A Study of DLX105-DMP in Subjects With Plaque Psoriasis

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

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 Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: DLX105-DMP

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • DelArrivo Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19103
      • DelArrivo Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • DelArrivo Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • DelArrivo Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: DelArrivo, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: December 16, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 30, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: DLX105-DMP-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No