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| Sponsor: | Celgene Corporation |
|---|---|
| Information provided by: | Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00521339 |
Purpose
Phase 2, Open-Label, Multicenter Study to Evaluate CC-10004 in subjects with Recalcitrant (Psoriasis that has Not Responded to Therapy) Plaque-Type Psoriasis
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: CC-10004 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2, Open-label Multi-center Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of CC-10004 in Subjects With Recalcitrant Plaque-type Psoriasis |
| Enrollment: | 31 |
| Study Start Date: | August 2007 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| open-label: Experimental |
Drug: CC-10004
20 mg PO. twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension phase. 30 mg BID for subjects meeting the dose escalation protocol criteria can continue the optional treatment extension phase for an additional 84 days, starting on Day 86 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Must understand and voluntarily sign an informed consent form
Subjects must fulfill criteria outlined in at least one of the following clinical categories:
Must be able to adhere to the study visit schedule and study protocol requirements
Exclusion Criteria:
History of clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease
Contacts and Locations| United States, Massachusetts | |
| Tufts-New England Medical Center Hospitals | |
| Boston, Massachusetts, United States, 02111 | |
| United States, Missouri | |
| Central Dermatology | |
| St. Louis, Missouri, United States, 63117 | |
| United States, Oregon | |
| Oregon Medical Research Center, P.C. | |
| Portland, Oregon, United States, 97223 | |
| United States, Texas | |
| Baylor Research Institute | |
| Dallas, Texas, United States, 75246-1613 | |
| Study Director: | Robert Day, PhD | Celgene Corporation |
More Information
| Responsible Party: | Celgene Corporation ( Elliot Rosenstein, MD ) |
| Study ID Numbers: | CC-10004-PSOR-004 |
| Study First Received: | August 24, 2007 |
| Last Updated: | September 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00521339 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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psoriasis psoriatic arthritis recalcitrant psoriasis refractory psoriasis |
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Skin Diseases Psoriasis Skin Diseases, Papulosquamous |