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The benefit/risk profile does not support continuation of this study.
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The purpose of the study is to assess if CC-930 is safe and tolerable in treating subjects with Discoid Lupus Erythematosus. Pharmacokinetic and pharmacodynamics will also be evaluated.
Enrollment will occur in sequential, ascending, dose-sequence design, where a higher CC-930 dose level and longer duration of dosing (cohort) will not be initiated until supportive safety profile is demonstrated in the preceding cohort. There will be 4 cohorts as described here;
Cohort 1: 25 mg once daily for 4 weeks Cohort 2: 50 mg once daily for 4 weeks Cohort 3: 100 mg once daily for 6 weeks Cohort 4: 100 mg twice daily for 6 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 25 mg daily for 4 weeks (8 active/2 control) |
|
| Cohort 2 | Experimental | 50 mg once daily for 4 weeks (8 active/2 control) |
|
| Cohort 3 | Experimental | 100 mg daily for 6 weeks (8 active/2 control) |
|
| Cohort 4 | Experimental | 100 mg twice daily for 6 weeks (8 active/2 control) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC-930 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | 4 to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To describe the pharmacokinetics of CC-930 in subjects with recalcitrant DLE. | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Smith, MD | Celgene | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Dermatology | Birmingham | Alabama | 35233 | United States | ||
| The Regents of the University of California |
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| Drug |
Placebo |
|
| Irvine |
| California |
| 92697 |
| United States |
| Medical Faculty Associates | Washington D.C. | District of Columbia | 20037 | United States |
| Advanced Pharma, CR, LLC | Miami | Florida | 33136 | United States |
| University of Miami - Department of Dermatology | Miami | Florida | 33136 | United States |
| Rush Medical Center | Chicago | Illinois | 60612 | United States |
| North Shore University Health System | Skokie | Illinois | 60077 | United States |
| SIU School of Medicine | Springfield | Illinois | 62702 | United States |
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
| John Hopkins University | Baltimore | Maryland | 21205 | United States |
| Boston Cancer Center | Boston | Massachusetts | 02118 | United States |
| University of Minnesota-Department of Dermatology | Minneapolis | Minnesota | 55455 | United States |
| University of Rochester Medical Center | Rochester | New York | 14623 | United States |
| Ohio State Univ Medical Center, Division of Dermatology | Columbus | Ohio | 43221 | United States |
| Rhode Island Hospital University Dermatology, Inc. | Providence | Rhode Island | 02903 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Dermatology and Research | Dallas | Texas | 75230 | United States |
| University of Texas Dermatology | Houston | Texas | 77030 | United States |
| Sun Research Institute | San Antonio | Texas | 78215 | United States |
| ID | Term |
|---|---|
| D008179 | Lupus Erythematosus, Discoid |
| ID | Term |
|---|---|
| D008178 | Lupus Erythematosus, Cutaneous |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C570789 | 4-(9-(tetrahydrofuran-3-yl))-8-(2,4,6-trifluorophenylamino)-9H-purin-2-ylaminocyclohexan-1-ol |
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