Plaque Psoriasis
Conditions
Brief summary
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.
Interventions
DRUGDUR-928 Topical Solution
Topical solution containing active drug
DRUGVehicle Topical Solution
Topical solution containing no active drug
Sponsors
Therapeutics, Inc.
Durect
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is a male or non-pregnant female 18 years of age or older. 2. Subject has provided written informed consent. 3. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months. 4. Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 2/Baseline. 5. Males (or their female partner) must agree to use an effective method of birth control throughout the study. 6. Subject has two similar contralateral Target Plaques. 7. Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. 8. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation.
Exclusion criteria
1. Subject is pregnant, lactating, or is planning to become pregnant during the study. 2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. 3. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis. 4. Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient during the study. 5. Subject is currently enrolled in an investigational drug or device study. 6. Subject has been previously enrolled in this study and treated with test article. Other protocol-defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. | 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 IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | 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) | 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. |
| The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) | 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 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. |
| The Change From Baseline as Assessed by the Target Plaque Area. | Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported) | The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured. |
| The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. | Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported) | The I-NRS score is based on an 11-point scale where 0 represents no itching and 10 represents worst itch imaginable. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Change From Baseline as Assessed on the Target Plaque Comparison | 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 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | DUR-928 Topical Solution and Vehicle Topical Solution |
|---|---|
| Age, Continuous | 46.2 years STANDARD_DEVIATION 11.32 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 11 / 25 | 4 / 25 | 3 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
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
Time frame: 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)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. | Week 4 (change from baseline) | -0.8 score on a scale | Standard Deviation 0.83 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. | Week 8 (change from baseline) | -0.6 score on a scale | Standard Deviation 1 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. | Week 4 (change from baseline) | -1.0 score on a scale | Standard Deviation 0.93 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. | Week 8 (change from baseline) | -0.8 score on a scale | Standard Deviation 1.1 |
Comparison: Difference in Change (week 4)p-value: 0.022Paired t-test
Comparison: Difference in Change (week 8)p-value: 0.296Paired t-test
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.
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DUR-928 Topical Solution | The Change From Baseline as Assessed by the Target Plaque Area. | Week 4 (change from Baseline) | -2.5 cm^2 | Standard Deviation 11.02 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed by the Target Plaque Area. | Week 8 (change from Baseline) | -5.8 cm^2 | Standard Deviation 10.26 |
| Vehicle Topical Solution | The Change From Baseline as Assessed by the Target Plaque Area. | Week 4 (change from Baseline) | -7.4 cm^2 | Standard Deviation 10.88 |
| Vehicle Topical Solution | The Change From Baseline as Assessed by the Target Plaque Area. | Week 8 (change from Baseline) | -8.3 cm^2 | Standard Deviation 7.85 |
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 4 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline) | -1.0 score on a scale | Standard Deviation 0.88 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 8 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline) | -0.7 score on a scale | Standard Deviation 0.98 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 4 (Clinical Signs of Psoriasis - scaling-Change from Baseline) | -0.8 score on a scale | Standard Deviation 0.89 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 8 (Clinical Signs of Psoriasis - scaling-Change from Baseline) | -0.6 score on a scale | Standard Deviation 0.95 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 4 (Clinical Signs of Psoriasis - erythema-Change from Baseline) | -1.0 score on a scale | Standard Deviation 0.88 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 8 (Clinical Signs of Psoriasis - erythema-Change from Baseline) | -0.9 score on a scale | Standard Deviation 0.97 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 4 (Clinical Signs of Psoriasis - erythema-Change from Baseline) | -1.1 score on a scale | Standard Deviation 1 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 4 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline) | -1.2 score on a scale | Standard Deviation 0.94 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 8 (Clinical Signs of Psoriasis - scaling-Change from Baseline) | -0.8 score on a scale | Standard Deviation 1.18 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 8 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline) | -0.9 score on a scale | Standard Deviation 1.06 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 8 (Clinical Signs of Psoriasis - erythema-Change from Baseline) | -1.1 score on a scale | Standard Deviation 0.97 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) | Week 4 (Clinical Signs of Psoriasis - scaling-Change from Baseline) | -1.1 score on a scale | Standard Deviation 1.06 |
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.
Time frame: Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. | Week 4 (change from baseline) | -1.7 units on a scale | Standard Deviation 2.19 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. | Week 8 (change from baseline) | -1.6 units on a scale | Standard Deviation 2.34 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. | Week 4 (change from baseline) | -1.7 units on a scale | Standard Deviation 1.84 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. | Week 8 (change from baseline) | -1.5 units on a scale | Standard Deviation 2.11 |
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.
Time frame: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) | week 4 (change from Baseline) | -2.7 score on a scale | Standard Deviation 2.4 |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) | week 8 (change from Baseline) | -2.3 score on a scale | Standard Deviation 2.69 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) | week 8 (change from Baseline) | -2.8 score on a scale | Standard Deviation 3.05 |
| Vehicle Topical Solution | The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) | week 4 (change from Baseline) | -3.4 score on a scale | Standard Deviation 2.76 |
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.
Time frame: 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)
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Target Plaque Comparison | Week 4 : Same | 13 participants |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Target Plaque Comparison | Week 4 : Active Worse | 8 participants |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Target Plaque Comparison | Week 8 : Active Better | 3 participants |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Target Plaque Comparison | Week 8 : Same | 11 participants |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Target Plaque Comparison | Week 4 : Active Better | 2 participants |
| DUR-928 Topical Solution | The Change From Baseline as Assessed on the Target Plaque Comparison | Week 8 : Active Worse | 8 participants |