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A Study of DLX105-DMP in Subjects With Plaque Psoriasis

Primary Purpose

Plaque Psoriasis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DLX105-DMP
Sponsored by
DelArrivo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plaque Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • DelArrivo Investigational Site
  • DelArrivo Investigational Site
  • DelArrivo Investigational Site
  • DelArrivo Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DLX105-DMP Multi-Dose Twice Weekly

DLX105-DMP Multi-Dose Once Weekly

Arm Description

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

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

Outcomes

Primary Outcome Measures

Local Tolerability Sensations
4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe
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
Adverse Events
Treatment Emergent Adverse Events
Local Investigator Global Assessment (IGA)
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)
Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12.

Secondary Outcome Measures

Pharmacokinetic Parameters
DLX105 concentrations in samples collected over time
Immunogenicity Testing
Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time

Full Information

First Posted
December 16, 2019
Last Updated
April 30, 2023
Sponsor
DelArrivo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04203433
Brief Title
A Study of DLX105-DMP in Subjects With Plaque Psoriasis
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DelArrivo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DLX105-DMP Multi-Dose Twice Weekly
Arm Type
Experimental
Arm Description
4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly
Arm Title
DLX105-DMP Multi-Dose Once Weekly
Arm Type
Experimental
Arm Description
4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly
Intervention Type
Drug
Intervention Name(s)
DLX105-DMP
Intervention Description
1mg applied to target lesion
Primary Outcome Measure Information:
Title
Local Tolerability Sensations
Description
4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe
Time Frame
Up to 4 Weeks
Title
Local Site Application Assessment
Description
Investigator Assessment of Site Application Area using a 5-point scale: 0 = no visible reaction to 4 = severe erythema with induration/vesicles
Time Frame
Up to 4 Weeks
Title
Adverse Events
Description
Treatment Emergent Adverse Events
Time Frame
Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Title
Local Investigator Global Assessment (IGA)
Description
Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe
Time Frame
Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Title
Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)
Description
Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12.
Time Frame
Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Secondary Outcome Measure Information:
Title
Pharmacokinetic Parameters
Description
DLX105 concentrations in samples collected over time
Time Frame
Day 1, Day 15, and Day 25
Title
Immunogenicity Testing
Description
Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time
Time Frame
Up to 4 Weeks after Last Dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
DelArrivo Investigational Site
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
DelArrivo Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
DelArrivo Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
DelArrivo Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

A Study of DLX105-DMP in Subjects With Plaque Psoriasis

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