A Study of DLX105-DMP in Subjects With Plaque Psoriasis

DelArrivo

Status and phase: Completed; Phase 1

Conditions: Plaque Psoriasis

Treatments: Drug: DLX105-DMP

Study type: Interventional

Funder types: Industry

Identifiers

NCT04203433

DLX105-DMP-201

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

DLX105-DMP Multi-Dose Twice Weekly

Experimental group

Description:

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

Treatment:

Drug: DLX105-DMP

DLX105-DMP Multi-Dose Once Weekly

Experimental group

Description:

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

Treatment:

Drug: DLX105-DMP