Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis

Azora Therapeutics

Status and phase

Active, not recruiting

Phase 1

Conditions

Plaque Psoriasis

Nail Psoriasis

Treatments

Drug: AT193

Study type

Interventional

Funder types

Industry

Identifiers

NCT05072886

NP01

Details and patient eligibility

About

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.

Enrollment

34 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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