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

A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study Followed by an Open-Label Extension to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Topical AT193 in the Treatment of Patients With Nail Psoriasis

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05072886
Enrollment
34
Registered
2021-10-11
Start date
2022-04-01
Completion date
2023-08-31
Last updated
2023-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nail Psoriasis, Plaque Psoriasis

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

DRUGAT193

Topical applied to affected areas daily

Sponsors

Azora Therapeutics Australia Pty Ltd
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

MeasureTime frame
Incidence of treatment-emergent adverse events16 weeks

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026