Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis
- Registration Number
- NCT05072886
- Lead Sponsor
- Azora Therapeutics Australia Pty Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 34
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AT193 AT193 Topical applied daily Placebo AT193 Topical applied daily
- Primary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events 16 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia