A Study of DLX105-DMP in Patients With Plaque Psoriasis

Study Purpose

A Pilot, Open-Label, Two-Part Study in Subjects with Mild to Moderate Plaque Psoriasis to Investigate the Dosing Feasibility, Safety, and Local Tolerability of a Single Dose of DLX105-DMP Administered to a Target Lesion and the Safety, Local Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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-type psoriasis.
Key

Exclusion Criteria:

  • - Forms of psoriasis other than chronic plaque-type only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, plantar or nail disease) 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04203433
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

DelArrivo, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Arms & Interventions

Arms

Experimental: DLX105-DMP Single-Dose

Single-Dose of 1mg DLX105-DMP applied to a target lesion.

Experimental: DLX105-DMP Multi-Dose

4 Weeks of 1mg DLX105-DMP applied to a target lesion.

Interventions

Drug: - DLX105-DMP

1mg applied to target lesion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

DelArrivo Investigational Site, High Point, North Carolina

Status

Address

DelArrivo Investigational Site

High Point, North Carolina, 27262

Site Contact

Study Coordinator

[email protected]

919-460-9500

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