A Study of DLX105-DMP in Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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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

Official Title
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A Pilot, Open-Label Study in Subjects With Mild-to-Moderate Plaque Psoriasis to Investigate the Dosing Feasibility, Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multi-dose Regimen of DLX105-DMP Administered to a Target Lesion

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: DLX105-DMP


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Signed and dated informed consent. Subjects aged 18-75 years. Male subject, or if female, must be surgically sterile, post-menopausal, or using acceptable birth control. Stable chronic mild-to-moderate plaque psoriasis. Key Exclusion Criteria: Non-plaque-type psoriasis only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, or plantar) at Screening. Drug-induced psoriasis (i.e., new onset or exacerbation from beta-blockers, calcium channel inhibitors or lithium) within 3 months prior to Day 1. Ongoing use of psoriasis treatments or inadequate duration of washout prior to Day 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DLX105-DMP Multi-Dose Twice Weekly<br>4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly | Drug: DLX105-DMP<br>* 1mg applied to target lesion<br>|
| Experimental: DLX105-DMP Multi-Dose Once Weekly<br>4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly | Drug: DLX105-DMP<br>* 1mg applied to target lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | Up to 4 Weeks after Last Dose |