Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
309 participants
INTERVENTIONAL
2005-09-30
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg BID
2
voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg BID
3
voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg BID
Interventions
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voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg BID
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with plaque psoriasis ≥ 6 months.
* Currently participating in study ISA04-03 and completed the study up to and including Visit 9 of study ISA04-03.
* Not pregnant or nursing of planning to become pregnant during the course of the study
* Sexually-active women of child-bearing potential (including those who are \< 1 year postmenopausal) and sexually-active men who are practicing a highly effective method of birth control. A highly effective method of birth control is defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly and will include implants, injectables, combined oral contraceptives, double-barrier method, sexual abstinence, or a sterile partner. Sexually-active men and women of child-bearing potential should continue to practice contraception as outlined above during treatment and for ≥ 3 months after the last dose of voclosporin.
* Written informed consent prior to any study related procedures.
* Able to keep study appointments and cooperate with all study requirements, in the opinion of the investigator.
Exclusion Criteria
* Have other dermatoses that would interfere with the evaluation of psoriasis, at the discretion of the investigator.
* A current malignancy or history of malignancy within 5 years or a history of lymphoma at any time. Subjects can be enrolled with a history of squamous or basal cell carcinoma that has been surgically excised or removed with curettage and electrodesiccation.
* Has current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals.
* Has a current streptococcal infection that required oral antibiotics.
* A known history of tuberculosis.
* Serologic evidence or known latent human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV) virus.
* Uncontrolled hypertension as defined as 3 readings of systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg.
* MDRD GFR ≤ 60 mL/min.
* Unstable renal function (variation in GFR ≥ 30%).
* Alanine transaminase, aspartate transaminase, or gamma-glutamyl transferase ≥ 3x upper limit of normal(ULN).
* White blood cell count ≤ 2.8x10 to the ninth power/L.
* Triglycerides ≥ 3x ULN.
* Is currently taking or requires the following prohibited medications or treatments during the treatment period: drugs potentiating the nephrotoxicity of voclosporin such as chronic NSAID's or ACE inhibitors, drugs interfering with it's pharmacokinetics; drugs considered to contribute to psoriasis flare; or, systemic and topical psoriasis medication (including psoralen/ultraviolet A light treatment) that may interfere with assessment of study drug efficacy.
* Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of the start of treatment. Biological agents include any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
* A history of clinically defined allergy to cyclosporine or any of the constituents of the voclosporin formulation (vitamin E, medium chain triglyceride oil, Tween 40, ethanol).
* A history of alcoholism or drug addiction within 1 year prior to study entry.
* Weighs \< 45 kg (99 lbs) or \> 140 kg (308 lbs).
* A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, or that might cause the administration of ISA247 to pose a significant risk to the subject, in the opinion of the investigator.
18 Years
66 Years
ALL
No
Sponsors
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Aurinia Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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Isotechnika
Principal Investigators
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Robert Bissonnette, MD
Role: PRINCIPAL_INVESTIGATOR
Innovaderm Research
Richard Langley, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Eastern Canada Cutaneous Research Associates Ltd.
Gilles Lauzon, PhD MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Kim Papp, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Probity Medical Research
Neil Shear, MD
Role: PRINCIPAL_INVESTIGATOR
Ventana Clinical Research Corporation
Locations
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Isotechnika Investigational Site
Calgary, Alberta, Canada
Isotechnika Investigational Site
Edmonton, Alberta, Canada
Isotechnika Investigational Site
Vancouver, British Columbia, Canada
Isotechnika Investigational Site
Vancouver, British Columbia, Canada
Isotechnika Investigational Site
Winnipeg, Manitoba, Canada
Isotechnika Investigational Site
Moncton, New Brunswick, Canada
Isotechnika Investigational Site
St. John's, Newfoundland and Labrador, Canada
Isotechnika Investigational Site
St. John's, Newfoundland and Labrador, Canada
Isotechnika Investigational Site
Halifax, Nova Scotia, Canada
Isotechnika Investigational Site
Barrie, Ontario, Canada
Isotechnika Investigational Site
Hamilton, Ontario, Canada
Isotechnika Investigational Site
London, Ontario, Canada
Isotechnika Investigational Site
London, Ontario, Canada
Isotechnika Investigational Site
Maple, Ontario, Canada
Isotechnika Investigational Site
Markham, Ontario, Canada
Isotechnika Investigational Site
Newmarket, Ontario, Canada
Isotechnika Investigational Site
North Bay, Ontario, Canada
Isotechnika Investigational Site
Oakville, Ontario, Canada
Isotechnika Investigational Site
Oshawa, Ontario, Canada
Isotechnika Investigational Site
Waterloo, Ontario, Canada
Isotechnika Investigational Site
Windsor, Ontario, Canada
Isotechnika Investigational Site
Windsor, Ontario, Canada
Isotechnika Investigational Site
Laval, Quebec, Canada
Isotechnika Investigational Site
Montreal, Quebec, Canada
Isotechnika Investigational Site
Montreal, Quebec, Canada
Isotechnika Investigational Site
Montreal, Quebec, Canada
Isotechnika Investigational Site
Pointe-Claire, Quebec, Canada
Isotechnika Investigational Site
Saint Foy, Quebec, Canada
Isotechnika Investigational Site
Sherbrooke, Quebec, Canada
Countries
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References
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Gregory CR, Kyles AE, Bernsteen L, Wagner GS, Tarantal AF, Christe KL, Brignolo L, Spinner A, Griffey SM, Paniagua RT, Hubble RW, Borie DC, Morris RE. Compared with cyclosporine, ISATX247 significantly prolongs renal-allograft survival in a nonhuman primate model. Transplantation. 2004 Sep 15;78(5):681-5. doi: 10.1097/01.tp.0000131950.75697.71.
Stalder M, Birsan T, Hubble RW, Paniagua RT, Morris RE. In vivo evaluation of the novel calcineurin inhibitor ISATX247 in non-human primates. J Heart Lung Transplant. 2003 Dec;22(12):1343-52. doi: 10.1016/s1053-2498(03)00033-0.
Abel MD, Aspeslet LJ, Freitag DG, Naicker S, Trepanier DJ, Kneteman NM, Foster RT, Yatscoff RW. ISATX247: a novel calcineurin inhibitor. J Heart Lung Transplant. 2001 Feb;20(2):161. doi: 10.1016/s1053-2498(00)00290-4. No abstract available.
Other Identifiers
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ISA05-02
Identifier Type: -
Identifier Source: org_study_id