Over Time |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | BID (twice daily) application TER-101: Active Comparator | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator |
| Measure Participants | 31 | 32 |
| Least Squares Mean (95% Confidence Interval) [score on a scale] |
-2.0
|
-1.2
|
| Title | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|
| Arm/Group Description | BID (twice daily) application TER-101: Active Comparator | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator |
| Measure Participants | 31 | 32 |
| Baseline Erythema - none |
17
54.8%
|
15
46.9%
|
| Baseline Erythema - mild |
0
0%
|
2
6.3%
|
| Baseline Erythema - moderate |
1
3.2%
|
2
6.3%
|
| Baseline Erythema - Severe |
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%
|
| Burning/Stinging baseline - none |
22
71%
|
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%
|
| Burning/Stinging D29 - none |
20
64.5%
|
24
75%
|
| Burning/Stinging D29 - mild |
0
0%
|
3
9.4%
|
| Burning/Stinging D29 - moderate |
1
3.2%
|
2
6.3%
|
| Burning/Stinging D29 - severe |
1
3.2%
|
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%
|
| 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%
|
Adverse Events
| Time Frame | 29 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | TER-101 | Vehicle | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/31 (0%) | 0/32 (0%) | ||
Serious Adverse Events |
||||
| TER-101 | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/31 (3.2%) | 0/32 (0%) | ||
| Infections and infestations | ||||
| Kidney infection | 1/31 (3.2%) | 0/32 (0%) | ||
| Pneumonia | 1/31 (3.2%) | 0/32 (0%) | ||
| Urinary tract infection | 1/31 (3.2%) | 0/32 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| TER-101 | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/31 (29%) | 3/32 (9.4%) | ||
| Cardiac disorders | ||||
| Bundle branch block right | 1/31 (3.2%) | 0/32 (0%) | ||
| Eye disorders | ||||
| Eye irritation | 1/31 (3.2%) | 0/32 (0%) | ||
| Gastrointestinal disorders | ||||
| Diarrhoea | 1/31 (3.2%) | 0/32 (0%) | ||
| General disorders | ||||
| Application site pain | 1/31 (3.2%) | 1/32 (3.1%) | ||
| Product intolerance | 1/31 (3.2%) | 0/32 (0%) | ||
| Application site inflammation | 0/31 (0%) | 1/32 (3.1%) | ||
| Hangover | 0/31 (0%) | 1/32 (3.1%) | ||
| Infections and infestations | ||||
| Pilonidal cyst | 1/31 (3.2%) | 0/32 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain | 1/31 (3.2%) | 0/32 (0%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Sinus congestion | 1/31 (3.2%) | 0/32 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Dermatitis atopic | 1/31 (3.2%) | 0/32 (0%) | ||
| Seborrhoeic dermatitis | 1/31 (3.2%) | 0/32 (0%) | ||
| Skin hypopigmentation | 1/31 (3.2%) | 0/32 (0%) | ||
| Urticaria | 1/31 (3.2%) | 0/32 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | VP, Clinical Operations |
|---|---|
| Organization | Aditum Bio |
| Phone | (510) 227-2102 |
| Chris.resburg@aditumbio.com |
Responsible Party:
Teres Bio, Inc.
ClinicalTrials.gov Identifier:
NCT04753034
Other Study ID Numbers:
- TER101-AD-201
First Posted:
Feb 12, 2021
Last Update Posted:
Jul 26, 2022
Last Verified:
Feb 1, 2021