Atopic Dermatitis
Conditions
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.
Interventions
DRUGTER-101
Active Comparator
DRUGVehicle
Placebo Comparator
Sponsors
Teres Bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 1. = Almost Clear 2. = Mild 3. = Moderate 4. = 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TER-101 BID (twice daily) application
TER-101: Active Comparator | 31 |
| Vehicle Vehicle ointment, BID (twice daily) application
Vehicle: Placebo Comparator | 32 |
| Total | 63 |
Baseline characteristics
| Characteristic | Total | TER-101 | Vehicle |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 7 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants | 24 Participants | 29 Participants |
| EASI | 8.22 Scores on a scale STANDARD_DEVIATION 2.73 | 7.97 Scores on a scale STANDARD_DEVIATION 2.424 | 8.47 Scores on a scale STANDARD_DEVIATION 3.016 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 27 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| Overall IGA score 2 - mild | 15 Participants | 8 Participants | 7 Participants |
| Overall IGA score 3 - moderate | 48 Participants | 23 Participants | 25 Participants |
| Race/Ethnicity, Customized Race Asian | 7 Participants | 5 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black or African American | 17 Participants | 4 Participants | 13 Participants |
| Race/Ethnicity, Customized Race More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 36 Participants | 21 Participants | 15 Participants |
| Region of Enrollment United States | 63 participants | 31 participants | 32 participants |
| Sex: Female, Male Female | 45 Participants | 24 Participants | 21 Participants |
| Sex: Female, Male Male | 18 Participants | 7 Participants | 11 Participants |
| Total body surface area | 7.5 Percent of body surface area STANDARD_DEVIATION 3.69 | 7.2 Percent of body surface area STANDARD_DEVIATION 3.58 | 7.8 Percent of body surface area STANDARD_DEVIATION 3.83 |
| WI-NRS | 5.3 scores on a scale STANDARD_DEVIATION 2.37 | 5.1 scores on a scale STANDARD_DEVIATION 2.14 | 5.5 scores on a scale STANDARD_DEVIATION 2.58 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 9 / 31 | 3 / 32 |
| serious Total, serious adverse events | 1 / 31 | 0 / 32 |
Outcome results
Primary
Percent Change in EASI From Baseline at Day 29
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| TER-101 | Percent Change in EASI From Baseline at Day 29 | -47.37 percent change |
| Vehicle | Percent Change in EASI From Baseline at Day 29 | -42.10 percent change |
Secondary
Change in IGA From Baseline Over Time
IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear 1. = Almost Clear 2. = Mild 3. = Moderate 4. = Severe
Time frame: 29 Days
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| TER-101 | Change in IGA From Baseline Over Time | -0.7 score on a scale |
| Vehicle | Change in IGA From Baseline Over Time | -0.7 score on a scale |
Secondary
Changes in EASI Over Time
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| TER-101 | Changes in EASI Over Time | -35.96 percent |
| Vehicle | Changes in EASI Over Time | -39.24 percent |
Secondary
Changes in Itch Over Time
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
Population: 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 | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| TER-101 | Changes in Itch Over Time | -2.0 score on a scale |
| Vehicle | Changes in Itch Over Time | -1.2 score on a scale |
Secondary
Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD
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
Population: 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 | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging baseline - severe | 0 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Day 29 Erythema -mild | 2 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging D29 - none | 20 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Baseline Erythema - moderate | 1 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging D29 - mild | 0 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Day 29 Erythema - moderate | 7 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging D29 - moderate | 1 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Baseline Erythema - none | 17 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging D29 - severe | 1 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Day 29 Erythema - severe | 0 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - Baseline - none | 14 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Baseline Erythema - Severe | 0 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - Baseline - mild | 6 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging baseline - none | 22 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - Baseline - moderate | 2 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - D29 - mild | 7 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - Baseline - severe | 1 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging baseline - mild | 3 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - D29 - none | 13 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Day 29 Erythema - none | 15 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - D29 - moderate | 6 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging baseline - moderate | 1 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - D29 - severe | 0 Participants |
| TER-101 | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Baseline Erythema - mild | 0 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - D29 - severe | 0 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Baseline Erythema - none | 15 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Baseline Erythema - mild | 2 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Baseline Erythema - moderate | 2 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Baseline Erythema - Severe | 0 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Day 29 Erythema - none | 14 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Day 29 Erythema -mild | 5 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Day 29 Erythema - moderate | 7 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Day 29 Erythema - severe | 0 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging baseline - none | 26 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging baseline - mild | 3 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging baseline - moderate | 1 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging baseline - severe | 0 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging D29 - none | 24 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging D29 - mild | 3 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging D29 - moderate | 2 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Burning/Stinging D29 - severe | 0 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - Baseline - none | 18 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - Baseline - mild | 3 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - Baseline - moderate | 2 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - Baseline - severe | 0 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - D29 - mild | 3 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - D29 - moderate | 10 Participants |
| Vehicle | Tolerability of TER-101 Ointment vs. Vehicle in Subjects With AD | Pruritis - D29 - none | 15 Participants |