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

Primary Purpose

Nail Psoriasis, Plaque Psoriasis

Status
Active
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
AT193
Sponsored by
Azora Therapeutics Australia Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nail Psoriasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sinclair Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AT193

Placebo

Arm Description

Topical applied daily

Topical applied daily

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events

Secondary Outcome Measures

Full Information

First Posted
September 29, 2021
Last Updated
January 23, 2023
Sponsor
Azora Therapeutics Australia Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05072886
Brief Title
Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azora Therapeutics Australia Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nail Psoriasis, Plaque Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AT193
Arm Type
Experimental
Arm Description
Topical applied daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical applied daily
Intervention Type
Drug
Intervention Name(s)
AT193
Intervention Description
Topical applied to affected areas daily
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sinclair Dermatology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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