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NCT05072886 Clinical Trial

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

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05072886
Other study ID # NP01
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date April 1, 2022
Est. completion date August 2023

Study information
Verified date January 2023
Source Azora Therapeutics Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 34
Est. completion date August 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• AT193
Topical applied to affected areas daily

Locations
Country Name City State
Australia Sinclair Dermatology East Melbourne Victoria

Sponsors (1)
Lead Sponsor Collaborator
Azora Therapeutics Australia Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of treatment-emergent adverse events 16 weeks
See also
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