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| Sponsored by: |
Isotechnika |
|---|---|
| Information provided by: | Isotechnika |
| ClinicalTrials.gov Identifier: | NCT00244842 |
Purpose
The purpose of this study is to determine which dose of voclosporin is effective in the treatment of plaque psoriasis compared to placebo.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: voclosporin Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Phase III, Randomized, Multicentre, Double-Blind, Placebo-Controlled Study of ISA247 in Plaque Psoriasis Patients |
| Enrollment: | 451 |
| Study Start Date: | December 2004 |
| Study Completion Date: | October 2005 |
| Primary Completion Date: | October 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Placebo Comparator |
Drug: Placebo
Placebo
|
| 2: Active Comparator |
Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
|
| 3: Active Comparator |
Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
|
| 4: Active Comparator |
Drug: voclosporin
voclosporin 0.2, 0.3, or 0.4 mg/kg po BID
|
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.
Comparison(s): Voclosporin at 3 dose levels (0.2, 0.3, and 0.4 mg/kg twice a day)compared to placebo.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Alberta | |
| Isotechnika Investigational Site | |
| Edmonton, Alberta, Canada, T5J 3S9 | |
| Isotechnika Investigational Site` | |
| Edmonton, Alberta, Canada, T5J 3S9 | |
| Isotechnika Investigational Site | |
| Calgary, Alberta, Canada, T2S 3B3 | |
| Canada, British Columbia | |
| Isotechnika Investigational Site | |
| Victoria, British Columbia, Canada, V8R 6V4 | |
| Isotechnika Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 4E8 | |
| Isotechnika Investigational Site | |
| Vancouver, British Columbia, Canada, V5Z 3Y1 | |
| Canada, Manitoba | |
| Isotechnika Investigational Site | |
| Winnipeg, Manitoba, Canada, R3C 0N2 | |
| Canada, New Brunswick | |
| Isotechnika Investigational Site | |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Canada, Newfoundland and Labrador | |
| Isotechnika Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3E1 | |
| Isotechnika Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada, A1B 4F8 | |
| Canada, Nova Scotia | |
| Isotechnika Investigational Site | |
| Halifax, Nova Scotia, Canada, B3H 1Z4 | |
| Canada, Ontario | |
| Isotechnika Investigational Site | |
| London, Ontario, Canada, N5X 2P1 | |
| Isotechnika Investigational Site | |
| Windsor, Ontario, Canada, N8W 5L7 | |
| Isotechnika Investigational Site | |
| London, Ontario, Canada, N6A 3H7 | |
| Isotechnika Investigational Site | |
| Windsor, Ontario, Canada, N8W 1E6 | |
| Isotechnika Investigational Site | |
| Waterloo, Ontario, Canada, N2J 1C4 | |
| Isotechnika Investigational Site | |
| Hamilton, Ontario, Canada, L8N 1V6 | |
| Isotechnika Investigational Site | |
| Oakville, Ontario, Canada, L6K 1E1 | |
| Isotechnika Investigational Site | |
| Toronto, Ontario, Canada, M5V 2T3 | |
| Isotechnika Investigational Site | |
| Oshawa, Ontario, Canada, L1H 1B9 | |
| Isotechnika Investigational Site | |
| Markham, Ontario, Canada, L3P 1A8 | |
| Isotechnika Investigational Site | |
| Newmarket, Ontario, Canada, L3Y 6P5 | |
| Isotechnika Investigational Site | |
| Maple, Ontario, Canada, L4K 5V2 | |
| Isotechnika Investigational Site | |
| North Bay, Ontario, Canada, L4M 6L2 | |
| Isotechnika Investigational Site | |
| North Bay, Ontario, Canada, P1B 3Z7 | |
| Canada, Quebec | |
| Isotechnika Investigational Site | |
| Laval, Quebec, Canada, H7G 2C0 | |
| Isotechnika Investigational Site | |
| Montreal, Quebec, Canada, H2K 4L5 | |
| Isotechnika Investigational Site | |
| Sherbrooke, Quebec, Canada, J1J 2B8 | |
| Isotechnika Investigational Site | |
| Ste. Foy, Quebec, Canada, G1V 4X7 | |
| Isotechnika Investigational Site | |
| Pointe Claire, Quebec, Canada, H9R 4S3 | |
| Isotechnika Investigational Site | |
| Montreal, Quebec, Canada, H3G 1C6 | |
| Principal Investigator: | Robert Bissonnette, MD | Innovaderm Research |
| Principal Investigator: | Richard Langley, MD, FRCPC | Eastern Canada Cutaneous Research Associates Ltd. |
| Principal Investigator: | Gilles Lauzon, PhD MD FRCPC | Western Canada Dermatology Institute |
| Principal Investigator: | Kim Papp, MD, PhD | Probity Medical Research |
| Principal Investigator: | Neil Shear, MD | Ventana Clinical Research Organization |
More Information
| Responsible Party: | Isotechnika Inc ( Robert Huizinga ) |
| Study ID Numbers: | ISA04-03 |
| Study First Received: | October 25, 2005 |
| Last Updated: | September 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00244842 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Randomized Controlled Trials Immunosuppression Adult Chronic Disease Dermatologic Agents Female Humans |
Male Middle Aged Severity of Illness Index Treatment Outcome Quality of Life Double-Blind Method |
|
Skin Diseases Psoriasis Quality of Life Chronic Disease Skin Diseases, Papulosquamous |
|
Skin Diseases Psoriasis Skin Diseases, Papulosquamous |