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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04203433

Enrollment

Registered

2019-12-18

Start date

2022-03-21

Completion date

2022-09-01

Last updated

2023-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plaque Psoriasis

Brief summary

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

Interventions

DRUGDLX105-DMP

1mg applied to target lesion

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Local Site Application Assessment	Up to 4 Weeks	Investigator Assessment of Site Application Area using a 5-point scale: 0 = no visible reaction to 4 = severe erythema with induration/vesicles
Local Investigator Global Assessment (IGA)	Day 1 through End of Study (Up to 4 Weeks after Last Dose)	Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe
Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)	Day 1 through End of Study (Up to 4 Weeks after Last Dose)	Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12.
Local Tolerability Sensations	Up to 4 Weeks	4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe
Adverse Events	Day 1 through End of Study (Up to 4 Weeks after Last Dose)	Treatment Emergent Adverse Events

Secondary

Measure	Time frame	Description
Immunogenicity Testing	Up to 4 Weeks after Last Dose	Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time
Pharmacokinetic Parameters	Day 1, Day 15, and Day 25	DLX105 concentrations in samples collected over time

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026