Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000148370
Ethics application status
Approved
Date submitted
25/03/2008
Date registered
27/03/2008
Date last updated
3/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, efficacy and pharmacokinetics of 3 doses of ART621 following multiple dose administration in subjects with stable plaque psoriasis
Scientific title
A randomised, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, efficacy and pharmacokinetics of 3 doses of ART621 following multiple dose administration in subjects with stable plaque psoriasis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psoriasis 2956 0
Condition category
Condition code
Skin 3096 3096 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ART621 - subcutaneous administration of 0.5, 1.0 or 2.0mg/kg every 2 weeks for 6 injections
Intervention code [1] 2689 0
Treatment: Drugs
Comparator / control treatment
Placebo - subcutaneous adminstration of a saline and histidine buffer
Control group
Placebo

Outcomes
Primary outcome [1] 3984 0
Repeat dose safety
Timepoint [1] 3984 0
Every two weeks for 16 weeks
Secondary outcome [1] 6703 0
Pharmacokinetics
Timepoint [1] 6703 0
Pre-dose before 6 doses and 9 samples over 6 weeks post final dose
Secondary outcome [2] 6704 0
Efficacy by % change of Psoriasis Area and Severity Index (PASI) score, Physicians Global Assessment (PGA) and Dermatology Life Quality Index (DLQI)
Timepoint [2] 6704 0
Every 4 weeks for 16 weeks

Eligibility
Key inclusion criteria
Active but clinically stable, plaque psoriasis of at least 12 months duration
Psoriasis involving > 5% of the body surface area
Psoriasis of at least moderate severity. Subjects must have either a) active psoriasis despite topical therapies or b) a Physician Global Assessment rating of at least “moderate”
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Females who are either lactating or pregnant
Males and females of child bearing potential who do not agree to use, as a minimum, one medically acceptable method of contraception throughout the study period until the final study visit. Acceptable methods that may be used are abstinence, birth control pills or patch, diaphragm with spermicide, intra uterine device (coil), condom and foam, surgical sterilization or progestin implant or injection, and vasectomized partners.
Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
Evidence of skin conditions, or severe extremely psoriasis, or significant flair of psoriasis, at the time of the screening visit or between the screening visit and study drug initiation that would interfere with evaluations of the effect of Investigational Product on psoriasis.
ALT and AST > 1.5 x upper limit of normal (ULN), haemoglobin < 10 g/dL.
Clinically significant condition, infection or laboratory toxicity, at the time of the screening visit or between the screening visit and the administration of the Investigational Product that in the opinion of the Investigator would preclude participation in the study.
Evidence of clinically significant infection within 30 days of the screening visit that in the opinion of the Investigator would preclude participation in the study including hepatitis and tuberculosis. Subjects will be screened for HIV, Hepatitis B & C and tuberculosis.
Any other known infections that would in the Investigator’s discretion, interfere with the subject’s ability to participate in the study.
History or any evidence of squamous cell carcinoma or melanoma and/or current cutaneous basal cell carcinoma.
History or evidence of other malignancy.
Current or history of psychiatric disease that would interfere with the ability to comply with the study protocol or give informed consent.
History or evidence of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
Inability to restrict alcohol consumption to 2 standard drinks per day for males and 1 standard drink per day for females, for the duration of the study.
Prior use of any anti-TNF agent or other investigational biologic agent for psoriasis (including but not limited to etanercept, adalimumab, infliximab alefacept and efalizumab).
Receipt of any Investigational Product(s) within 28 days of the first dose of Investigational Product in this study.
Phototherapy (Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and UVA (PUVA)) within 14 days of the first dose of Investigational Product.
Receipt of any systemic psoriasis therapy within 28 days of the first dose of Investigational Product (including but not limited to oral or parenteral steroids, cyclosporine, methotrexate, other disease-modifying anti-rheumatic drugs (DMARDs), retinoids (e.g. acitretin) calcineurin inhibitors etc).
Topical medication within 14 days of the first dose of Investigational Product other than medicated shampoos and low potency steroids. (Excluded medications include, but are not limited to, high potency steroids, topical vitamin A or D analog preparations, anthralin or topical cyclosporine or calcineurin inhibitors).
Intravenous or oral calcineurin inhibitors such as tacrolimus (Prograf) within 28 days of the first dose of Investigational Product.
Administration of live vaccines within 14 days of the first dose of Investigational Product.
Body weight >132 kg.
Subjects with a history of liver disease including fatty liver.

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 798 0
3004
Recruitment postcode(s) [2] 799 0
5000

Funding & Sponsors
Funding source category [1] 3213 0
Commercial sector/Industry
Name [1] 3213 0
Arana Therapeutics Limited
Country [1] 3213 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Arana Therapeutics Limited
Address
Level 2, 37 Epping Road
Macquarie Park
NSW 2113
Country
Australia
Secondary sponsor category [1] 2881 0
None
Name [1] 2881 0
Address [1] 2881 0
Country [1] 2881 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5197 0
Alfred Human Research Ethics Committee`
Ethics committee address [1] 5197 0
Alfred Hospital
55 Commercial Road
Melbourne
Victoria 3004
Ethics committee country [1] 5197 0
Australia
Date submitted for ethics approval [1] 5197 0
Approval date [1] 5197 0
25/02/2008
Ethics approval number [1] 5197 0
9/08
Ethics committee name [2] 5198 0
Bellberry Limited
Ethics committee address [2] 5198 0
1st Floor, 71 Anzac Highway, Ashford, South Australia 5035
Ethics committee country [2] 5198 0
Australia
Date submitted for ethics approval [2] 5198 0
Approval date [2] 5198 0
11/03/2008
Ethics approval number [2] 5198 0
A13/08

Summary
Brief summary
The primary objective is to evaluate the safety and tolerability of subcutaneous injections of ART621 given every 2 weeks for 6 doses as assessed by adverse events and clinical laboratory data. Assessments of efficacy will include the Psoriasis Area and Severity Index (PASI), Physician Global Assessment (PGA), photographs and the Dermatology Life Quality Index (DLQI).

Each subject will be on-study for 18-20 weeks, consisting of a 2-4 week screening period, followed by a 12 week treatment period and then a 4 week follow up. Each subject will receive their designated dose of ART621 on 6 occasions over the 12 week treatment period and will be monitored closely throughout.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28460 0
Address 28460 0
Country 28460 0
Phone 28460 0
Fax 28460 0
Email 28460 0
Contact person for public queries
Name 11617 0
Robert Gay
Address 11617 0
Arana Therapeutics Limited
Level 2, 37 Epping Road
Macquarie Park
NSW 2113
Country 11617 0
Australia
Phone 11617 0
+61 2 8061 9900
Fax 11617 0
+61 2 8061 9999
Email 11617 0
clinicaltrials@arana.com
Contact person for scientific queries
Name 2545 0
Robert Gay
Address 2545 0
Level 2, 37 Epping Road
Macquarie Park
NSW 2113
Country 2545 0
Australia
Phone 2545 0
+61 2 8061 9900
Fax 2545 0
+61 2 8061 9999
Email 2545 0
clinicaltrials@arana.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

Documents added manually
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Documents added automatically
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