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| Name | Class |
|---|---|
| Therapeutics, Inc. | INDUSTRY |
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This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DUR-928 Topical Solution | Experimental | DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. |
|
| Vehicle Topical Solution | Placebo Comparator | Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DUR-928 Topical Solution | Drug | Topical solution containing active drug |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. | The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe. | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline as Assessed on the Target Plaque Comparison | The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B. | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Tony Andrasfay | Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 01 | San Diego | California | 92123 | United States | ||
| Site 04 |
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This was a multi-site study conducted at five sites in the United States of America. Date first subject enrolled: March 20, 2019 and date last subject completed: November 7, 2019.
| ID | Title | Description |
|---|---|---|
| FG000 | DUR-928 Topical Solution and Vehicle Topical Solution | DUR-928 Topical Solution and Vehicle Topical Solution separately applied topically once daily to one target lesion on an arm of a subject for approximately four weeks. Each arm of a subject containing one target lesion was allocated to a different intervention. DUR-928 Topical Solution: Topical solution containing active drug Vehicle Topical Solution: Topical solution containing no active drug |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Safety Population
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| ID | Title | Description |
|---|---|---|
| BG000 | DUR-928 Topical Solution and Vehicle Topical Solution | DUR-928 Topical Solution and Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. DUR-928 Topical Solution: Topical solution containing active drug Vehicle Topical Solution: Topical solution containing no active drug |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. | The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe | ITT Population | Posted | Mean | Standard Deviation | score on a scale | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) |
|
Up to Day 57
Treatment emergent adverse events (TEAE) were collected for all subjects. Information on the treatment arm was only collected if the TEAE was local to the application site.
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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 | DUR-928 Topical Solution and Vehicle Topical Solution, Safety Population | DUR-928 Topical Solution and Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks. This group reflects all TEAEs collected for the safety population, including those that are treatment application site specific. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 21.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Executive Director of Regulatory Affairs | DURECT Corporation | 408-777-1829 | jill.burns@durect.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2019 | May 26, 2022 | Prot_SAP_000.pdf |
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| Vehicle Topical Solution |
| Drug |
Topical solution containing no active drug |
|
| The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) | The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe. | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) |
| The Change From Baseline as Assessed by the Target Plaque Area. | The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured. | Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported) |
| The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. | The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable." | Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported) |
| Miami |
| Florida |
| 33162 |
| United States |
| Site 05 | Tampa | Florida | 33609 | United States |
| Site 02 | Plainfield | Indiana | 46168 | United States |
| Site 03 | Spokane | Washington | 99202 | United States |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Vehicle Topical Solution: Topical solution containing no active drug
|
|
|
| Secondary | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe. | Posted | Mean | Standard Deviation | score on a scale | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) |
|
|
|
| Secondary | The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) | The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe. | Posted | Mean | Standard Deviation | score on a scale | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) |
|
|
|
| Secondary | The Change From Baseline as Assessed by the Target Plaque Area. | The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured. | ITT population | Posted | Mean | Standard Deviation | cm^2 | Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported) |
|
|
|
| Secondary | The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. | The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable." | ITT Population | Posted | Mean | Standard Deviation | units on a scale | Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported) |
|
|
|
| Other Pre-specified | The Change From Baseline as Assessed on the Target Plaque Comparison | The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B. | ITT Population | Posted | Number | participants | Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported) |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 11 |
| 25 |
| EG001 | DUR-928 Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site. | DUR-928 Topical Solution: Topical solution containing active drug applied topically once daily to one target lesion on an arm for approximately four weeks. This treatment arm was only reported if the TEAE was local to the treatment application site. | 0 | 25 | 0 | 25 | 4 | 25 |
| EG002 | Vehicle Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site. | Vehicle Topical Solution: Topical solution containing no active drug applied topically once daily to one target lesion on an arm for approximately four weeks. This treatment arm was only reported if the TEAE was local to the treatment application site. | 0 | 25 | 0 | 25 | 3 | 25 |
| Application site erythema | General disorders | MedDRA version 21.1 | Systematic Assessment |
|
| Application site fissure | General disorders | MedDRA version 21.1 | Systematic Assessment |
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| Application site haemorrhage | General disorders | MedDRA version 21.1 | Systematic Assessment |
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| Application site injury | General disorders | MedDRA version 21.1 | Systematic Assessment |
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| Application site pain | General disorders | MedDRA version 21.1 | Systematic Assessment |
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| Application site pruritus | General disorders | MedDRA version 21.1 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA version 21.1 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA version 21.1 | Systematic Assessment |
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| Blood urine | Investigations | MedDRA version 21.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 21.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 21.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA version 21.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
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| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 21.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Systematic Assessment |
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| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 21.1 | Systematic Assessment |
|
The disclosure agreement provides that if sponsor has not submitted a manuscript for publication within 12 months after the date of data lock and analysis at study completion at all sites, the PI can review results communications prior to public release and can embargo communications regarding trial results for a period up to 120 days from the time submitted to the sponsor for review. The PI cannot disclose SPONSOR Confidential Information without prior consent.
| Week 4 (Clinical Signs of Psoriasis - scaling-Change from Baseline) |
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| Week 8 (Clinical Signs of Psoriasis - scaling-Change from Baseline) |
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| Week 4 (Clinical Signs of Psoriasis - erythema-Change from Baseline) |
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| Week 8 (Clinical Signs of Psoriasis - erythema-Change from Baseline) |
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| Week 4 : Active Worse |
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| Week 8 : Active Better |
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| Week 8 : Same |
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| Week 8 : Active Worse |
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