A Phase 2 interventional study of DUR-928 Topical Solution and Vehicle Topical Solution in Plaque Psoriasis, sponsored by Durect. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-02.
Sponsored by Durect · Phase 2, Interventional, and Treatment
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 25 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Durect is the lead sponsor of 15 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.
DUR-928 Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Drug: DUR-928 Topical Solution
Vehicle Topical Solution applied topically once daily to one target lesion on an arm for approximately four weeks.
Drug: Vehicle Topical Solution
Topical solution containing active drug
Topical solution containing no active drug
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)
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)
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)
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)
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)
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)
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.
| Milestone | DUR-928 Topical Solution and Vehicle Topical Solution |
|---|---|
| Started | 25 |
| Dur-928 topical solution lesion | 25 |
| Vehicle topical solution lesion | 25 |
| Completed | 22 |
| Not completed | 3 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 2 |
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
| score on a scale | DUR-928 Topical Solution | Vehicle Topical Solution |
|---|---|---|
| Week 4 (change from baseline) | -0.8 ± 0.83 | -1.0 ± 0.93 |
| Week 8 (change from baseline) | -0.6 ± 1.00 | -0.8 ± 1.10 |
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.
| score on a scale | DUR-928 Topical Solution | Vehicle Topical Solution |
|---|---|---|
| Week 4 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline) | -1.0 ± 0.88 | -1.2 ± 0.94 |
| Week 8 (Clinical Signs of Psoriasis - Plaque Elevation-Change from Baseline) | -0.7 ± 0.98 | -0.9 ± 1.06 |
| Week 4 (Clinical Signs of Psoriasis - scaling-Change from Baseline) | -0.8 ± 0.89 | -1.1 ± 1.06 |
| Week 8 (Clinical Signs of Psoriasis - scaling-Change from Baseline) | -0.6 ± 0.95 | -0.8 ± 1.18 |
| Week 4 (Clinical Signs of Psoriasis - erythema-Change from Baseline) | -1.0 ± 0.88 | -1.1 ± 1.00 |
| Week 8 (Clinical Signs of Psoriasis - erythema-Change from Baseline) | -0.9 ± 0.97 | -1.1 ± 0.97 |
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.
| score on a scale | DUR-928 Topical Solution | Vehicle Topical Solution |
|---|---|---|
| week 4 (change from Baseline) | -2.7 ± 2.40 | -3.4 ± 2.76 |
| week 8 (change from Baseline) | -2.3 ± 2.69 | -2.8 ± 3.05 |
The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured.
| cm^2 | DUR-928 Topical Solution | Vehicle Topical Solution |
|---|---|---|
| Week 4 (change from Baseline) | -2.5 ± 11.02 | -7.4 ± 10.88 |
| Week 8 (change from Baseline) | -5.8 ± 10.26 | -8.3 ± 7.85 |
The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable."
| units on a scale | DUR-928 Topical Solution | Vehicle Topical Solution |
|---|---|---|
| Week 4 (change from baseline) | -1.7 ± 2.19 | -1.7 ± 1.84 |
| Week 8 (change from baseline) | -1.6 ± 2.34 | -1.5 ± 2.11 |
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.
| participants | DUR-928 Topical Solution and Vehicle Topical Solution |
|---|---|
| Week 4 : Active Better | 2 |
| Week 4 : Same | 13 |
| Week 4 : Active Worse | 8 |
| Week 8 : Active Better | 3 |
| Week 8 : Same | 11 |
| Week 8 : Active Worse | 8 |
Collected over Up to Day 57. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DUR-928 Topical Solution and Vehicle Topical Solution, Safety Population | 0/25 (0%) | 0/25 (0%) | 11/25 (44%) |
| DUR-928 Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site. | 0/25 (0%) | 0/25 (0%) | 4/25 (16%) |
| Vehicle Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site. | 0/25 (0%) | 0/25 (0%) | 3/25 (12%) |
| Event | DUR-928 Topical Solution and Vehicle Topical Solution, Safety Population | DUR-928 Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site. | Vehicle Topical Solution, Safety Population Experiencing a TEAE at the Treatment Application Site. |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/25 | — | — |
| Application site erythemaGeneral disorders | 1/25 | 1/25 | 1/25 |
| Application site fissureGeneral disorders | 1/25 | 1/25 | 1/25 |
| Application site haemorrhageGeneral disorders | 1/25 | 1/25 | 1/25 |
| Application site injuryGeneral disorders | 1/25 | 1/25 | 0/25 |
| Application site painGeneral disorders | 1/25 | 1/25 | 1/25 |
| Application site pruritusGeneral disorders | 1/25 | 1/25 | 1/25 |
| Ear infectionInfections and infestations | 1/25 | — | — |
| Ligament sprainInjury, poisoning and procedural complications | 1/25 | — | — |
| Blood urineInvestigations | 1/25 | — | — |
Safety Population
| Age, Continuous(years) | DUR-928 Topical Solution and Vehicle Topical Solution |
|---|---|
| Mean | 46.2 ± 11.32 |
| Sex: Female, Male(Participants) | DUR-928 Topical Solution and Vehicle Topical Solution |
|---|---|
| Female | 10 |
| Male | 15 |
| Ethnicity (NIH/OMB)(Participants) | DUR-928 Topical Solution and Vehicle Topical Solution |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 19 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | DUR-928 Topical Solution and Vehicle Topical Solution |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 22 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | DUR-928 Topical Solution and Vehicle Topical Solution |
|---|---|
| United States | 25 |
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