Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001307998
Ethics application status
Approved
Date submitted
30/09/2020
Date registered
2/12/2020
Date last updated
2/12/2020
Date data sharing statement initially provided
2/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Prospective Photographic Analysis Of Psoriasis Severity Following Treatment With Tildrakizumab
Scientific title
A Prospective Photographic Analysis Of Psoriasis Severity Following Treatment With Tildrakizumab
Secondary ID [1] 299464 0
TILDRAP001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 315448 0
Condition category
Condition code
Skin 313750 313750 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Efficacy of Tildrakizumab in adults with moderate-to-severe plaque psoriasis will be evaluated through photographic analysis from baseline to week 64.

Patients will be receiving Tildrakizumab every 12 weeks following two loading doses 4 weeks apart, by the decision of the treating physician (prior to offering this trial). Week 0 will coincide with the first loading dose, and the second will occur at Week 4, both in clinic. Subsequent observation sessions will occur immediately following administration of Tildrakizumab as scheduled.

Observational study visits will occur at scheduled visited at Week 0,4,8,16,28,40,52 and 64 with each visit requiring time to review any adverse events, concomitant medication collection, vital signs, targeted physical examination, quality of life questionnaires and full body photography administered by treating dermatologist. Each scheduled visit should take no longer than approximately 120 minutes.

Patients that chose to not enrol or are ineligible are required to be PBS-approved in order to receive Tildrakizumab treatment.
Intervention code [1] 316250 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322162 0
Changes in psoriasis severity in patients, will be assessed and documented through photographic analysis of lesions with whole body 3-D photography using Canfield Vectra WB360.
Timepoint [1] 322162 0
Weeks 0 (baseline), 4, 8, 16, 28, 40, 52 and 64.
Secondary outcome [1] 377559 0
Composite secondary outcome:

Changes in psoriasis severity in patients, will be assessed and documented through PASI assessment and physical examination by trained investigator.
Timepoint [1] 377559 0
Weeks 0 (baseline), 4, 8, 16, 28, 40, 52 and 64.
Secondary outcome [2] 377560 0
Assess the subjective impact of psoriasis treatment with Tildrakizumab, through patient responses to Dermatology Life Quality Index (DLQI).
Timepoint [2] 377560 0
Weeks 0 (baseline), 4, 8, 16, 28, 40, 52 and 64.

Eligibility
Key inclusion criteria
i) Adults (aged 18 years and above) who are eligible for systemic therapy or phototherapy.
ii) Moderate to severe plaque psoriasis with a PASI equal 15 and BSA equal 10%
iii) Minimum diagnosis of 6 months prior to Baseline
iv) Active plaque psoriasis present for at least 6 months from initial diagnosis
v) Failed to achieve an adequate response based on PASI assessment, contraindicated or intolerant to at least 3 of 4 systemic treatments for plaque psoriasis.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Previous/current treatment with IL23.
ii) Previous exposure to other biologics agents
iii) Diagnosis of other forms of psoriasis other than plaque psoriasis
iv) Pregnant or lactating women (Female participants who are pregnant, planning a pregnancy or nursing a child or not on an acceptable and highly effective birth control method)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
N/A. This a qualitative study, the resolution of psoriasis will be assessed through full-body photographs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2021
Actual
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15386 0
Sinclair Dermatology - East Melbourne
Recruitment postcode(s) [1] 28703 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 303964 0
Other
Name [1] 303964 0
Samson Clinical Pty Ltd
Country [1] 303964 0
Australia
Primary sponsor type
Other
Name
Samson Clinical Pty Ltd
Address
2 Wellington Parade
East Melbourne VIC 3002
Country
Australia
Secondary sponsor category [1] 304134 0
None
Name [1] 304134 0
Address [1] 304134 0
Country [1] 304134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304465 0
Bellberry Limited
Ethics committee address [1] 304465 0
123 Glen Osmond Road
Eastwood SA 5063
Ethics committee country [1] 304465 0
Australia
Date submitted for ethics approval [1] 304465 0
Approval date [1] 304465 0
20/09/2019
Ethics approval number [1] 304465 0
2018-10-905

Summary
Brief summary
Plaque psoriasis is a multifaceted immunological condition primarily resulting from a dysfunctional immune response with T-cells at the center of immunogenesis.

Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with moderate to severe plaque psoriasis and your treating physician has prescribed you Tildrakizumab. Your treating physician will have prescribed two loading doses of Tildrakizumab 4 weeks apart.

Study details:
This is an observational study that uses high quality photography and investigator assessments to determine changes to plaque psoriasis over a period of 64 weeks (Study visits will be conducted at week 0,4,8,16,28,40,52 and 64.).

The aim of the study is to evaluate the efficacy of Tildrakizumab in the resolution/treatment of psoriasis.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97038 0
Prof Rodney Sinclair
Address 97038 0
Sinclair Dermatology
Level 2, 2 Wellington Parade
East Melbourne VIC 3002
Country 97038 0
Australia
Phone 97038 0
+61 03 9013 0099
Fax 97038 0
Email 97038 0
[email protected]
Contact person for public queries
Name 97039 0
Jennifer Kieran
Address 97039 0
Sinclair Dermatology
Level 2, 2 Wellington Parade
East Melbourne VIC 3002
Country 97039 0
Australia
Phone 97039 0
+61 03 96542426
Fax 97039 0
Email 97039 0
[email protected]
Contact person for scientific queries
Name 97040 0
Laita Bokhari
Address 97040 0
Sinclair Dermatology
Level 3, 2 Wellington Parade
East Melbourne VIC 3002
Country 97040 0
Australia
Phone 97040 0
+61 03 9013 0099
Fax 97040 0
Email 97040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.