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The purpose of this study is to determine the safety and efficacy of voclosporin in patients with plaque psoriasis.
Psoriasis is a chronic skin condition that can have a significant impact on patient's physical and mental well being. The most common form of psoriasis is plaque psoriasis. Targeted treatments in psoriasis have been reported recently, yet cyclosporine, a calcineurin inhibitor (CNi) remains one of the treatments which has the greatest efficacy. Voclosporin represents the possibility of a calcineurin inhibitor which is not only as efficacious as cyclosporine A, but also has an improved toxicity profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Active Comparator |
| |
| 3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| voclosporin | Drug | voclosporin 0.2, 0.3, or 0.4 mg/kg BID |
|
| Measure | Description | Time Frame |
|---|---|---|
| To investigate long-term safety and tolerability of voclosporin | Sixty weeks of continuous treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the proportion of subjects achieving and/or maintaining a PASI-75 | Sixty weeks of continuous treatment | |
| To determine the proportion of subjects achieving and/or maintaining a reduction of 2 points in the SGA | Sixty weeks of continuous treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bissonnette, MD | Innovaderm Research | Principal Investigator |
| Richard Langley, MD, FRCPC | Eastern Canada Cutaneous Research Associates Ltd. | Principal Investigator |
| Gilles Lauzon, PhD MD FRCPC | University of Alberta | Principal Investigator |
| Kim Papp, MD, PhD | Probity Medical Research | Principal Investigator |
| Neil Shear, MD | Ventana Clinical Research Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isotechnika Investigational Site | Calgary | Alberta | T2S 3B3 | Canada | ||
| Isotechnika Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15371668 | Background | 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. | |
| 14672749 |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C484071 | voclosporin |
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| To evaluate the effect of voclosporin on subject quality of life | Sixty weeks of continuous treatment |
| Edmonton |
| Alberta |
| T5J 3S9 |
| Canada |
| Isotechnika Investigational Site | Vancouver | British Columbia | V5Z 3Y1 | Canada |
| Isotechnika Investigational Site | Vancouver | British Columbia | V5Z 4E8 | Canada |
| Isotechnika Investigational Site | Winnipeg | Manitoba | R3C 0N2 | Canada |
| Isotechnika Investigational Site | Moncton | New Brunswick | E1C 8X3 | Canada |
| Isotechnika Investigational Site | St. John's | Newfoundland and Labrador | A1B 3E1 | Canada |
| Isotechnika Investigational Site | St. John's | Newfoundland and Labrador | A1B 4F8 | Canada |
| Isotechnika Investigational Site | Halifax | Nova Scotia | B3H 1Z4 | Canada |
| Isotechnika Investigational Site | Barrie | Ontario | L4M 6L2 | Canada |
| Isotechnika Investigational Site | Hamilton | Ontario | L8N 1V6 | Canada |
| Isotechnika Investigational Site | London | Ontario | N5X 2P1 | Canada |
| Isotechnika Investigational Site | London | Ontario | N6A 3H7 | Canada |
| Isotechnika Investigational Site | Maple | Ontario | L4K 5V2 | Canada |
| Isotechnika Investigational Site | Markham | Ontario | L3P 1A8 | Canada |
| Isotechnika Investigational Site | Newmarket | Ontario | L3Y 6P5 | Canada |
| Isotechnika Investigational Site | North Bay | Ontario | P1B 3Z7 | Canada |
| Isotechnika Investigational Site | Oakville | Ontario | L6K 1E1 | Canada |
| Isotechnika Investigational Site | Oshawa | Ontario | L1H 1B9 | Canada |
| Isotechnika Investigational Site | Waterloo | Ontario | N2J 1C4 | Canada |
| Isotechnika Investigational Site | Windsor | Ontario | N8W 1E6 | Canada |
| Isotechnika Investigational Site | Windsor | Ontario | N8W 5L7 | Canada |
| Isotechnika Investigational Site | Laval | Quebec | H7G 2C6 | Canada |
| Isotechnika Investigational Site | Montreal | Quebec | H2K 4L5 | Canada |
| Isotechnika Investigational Site | Montreal | Quebec | H3G 1C6 | Canada |
| Isotechnika Investigational Site | Montreal | Quebec | H3H 1V4 | Canada |
| Isotechnika Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| Isotechnika Investigational Site | Saint Foy | Quebec | G1V 4X7 | Canada |
| Isotechnika Investigational Site | Sherbrooke | Quebec | J1J 2B8 | Canada |
| 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. |
| 11250240 | Background | 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. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |