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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 Apremilast in subjects with Recalcitrant (Psoriasis that has Not Responded to Therapy) Plaque-Type Psoriasis
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: apremilast |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 2, Open-label Multi-center Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Efficacy of Apremilast 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 |
|---|---|
| Experimental: Apremilast |
Drug: apremilast
20 mg PO (by mouth) twice per day (BID) for 84 days and then an additional 84 days during the optional treatment extension period. For subjects meeting the dose escalation criteria, dosage during the optional treatment extension period can be increased to 30 mg BID. Other Names:
|
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: | Elliot Rosenstein, MD, Celgene Corporation |
| ClinicalTrials.gov Identifier: | NCT00521339 History of Changes |
| Other Study ID Numbers: | CC-10004-PSOR-004 |
| Study First Received: | August 24, 2007 |
| Last Updated: | August 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
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psoriasis psoriatic arthritis recalcitrant psoriasis refractory psoriasis |
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Psoriasis Skin Diseases, Papulosquamous Skin Diseases Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents |
Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |