A Study of DLX105-DMP in Subjects With Plaque Psoriasis

Phase 1

Completed

• Conditions: Plaque Psoriasis
• Interventions: Drug: DLX105-DMP

• Registration Number: NCT04203433
• Lead Sponsor: DelArrivo, Inc.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-16
• Study First Submitted QC: 2019-12-16
• Study First Posted: 2019-12-18
• Study Start: 2022-03-21
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-30
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DLX105-DMP Multi-Dose Once Weekly	DLX105-DMP	4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly
DLX105-DMP Multi-Dose Twice Weekly	DLX105-DMP	4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly

Primary Outcome Measures

Name	Time	Method
Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)	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.
Local Tolerability Sensations	Up to 4 Weeks	4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe
Local Site Application Assessment	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
Adverse Events	Day 1 through End of Study (Up to 4 Weeks after Last Dose)	Treatment Emergent Adverse Events
Local Investigator Global Assessment (IGA)	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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic Parameters	Day 1, Day 15, and Day 25	DLX105 concentrations in samples collected over time
Immunogenicity Testing	Up to 4 Weeks after Last Dose	Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time

Trial Locations

Locations (1)

DelArrivo Investigational Site; 🇺🇸 Norfolk, Virginia, United States