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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04203433
Other study ID # DLX105-DMP-201
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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