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Trial registered on ANZCTR


Registration number
ACTRN12616001077459
Ethics application status
Approved
Date submitted
3/08/2016
Date registered
10/08/2016
Date last updated
16/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An Intralesional Injection Study of DUR-928 in Psoriasis Patients
Scientific title
A Proof of Concept Study to Assess The Efficacy and Safety of Single Intralesional Doses of DUR-928 in Psoriasis Patients.
Secondary ID [1] 289838 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psoriasis 299769 0
Condition category
Condition code
Skin 299706 299706 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DUR-928 solution: 30 mg/mL DUR-928 solution after constitution with sterile vehicle solution.
Placebo for solution: The sterile vehicle solution contains hydroxypropyl betadex in phosphate buffered water.
DUR-928 suspension: 25 mg/mL DUR-928 suspension after constitution with sterile vehicle suspension.
Placebo for suspension: The sterile vehicle suspension contains polyethylene glycol in phosphate buffered water.
Active Comparator: 2mg/mL Kenalog-10 (Triamcinolone Acetonide) after dilution with sterile sodium chloride.
Treatment Control: one site will contain no intervention.
Each participant will be treated with 2 different formulations of study drug, 2 placebo (vehicle) formulations, one active comparator and one untreated area (6 treatments in total). Each treatment will be administered to every participant as three 100 microlitre intralesional injections, with the exception of the untreated area. All 5 treatments will be administered consecutively. Each treatment area is approximately 4cm^2.
The planned study treatments are:
A = DUR-928 Solution, 30 mg/mL (3 x 100 microlitre = 9 mg)
B = DUR-928 Suspension, 25 mg/mL (3 x 100 microlitre = 7.5 mg)
C = Vehicle for Solution, (3 x 100 microlitre = 0.3 mL)
D = Vehicle for Suspension, (3 x 100 microlitre = 0.3 mL)
E = Kenalog-10 (diluted) 2mg/mL (3 x 100 microlitre = 0.6 mg)
F = Untreated area
Unblinded study staff will administer all doses. Adherence to the correct dosing procedure will be documented in source data and review by an unblinded monitor. This is a single dose trial.
Intervention code [1] 295520 0
Treatment: Drugs
Comparator / control treatment
DUR-928 solution: 30 mg/mL DUR-928 solution after constitution with sterile vehicle solution.
Placebo for solution: The sterile vehicle solution contains hydroxypropyl betadex in phosphate buffered water.
DUR-928 suspension: 25 mg/mL DUR-928 suspension after constitution with sterile vehicle suspension.
Placebo for suspension: The sterile vehicle suspension contains polyethylene glycol in phosphate buffered water.
Active Comparator: 2mg/mL Kenalog-10 (Triamcinolone Acetonide) after dilution with sterile sodium chloride.
Treatment Control: one site will contain no intervention.
Each participant will be treated with 2 different formulations of study drug, 2 placebo (vehicle) formulations, one active comparator and one untreated area (6 treatments in total). Each treatment will be administered to every participant as three 100 microlitre intralesional injections, with the exception of the untreated area. All 5 treatments will be administered consecutively. Each treatment area is approximately 4cm^2.
The planned study treatments are:
A = DUR-928 Solution, 30 mg/mL (3 x 100 microlitre = 9 mg)
B = DUR-928 Suspension, 25 mg/mL (3 x 100 microlitre = 7.5 mg)
C = Vehicle for Solution, (3 x 100 microlitre = 0.3 mL)
D = Vehicle for Suspension, (3 x 100 microlitre = 0.3 mL)
E = Kenalog-10 (diluted) 2mg/mL (3 x 100 microlitre = 0.6 mg)
F = Untreated area
Unblinded study staff will administer all doses. Adherence to the correct dosing procedure will be documented in source data and review by an unblinded monitor. This is a single dose trial.
Control group
Placebo

Outcomes
Primary outcome [1] 299162 0
To establish preliminary evidence for the efficacy of intralesionally injected DUR-928 in patients with psoriasis, as assessed by microplaque assay.
Timepoint [1] 299162 0
Local Psoriasis Severity Index (LPSI): LPSI assessments will be performed by the Principal Investigator or delegate at Screening, Baseline (Day 0, pre-dose), and at each outpatient visit at Day 1, Day 2, Day 7 and Day 14. The effect of DUR-928 in psoriasis will be assessed by the change of Local Plaque Severity Index (LPSI) score as compared to vehicle in this microplaque assay.
Photography: Digital photography of the application sites will be performed at Day 0 at Baseline (pre-dose) and 2 hours post-dose, and at each outpatient visit at Day 1, Day 2, Day 7 and Day 14.
Primary outcome [2] 299163 0
To assess the safety of DUR-928 in patients with psoriasis.
Timepoint [2] 299163 0
Routine vital sign measurements (blood pressure, heart rate, respiratory rate, temperature) will be measured at screening, pre-dose and 2 hours post-dose (Day 0), and at out-patient visits on Day 1, Day 2, Day 7 and Day 14.
Physical examination will be performed at screening, pre-dose (Day 0), and at the out-patient visit on Day 14.
Safety Laboratory tests (Chemistry, Hematology and Urinalysis) will be drawn at screening, pre-dose (Day 0), and at out-patient visits on Day 2 and Day 14.
All adverse events will be collected from Screening and continues through to trial completion (Day 14).
Secondary outcome [1] 326375 0
None
Timepoint [1] 326375 0
None

Eligibility
Key inclusion criteria
Moderate to severe chronic plaque-type psoriasis;
Duration of Psoriasis of at least 6 months;
Nominated total target plaque(s) must have a total approximate area of at least 562 cm to allow application of the study treatments, and must exclude the face, scalp, shin, genitals, and groin area The total area available for treatment may be split over a maximum of two contralateral plaques of equivalent LPSI, both of which meet the eligibility requirements.
Generally healthy as determined by medical history and physical exam;
BMI less than 35 kg/m2;
Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed;
Female subjects must be of non-childbearing potential.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of non-plaque psoriasis (ie pustular, erythrodermic).
Presence of other skin condition other than psoriasis, in particular eczema, skin infections or an inherited skin disorder (other than psoriasis) that would interfere with the ability to perform study assessments.
Participation in an investigational drug study within 30 days prior to dosing.
Treatment of target plaque body region with topical medications within 2 weeks prior to dosing and during the study period.
Treatment with Vitimin A supplements within 2 weeks prior to dosing and during the study period.
Treatment with any systemic immunosuppressant medication within 6 months prior to dosing and during the study period.
Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test.

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)
10-12 participants will each be administered all 6 treatments: 2 different formulations of study drug, 2 vehicle formulations, one active comparator and one untreated area. The dose will be provided to blinded subjects by unblinded dosing staff. All other site staff will remain blinded to the treatment positions.

A central randomization schedule will be generated by the INC Research Head of Biometrics personnel – who will have no further involvement in the study. The central Randomization schedule will be provided only to the site dosing administration staff (unblinded) who will be exclusively responsible for administering the doses. Subjects will be assigned a randomization number in sequential order, as their eligibility is confirmed, by blinded site staff (who have no access to the Randomization schedule).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table/schedule generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving 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
Safety/efficacy
Statistical methods / analysis
Safety – Safety will be evaluated by assessment of clinical laboratory tests, physical examinations including vital signs, and ECGs, and by the documentation of all spontaneously reported adverse events (AEs). Treatment-emergent AEs will be tabulated by patient.

Efficacy - The effect of DUR-928 in psoriasis will be assessed by the change of LPSI score as compared to vehicle in this microplaque assay. The following evaluations will be made:
Evaluation of the drug effect within the same formulation: For each formulation within a subject’s target plaque, the comparison of drug vs the vehicle will be made by deriving the difference and its 95% Confidence Interval (CI) of the change in LPSI scores by study visit.
Evaluation of formulation effect: The difference from DUR-928 solution formulation vs DUR-928 suspension formulation within a subject’s target plaque(s) will be derived by study visit.
Microplaque assay sensitivity of the active comparator: The positive effect of the active comparator, Kenalog 'Registered Trademark', on the plaque is expected. The active comparator treatment vs each vehicle treatment and the untreated site will be compared within a subject’s target plaque(s).

No formal statistical assumptions or sample size calculations have been made for the study as this is a Proof of Concept study, wherein within each patient the ‘vehicle’ treatment is compared to the ‘active’ treatment (self-controlled study) to evaluate the signal of efficacy.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/08/2016
Actual
31/08/2016
Date of last participant enrolment
Anticipated
21/09/2016
Actual
9/11/2016
Date of last data collection
Anticipated
14/10/2016
Actual
23/11/2016
Sample size
Target
12
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 13925 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 294220 0
Commercial sector/Industry
Name [1] 294220 0
DURECT Corporation
Country [1] 294220 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
INC Research
Address
159 Port Rd, Hindmarsh
South Australia, 5007
Country
Australia
Secondary sponsor category [1] 293052 0
None
Name [1] 293052 0
Address [1] 293052 0
Country [1] 293052 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295627 0
Bellberry Limited
Ethics committee address [1] 295627 0
Ethics committee country [1] 295627 0
Australia
Date submitted for ethics approval [1] 295627 0
08/06/2016
Approval date [1] 295627 0
08/07/2016
Ethics approval number [1] 295627 0
2016-06-476

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67994 0
Dr Cathy Reid
Address 67994 0
CMAX
Level 5, 18a North Terrace,
Adelaide SA 5000
AUSTRALIA
Country 67994 0
Australia
Phone 67994 0
+ 61 8 7088 7900
Fax 67994 0
+ 61 8 7088 7999
Email 67994 0
creid@internode.on.net
Contact person for public queries
Name 67995 0
Lucy Phillips
Address 67995 0
CMAX
Level 5, 18a North Terrace,
Adelaide SA 5000
AUSTRALIA
Country 67995 0
Australia
Phone 67995 0
+ 61 8 7088 7900
Fax 67995 0
+ 61 8 7088 7999
Email 67995 0
lucy.phillips@cmax.com.au
Contact person for scientific queries
Name 67996 0
Jemma Lawson
Address 67996 0
INC Research
159 Port Road,
Hindmarsh, SA 5007, Australia
Country 67996 0
Australia
Phone 67996 0
+61 8 7202 1500
Fax 67996 0
+61 8 7202 1599
Email 67996 0
jemma.lawson@incresearch.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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