Randomized, Placebo and Ciclosporin Controlled Study of ISA247 in Plaque Psoriasis Patients
NCT ID: NCT00408187
Last Updated: 2009-07-30
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
642 participants
INTERVENTIONAL
2006-12-31
2008-12-31
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 0.4 mg/kg po BID
3.
Placebo
Placebo
2.
Ciclosporin
ciclosporin 1.5 mg/kg po BID
Interventions
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voclosporin
voclosporin 0.4 mg/kg po BID
Ciclosporin
ciclosporin 1.5 mg/kg po BID
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with plaque psoriasis greater than or equal to 6 months prior to screening.
* Diagnosis of stable, plaque psoriasis; i.e. psoriasis must not be spontaneously improving or worsening in the 4 weeks prior to the screening visit.
* Psoriasis failing at least one systemic treatment regimen or where other systemic therapies are contraindicated or where tolerability is an issue.
* Plaque psoriasis involving greater than or equal to 10% of the body surface area and a SPGA score greater than or equal to 3 at screening and prior to randomization at the day 0 visit.
* Not pregnant or nursing.
* Sexually active women of childbearing potential or less than 1 year post-menopausal and sexually active men who are not surgically sterile must use a reliable form of birth control during study treatment and for at least 3 months after the last dose of study drug. Surgically sterile females are not considered to be of childbearing potential. Reliable forms of birth control include oral or depot contraceptives, and double-barrier methods.
* Written informed consent prior to washout and screening 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 a current, uncontrolled bacterial, viral, or fungal infection that requires intravenous antibiotics or antifungals or has had such infections within 60 days prior to screening.
* A known history of tuberculosis.
* Serologic evidence or known latent HIV, HBV or HCV virus.
* Uncontrolled hypertension of systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 90 mmHg.
* MDRD GFR \< 60 mL/min.
* Variation between the screening and Visit 1 SCr greater than or equal to 30%.
* ALT, AST, GGT greater than or equal to 2x upper limit of normal (ULN).
* White blood cell count less than or equal to 2.8 x 10 to the ninth power/L.
* Requires the following prohibited medications or treatments during the washout or treatment period: drugs potentiating the nephrotoxicity of voclosporin, drugs interfering with its pharmacokinetics, drugs considered to contribute to psoriasis flare; or, systemic and topical psoriasis medication that may interfere with assessment of study drug efficacy.
* Has used any investigational drug or device within 30 days or 10 half lives (whichever is longer) prior to the screening visit.
* Current participation in another clinical trial of any drug or biological agent.
* Has taken biological agent(s), except flu shots, tetanus shots, or boosters, within 3 months of randomization. Biological agents include any virus, live vaccine, therapeutic serum, toxin, antitoxin, monoclonal antibodies or analogous product applicable to the prevention, treatment, or cure of diseases or injuries of man.
* Previous exposure to voclosporin.
* A history of clinically defined allergy to ciclosporin, constituents of Neoral or any of the constituents of the ISA247 formulation.
* A history of alcoholism or drug addiction.
* Weighs \< 45kg (99 lbs).
* A history of disease, including mental/emotional disorder that would interfere with the subject's participation in the study, in the evaluation of his/her response or that might cause the administration of voclosporin to pose a significant risk to the subject, in the opinion of the Investigator.
18 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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Wayne Gulliver, M.D.
Role: PRINCIPAL_INVESTIGATOR
NewLab Clinical Research
Vincent Ho, M.D.
Role: PRINCIPAL_INVESTIGATOR
UBC
Andrzej Langner, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
IWOLANG
Thomas A. Luger, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Universität Münster
Slawomir Majewski, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Akademia Medyczna
Wolfram Sterry, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Charite Universitatsmedizin Berlin
Locations
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Isotechnika Investigational Site
Edmonton, Alberta, Canada
Isotechnika Investigational Site
Surrey, British Columbia, Canada
Isotechnika Investigational Site
Vancouver, British Columbia, 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
London, Ontario, Canada
Isotechnika Investigational Site
Markham, Ontario, Canada
Isotechnika Investigational Site
North Bay, Ontario, Canada
Isotechnika Investigational Site
Ottawa, Ontario, Canada
Isotechnika Investigational Site
Waterloo, Ontario, Canada
Isotechnika Investigational Site
Montreal, Quebec, Canada
Isotechnika Investigational Site
Montreal, Quebec, Canada
Isotechnika Investigational Site
Québec, Quebec, Canada
Isotechnika Investigational Site
Ausburg, , Germany
Isotechnika Investigational Site
Berlin, , Germany
Isotechnika Investigational Site
Berlin, , Germany
Isotechnika Investigational Site
Berlin, , Germany
Isotechnika Investigational Site
Berlin, , Germany
Isotechnika Investigational Site
Bochum, , Germany
Isotechnika Investigational Site
Bochum, , Germany
Isotechnika Investigational Site
Dresden, , Germany
Isotechnika Investigational Site
Dresden, , Germany
Isotechnika Investigational Site
Frankfurt, , Germany
Isotechnika Investigational Site
Geiβen, , Germany
Isotechnika Investigational Site
Hamburg, , Germany
Isotechnika Investigational Site
Hamburg, , Germany
Isotechnika Investigational Site
Kiel, , Germany
Isotechnika Investigational Site
Leipzig, , Germany
Isotechnika Investigational Site
Lübeck, , Germany
Isotechnika Investigational Site
Mahlow, , Germany
Isotechnika Investigational Site
Mainz, , Germany
Isotechnika Investigational Site
Münster, , Germany
Isotechnika Investigational Site
Potsdam, , Germany
Isotechnika Investigational Site
Salzwedel, , Germany
Isotechnika Investigational Site
Wuppertal, , Germany
Isotechnika Investigational Site
Bialystock, , Poland
Isotechnika Investigational Site
Bydgoszcz, , Poland
Isotechnika Investigational Site
Gliwice, , Poland
Isotechnika Investigational Site
Iwonicz-Zdrój, , Poland
Isotechnika Investigational Site
Krakow, , Poland
Isotechnika Investigational Site
Lodz, , Poland
Isotechnika Investigational Site
Lublin, , Poland
Isotechnika Investigational Site
Poznan, , Poland
Isotechnika Investigational Site
Szczcin, , Poland
Isotechnika Investigational Site
Warsaw, , Poland
Isotechnika Investigational Site
Warzszawa, , Poland
Isotechnika Investigational Site
Zabrze, , Poland
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.
Bissonnette R, Papp K, Poulin Y, Lauzon G, Aspeslet L, Huizinga R, Mayo P, Foster RT, Yatscoff RW, Maksymowych WP; ISA247 Psoriasis Study Group. A randomized, multicenter, double-blind, placebo-controlled phase 2 trial of ISA247 in patients with chronic plaque psoriasis. J Am Acad Dermatol. 2006 Mar;54(3):472-8. doi: 10.1016/j.jaad.2005.10.061. Epub 2006 Jan 23.
Other Identifiers
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ISA05-25
Identifier Type: -
Identifier Source: org_study_id