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Completed

NCT Number: NCT04203433

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 Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

DelArrivo Investigational Site, Alpharetta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DLX105-DMP

Drug

1mg applied to target lesion

Primary outcomes

  1. Local Tolerability Sensations

    Time frame: Up to 4 Weeks

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

  2. Local Site Application Assessment

    Time frame: 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

  3. Adverse Events

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

    Treatment Emergent Adverse Events

  4. Local Investigator Global Assessment (IGA)

    Time frame: 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

  5. Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)

    Time frame: 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.

Secondary outcomes

  1. Pharmacokinetic Parameters

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

    DLX105 concentrations in samples collected over time

  2. Immunogenicity Testing

    Time frame: Up to 4 Weeks after Last Dose

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

Sponsors and collaborators

Lead sponsor

DelArrivo, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 18, 2019
Registry last updated
May 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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