A Study of DLX105-DMP in Subjects With Plaque Psoriasis

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04203433
• Other study ID #: DLX105-DMP-201
• Status: Completed
• Phase: Phase 1
• Start date: March 21, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2023
• Source: DelArrivo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DLX105-DMP
1mg applied to target lesion

Locations

Country	Name	City	State
United States	DelArrivo Investigational Site	Alpharetta	Georgia
United States	DelArrivo Investigational Site	Norfolk	Virginia
United States	DelArrivo Investigational Site	Philadelphia	Pennsylvania
United States	DelArrivo Investigational Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
DelArrivo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local Tolerability Sensations	4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe	Up to 4 Weeks
Primary	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	Up to 4 Weeks
Primary	Adverse Events	Treatment Emergent Adverse Events	Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Primary	Local Investigator Global Assessment (IGA)	Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe	Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Primary	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.	Day 1 through End of Study (Up to 4 Weeks after Last Dose)
Secondary	Pharmacokinetic Parameters	DLX105 concentrations in samples collected over time	Day 1, Day 15, and Day 25
Secondary	Immunogenicity Testing	Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time	Up to 4 Weeks after Last Dose