Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis (NCT05072886) | Clinical Trial Compass
UnknownPhase 1
Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis
Australia34 participantsStarted 2022-04-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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