Nail Psoriasis, Plaque Psoriasis
Conditions
Brief summary
Part 1 is a randomized, double-blind, placebo-controlled phase 1b study to evaluate AT193 in approximately 34 patients with nail psoriasis for 16 weeks. Part 2 is an open-label extension phase where all patients will receive active drug for an additional 16 weeks followed by a 2 week nontreatment period.
Interventions
Topical applied to affected areas daily
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosis of nail psoriasis for at least 3 months preceding study entry * Diagnosis or history of plaque psoriasis or psoriatic arthritis * A female participant of childbearing potential must use appropriate contraceptive measures during the study period * A female participant of childbearing potential must have a negative urine pregnancy test result at screening * Written informed consent must be obtained before any study procedure is performed
Exclusion criteria
* Pregnant or breastfeeding * Diagnosis of other active skin or nail diseases or skin or nail infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis * History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events | 16 weeks |
Countries
Australia