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Sponsored by: |
Celgene Corporation |
Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00606450 |
There is an unmet medical need for safe, effective oral therapy for moderate-to-severe psoriasis. CC10004 will be evaluated in a controlled setting of a clinical study. The information obtained from the study will aid in the design of future clinical trials and to establish the safety and efficacy of CC10004.
Condition | Intervention | Phase |
Psoriasis |
Drug: CC10004 Drug: Placebo |
Phase II |
MedlinePlus related topics: | Psoriasis |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Comparison Study of CC10004 in Subjects With Moderate-to-Severe Plaque-Type Psoriasis |
Enrollment: | 260 |
Study Start Date: | April 2006 |
Study Completion Date: | May 2007 |
Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
20 mg of CC10004 QD
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Drug: CC10004
20 mg CC 10004 taken 1 time per day for 12 weeks
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2: Active Comparator
CC10004 BID
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Drug: CC10004
20 mg of CC10004 taken 2 times per day for 12 weeks
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3: Placebo Comparator
Placebo arm
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Drug: Placebo
matching placebo taken either 1 or 2 times per day for 12 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |||||
Division of Dermatology and Cutaneous Science | |||||
Edmonton, Alberta, Canada | |||||
Canada, British Columbia | |||||
Division of Dermatology | |||||
Vancouver, British Columbia, Canada | |||||
Canada, New Brunswick | |||||
Duronder C.P. Inc | |||||
Moncton, New Brunswick, Canada, E1C 8X3 | |||||
Canada, Nova Scotia | |||||
Eastern Canada Cutaneous Research Associates | |||||
Halifax, Nova Scotia, Canada, B3H 1Z4 | |||||
Canada, Ontario | |||||
North Bay Dermatology Centre | |||||
North Bay, Ontario, Canada, P1B3Z7 | |||||
K. Papp Clinical Research | |||||
Waterloo, Ontario, Canada, L3P 7N8 | |||||
Ultranova Skincare | |||||
Barrie, Ontario, Canada, L4M 6L2 | |||||
The Lynde Center for Dermatology | |||||
Markham, Ontario, Canada, L3P 7N8 | |||||
Dermatrials Research | |||||
Hamilton, Ontario, Canada, L8N 1V6 | |||||
Canada, Quebec | |||||
Dr Yves Poulin | |||||
Quebec City, Quebec, Canada, G1V 4X7 | |||||
Innovaderm | |||||
Montreal, Quebec, Canada, H2K 4L5 | |||||
Czech Republic | |||||
Department of Dermatovererology | |||||
Praha, Czech Republic | |||||
Department of Dermatology | |||||
Hradec Kralove, Czech Republic | |||||
Department of Dermatology | |||||
Brno, Czech Republic | |||||
Depart of Dermatology | |||||
Usti nad Labem, Czech Republic | |||||
Department of Dermatovererology | |||||
Olomouc, Czech Republic | |||||
Germany | |||||
Department of Dermatology and Venerology | |||||
Frankfurt Main, Germany | |||||
Schwerin, Germany | |||||
Salzwedel, Germany | |||||
Munster, Germany | |||||
Herborn, Germany | |||||
Berlin, Germany | |||||
Ausburg, Germany | |||||
Leipzig, Germany | |||||
Homburg, Germany | |||||
Wiesbaden, Germany | |||||
Hamburg, Germany | |||||
Mannheim, Germany | |||||
Heidelberg, Germany | |||||
Berlin, Germany | |||||
Berlin, Germany | |||||
Wurzburg, Germany | |||||
Hamburg, Germany | |||||
Department of Dermatologie and Venerology | |||||
Dresden, Germany |
Celgene Corporation |
Responsible Party: | Celgene Corporation ( Patricia Rohane, MD ) |
Study ID Numbers: | CC-10004-PSOR-003 |
First Received: | January 22, 2008 |
Last Updated: | February 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00606450 |
Health Authority: | United States: Institutional Review Board; Canada: Health Canada; Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: Ethics Committee |
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