A Study of DLX105-DMP in Subjects With Plaque Psoriasis

NCT ID: NCT04203433

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DLX105-DMP Multi-Dose Twice Weekly

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

Group Type EXPERIMENTAL

DLX105-DMP

Intervention Type DRUG

1mg applied to target lesion

DLX105-DMP Multi-Dose Once Weekly

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

Group Type EXPERIMENTAL

DLX105-DMP

Intervention Type DRUG

1mg applied to target lesion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

DLX105-DMP

1mg applied to target lesion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

DelArrivo, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

DelArrivo Investigational Site

Alpharetta, Georgia, United States

Site Status

DelArrivo Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

DelArrivo Investigational Site

San Antonio, Texas, United States

Site Status

DelArrivo Investigational Site

Norfolk, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DLX105-DMP-201

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.