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A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DLX105-DMP Multi-Dose Twice Weekly | Experimental | 4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly |
|
| DLX105-DMP Multi-Dose Once Weekly | Experimental | 4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DLX105-DMP | Drug | 1mg applied to target lesion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Local Tolerability Sensations | 4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe | Up to 4 Weeks |
| Local Site Application Assessment | Investigator Assessment of Site Application Area using a 5-point scale: 0 = no visible reaction to 4 = severe erythema with induration/vesicles | Up to 4 Weeks |
| Adverse Events | Treatment Emergent Adverse Events | Day 1 through End of Study (Up to 4 Weeks after Last Dose) |
| Local Investigator Global Assessment (IGA) | Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe | Day 1 through End of Study (Up to 4 Weeks after Last Dose) |
| Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS) | Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12. | Day 1 through End of Study (Up to 4 Weeks after Last Dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Parameters | DLX105 concentrations in samples collected over time | Day 1, Day 15, and Day 25 |
| Immunogenicity Testing | Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DelArrivo Investigational Site | Alpharetta | Georgia | 30022 | United States | ||
| DelArrivo Investigational Site |
There is no current plan to make individual participant data available to other researchers; however, if study results are published, then de-identified IPD may be made available in connection with the publication.
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| Up to 4 Weeks after Last Dose |
| Philadelphia |
| Pennsylvania |
| 19103 |
| United States |
| DelArrivo Investigational Site | San Antonio | Texas | 78229 | United States |
| DelArrivo Investigational Site | Norfolk | Virginia | 23502 | United States |