A Study of DLX105-DMP in Subjects With Plaque Psoriasis

Phase 1CompletedNCT04203433

DelArrivo, Inc.10 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plaque Psoriasis

Interventions

DLX105-DMPDRUG

1mg applied to target lesion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

DelArrivo Investigational Site

Alpharetta, Georgia, United States

DelArrivo Investigational Site

Philadelphia, Pennsylvania, United States

DelArrivo Investigational Site

San Antonio, Texas, United States

DelArrivo Investigational Site

Norfolk, Virginia, United States

Outcomes

Primary Outcomes

Local Tolerability Sensations

4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe

Time frame: 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

Time frame: Up to 4 Weeks

Adverse Events

Treatment Emergent Adverse Events

Time frame: 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

Time frame: 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.

Time frame: Day 1 through End of Study (Up to 4 Weeks after Last Dose)

Secondary Outcomes

Pharmacokinetic Parameters

DLX105 concentrations in samples collected over time

Time frame: Day 1, Day 15, and Day 25

Immunogenicity Testing

Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time

Time frame: Up to 4 Weeks after Last Dose

Data from ClinicalTrials.gov

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