Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05072886




Registration number
NCT05072886
Ethics application status
Date submitted
29/09/2021
Date registered
11/10/2021
Date last updated
25/01/2023

Titles & IDs
Public title
Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis
Scientific 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
Secondary ID [1] 0 0
NP01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nail Psoriasis 0 0
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AT193

Experimental: AT193 - Topical applied daily

Placebo comparator: Placebo - Topical applied daily


Treatment: Drugs: AT193
Topical applied to affected areas daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of treatment-emergent adverse events
Timepoint [1] 0 0
16 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2023
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Azora Therapeutics Australia Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05072886
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05072886