Double-Blind, Randomized, Placebo-controlled Comparison of CC-10004 in Subjects With Moderate to Severe Plaque Type Psoriasis (PSOR-003)
This study has been completed.
Sponsor:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00606450
First received: January 22, 2008
Last updated: August 23, 2012
Last verified: August 2012
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Purpose
There is an unmet medical need for safe, effective oral therapy for moderate-to-severe psoriasis. CC-10004 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 CC-10004.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: CC-10004 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Comparison Study of CC-10004 in Subjects With Moderate-to-Severe Plaque-Type Psoriasis |
Resource links provided by NLM:
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- To compare the clinical efficacy of 2 oral doses of CC-10004 with placebo when taken for 12 weeks in subjects with moderate-to-severe plaque-type psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the safety of CC-10004 compared with placebo in subjects with moderate-to-severe placque-type psoriasis [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- To evaluate the effects of CC-10004 compared to placebo on the quality of life in subjects with moderate-to-severe plaque-type psoriasis. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 20 mg Apremilast daily
20 mg of CC-10004 daily
|
Drug: CC-10004
20 mg CC-10004 taken 1 time per day for 12 weeks
Other Name: Apremilast
|
|
Experimental: 20mg Apremilast twice daily
CC-10004 twice daily
|
Drug: CC-10004
20 mg of CC-10004 taken 2 times per day for 12 weeks
Other Name: Apremilast
|
|
Placebo Comparator: Placebo
Placebo arm
|
Drug: Placebo
matching placebo taken either 1 or 2 times per day for 12 weeks
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must understand and voluntarily sign and informed consent form
- Must be in good health as judged by the investigator
- Must be able to adhere to the study visit schedule and other protocol requirements
- Must have greater than or equal to a 6 month history of moderate-to-severe plaque-type psoriasis
- Must have a Psoriasis Area and Severity Index (PASI) score greater than or equal to 10 and Body Surface Area (BSA) greater than or equal to 10%
- Must meet specific laboratory criteria
- Must be a candidate for photo/systemic therapy
- Women of childbearing potential must have a negative pregnancy test
Exclusion Criteria:
- Must not have clinically significant underlying disease processes
- Must not be pregnant or lactating females
- Must not have any condition, including lab abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study
- Must not have a history of active mycobacterium tuberculosis infection within 3 years prior to the screening visit
- Must not have a history of incompletely treated active of latent mycobacterium tuberculosis infection
- Must not have a know history of exposure to an infectious case of mycobacterium tuberculosis within 2 years prior to the screening visit
- Must not be an immigrant form a high-incidence country for mycobacterium tuberculosis disease within 2 years prior to the screening visit
- Must not have current erythrodermic, guttate, or pustular psoriasis
- Must not have a clinical history of failure to adequately respond to treatment in the investigator's opinion to one or more treatment courses of cyclosporine or the following biologic therapies: alefacept, etanercept, efalizumab, infliximab or adalimumab
- Must not use topical therapy within 14 days of randomization
- Must not use systemic therapy for psoriasis within 28 days of randomization
- Must not use phototherapy within 28 days of randomization
- Must not use adalimumab or infliximab within 3 months of randomization
- Must not use etanercept or efalizumab within 56 days of randomization
- Must not use alefacept within 6 months of randomization
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606450
Locations
| 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 | |
| Ultranova Skincare | |
| Barrie, Ontario, Canada, L4M 6L2 | |
| Dermatrials Research | |
| Hamilton, Ontario, Canada, L8N 1V6 | |
| The Lynde Center for Dermatology | |
| Markham, Ontario, Canada, L3P 7N8 | |
| North Bay Dermatology Centre | |
| North Bay, Ontario, Canada, P1B3Z7 | |
| K. Papp Clinical Research | |
| Waterloo, Ontario, Canada, L3P 7N8 | |
| Canada, Quebec | |
| Innovaderm | |
| Montreal, Quebec, Canada, H2K 4L5 | |
| Dr Yves Poulin | |
| Quebec City, Quebec, Canada, G1V 4X7 | |
| Czech Republic | |
| Department of Dermatology | |
| Brno, Czech Republic | |
| Department of Dermatology | |
| Hradec Kralove, Czech Republic | |
| Department of Dermatovererology | |
| Olomouc, Czech Republic | |
| Department of Dermatovererology | |
| Praha, Czech Republic | |
| Depart of Dermatology | |
| Usti nad Labem, Czech Republic | |
| Germany | |
| Celgene Clinical Site | |
| Ausburg, Germany | |
| Celgene Clinical Site | |
| Berlin, Germany | |
| Department of Dermatologie and Venerology | |
| Dresden, Germany | |
| Department of Dermatology and Venerology | |
| Frankfurt Main, Germany | |
| Celgene Clinical Site | |
| Hamburg, Germany | |
| Celgene Clinical Site | |
| Heidelberg, Germany | |
| Celgene Clinical Site | |
| Herborn, Germany | |
| Celgene Clinical Site | |
| Homburg, Germany | |
| Celgene Clinical Site | |
| Leipzig, Germany | |
| Celgene Clinical Site | |
| Mannheim, Germany | |
| Celgene Clinical Site | |
| Munster, Germany | |
| Celgene Clinical Site | |
| Salzwedel, Germany | |
| Celgene Clinical Site | |
| Schwerin, Germany | |
| Celgene Clinical Site | |
| Wiesbaden, Germany | |
| Celgene Clinical Site | |
| Wurzburg, Germany | |
Sponsors and Collaborators
Celgene Corporation
Investigators
| Study Director: | Randall Stevens | Celgene Corporation |
More Information
No publications provided
| Responsible Party: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00606450 History of Changes |
| Other Study ID Numbers: | CC-10004-PSOR-003 |
| Study First Received: | January 22, 2008 |
| Last Updated: | August 23, 2012 |
| Health Authority: | United States: Institutional Review Board Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Czech Republic: Ethics Committee |
Keywords provided by Celgene Corporation:
|
plaque psoriasis |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013