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

NCT ID: NCT05072886

Last Updated: 2023-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Nail Psoriasis Plaque Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AT193

Topical applied daily

Group Type EXPERIMENTAL

AT193

Intervention Type DRUG

Topical applied to affected areas daily

Placebo

Topical applied daily

Group Type PLACEBO_COMPARATOR

AT193

Intervention Type DRUG

Topical applied to affected areas daily

Interventions

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AT193

Topical applied to affected areas daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azora Therapeutics Australia Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sinclair Dermatology

East Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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NP01

Identifier Type: -

Identifier Source: org_study_id

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