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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TER-101 | Experimental | BID (twice daily) application |
|
| Vehicle | Placebo Comparator | Vehicle ointment, BID (twice daily) application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TER-101 | Drug | Active Comparator |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teres Bio site 05 | Scottsdale | Arizona | 85255 | United States | ||
| Teres Bio Site 04 |
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| ID | Title | Description |
|---|---|---|
| FG000 | TER-101 | BID (twice daily) application TER-101: Active Comparator |
| FG001 | Vehicle | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TER-101 | BID (twice daily) application TER-101: Active Comparator |
| BG001 | Vehicle | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent change | 29 days |
|
29 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TER-101 | BID (twice daily) application TER-101: Active Comparator | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Kidney infection | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Operations | Aditum Bio | (510) 227-2102 | Chris.resburg@aditumbio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 2, 2021 | Apr 28, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2021 | Apr 28, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Drug |
Placebo Comparator |
|
| 15 days |
| Change in IGA From Baseline Over Time | IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
| 29 Days |
| 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". | 29 days |
| 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) | 29 days |
| Encinitas |
| California |
| 92024 |
| United States |
| Teres Bio Site 12 | North Miami Beach | Florida | 33162 | United States |
| Teres Bio Site 10 | Tampa | Florida | 33613 | United States |
| Teres Bio Site 02 | Clarksville | Indiana | 47129 | United States |
| Teres Bio Site 01 | Louisville | Kentucky | 40241 | United States |
| Teres Bio site 09 | Saint Joseph | Missouri | 64506 | United States |
| Teres Bio Site 08 | High Point | North Carolina | 27262 | United States |
| Teres Bio Site 11 | Wilmington | North Carolina | 28405 | United States |
| Teres Bio Site 03 | College Station | Texas | 77845 | United States |
| Teres Bio Site 06 | Pflugerville | Texas | 78660 | United States |
| Teres Bio Site 07 | San Antonio | Texas | 78229 | United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| EASI | Mean | Standard Deviation | Scores on a scale |
|
| Overall IGA score | Count of Participants | Participants |
|
| WI-NRS | Mean | Standard Deviation | scores on a scale |
|
| Total body surface area | Mean | Standard Deviation | Percent of body surface area |
|
| OG001 | Vehicle | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator |
|
|
| 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. | 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. | Posted | Least Squares Mean | 95% Confidence Interval | percent | 15 days |
|
|
|
| Secondary | Change in IGA From Baseline Over Time | IGA = Investigator Global Assessment (Scale 0 - 4) 0 = Clear
| 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. | Posted | Mean | Full Range | score on a scale | 29 Days |
|
|
|
| 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". | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 29 days |
|
|
|
| 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) | 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. | Posted | Count of Participants | Participants | 29 days |
|
|
|
| 31 |
| 1 |
| 31 |
| 9 |
| 31 |
| EG001 | Vehicle | Vehicle ointment, BID (twice daily) application Vehicle: Placebo Comparator | 0 | 32 | 0 | 32 | 3 | 32 |
| Pneumonia | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Product intolerance | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Application site inflammation | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Hangover | General disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Pilonidal cyst | Infections and infestations | MedDRA version 24.0 | Non-systematic Assessment |
|
| Bundle branch block right | Cardiac disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 24.0 | Non-systematic Assessment |
|
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.
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Baseline Erythema - moderate |
|
| Baseline Erythema - Severe |
|
| Day 29 Erythema - none |
|
| Day 29 Erythema -mild |
|
| Day 29 Erythema - moderate |
|
| Day 29 Erythema - severe |
|
| Burning/Stinging baseline - none |
|
| Burning/Stinging baseline - mild |
|
| Burning/Stinging baseline - moderate |
|
| Burning/Stinging baseline - severe |
|
| Burning/Stinging D29 - none |
|
| Burning/Stinging D29 - mild |
|
| Burning/Stinging D29 - moderate |
|
| Burning/Stinging D29 - severe |
|
| Pruritis - Baseline - none |
|
| Pruritis - Baseline - mild |
|
| Pruritis - Baseline - moderate |
|
| Pruritis - Baseline - severe |
|
| Pruritis - D29 - none |
|
| Pruritis - D29 - mild |
|
| Pruritis - D29 - moderate |
|
| Pruritis - D29 - severe |
|